[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"meningioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:meningioma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,55,88,111,132,145,168,193,259,290,315,339,361,382,419,442,472,501,525,564,579,600,622,644,660],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100054209","phase-2-a-study-of-zanzalintinib-in-participants-with-recurrent-or-progressive-meningioma-100054209",false,"NCT07428616","A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma","A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma","STELLAR-201","Key Inclusion Criteria:\n\n* Histologically confirmed World Health Organization (WHO) grade 1, 2, or 3 meningioma.\n* Developed recurrent disease or progressive disease (PD) after receiving standard therapy (for example, surgery and\u002For radiation) or have been deemed ineligible to receive these therapies. At least 1 prior course of meningioma-directed radiotherapy is required, if not contraindicated.\n* Radiologically documented progression of any existing tumor (growth \\> 15% of the bidimensional enhancing tumor within the prior 6 months or appearance of new lesions (including intra and extracranial manifestations).\n* For participants treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval ≥ 24 weeks must have elapsed from completion of therapy to initiation of treatment.\n* Measurable disease by RANO meningioma criteria as determined by the investigator, obtained ≤ 14 days prior to initiation of treatment.\n* Karnofsky performance status (KPS) ≥ 60%.\n* Demonstrate adequate organ and marrow function within 14 days of treatment initiation\n\nKey Exclusion Criteria:\n\n* Prior history of hypertensive encephalopathy at any time.\n* Extracranial lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta.\n* Contraindication to magnetic resonance imaging (MRI).\n* Local therapy (surgery and\u002For radiation therapy) is indicated per investigator\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks or 5 half-lives, whichever is shorter, before initiation of treatment. There is no limit on prior systemic therapies\n* Prior Surgery - completed wound healing must occur prior to initiation of treatment; ≥ 8 weeks for major surgery, ≥ 7 days for minor surgery, including stereotactic biopsies.\n* The participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders, including uncontrolled hypertension,\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation,\n  * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 milliliters \\[mL\\]) of red blood within 12 weeks before initiation of treatment or other history of significant bleeding (eg, intracranial hemorrhage\u002Fbleeding), or\n  * Other clinically significant disorders.\n* Requirement for hemodialysis or peritoneal dialysis.\n* History of solid organ or allogeneic stem cell transplant.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.",[28],"Meningioma",[28,30,31,32,33,34,35,36,37,38,39,40,41],"Recurrent Meningioma","Progressive Meningioma","Atypical Meningioma","Anaplastic Meningioma","Brain","Zanzalintinib","XL092","Grade 1 Meningioma","Grade 2 Meningioma","Grade 3 Meningioma","Intracranial Neoplasms","Extracranial Meningioma","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":46},"2026-05-21",{"date":50,"type":22},"2029-09-30",{"name":52,"class":53},"Exelixis","INDUSTRY",12,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100630882","early-phase-1-pilot-study-evaluating-panitumumab-irdye800-as-an-optical-imaging-agent-to-detect-intracranial-lesions-during-neurosurgical-procedures-100630882","NCT07493447","Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures","Inclusion Criteria:\n\n* Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and\u002For radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection.\n* Subject age ≥ 18 years.\n* Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and panitumumab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include:\n\n  1. Chemistry Panel - Potassium, BUN (or urea), and Creatinine\n  2. CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count\n  3. Magnesium and Phosphorus\n* Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration.\n* Ability to understand and willingness to sign a written informed document or written informed consent via a surrogate consent rider from the patients' healthcare decision maker.\n\nExclusion Criteria:\n\n* Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment.\n* History of infusion reactions to any monoclonal antibody therapies.\n* Women who are currently pregnant or breastfeeding.\n* Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.\n* Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic.\n* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n* Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n* Patients with severe renal disease or anuria",{"count":62,"type":22},30,[64],"EARLY_PHASE1","This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.",[28,67,68,69,70],"Glioblastoma","Acoustic Neuroma","Brain Cancer","Pituitary Adenoma",[72,73,74,67,28,70,68,75,76],"Cancer","Malignant","Benign","Brain Masses","Intracranial Lesion","2026-06-26",{"date":79,"type":46},"2026-06-30",{"date":81,"type":22},"2026-07",{"date":83,"type":22},"2031-06",{"name":85,"class":86},"Eben Rosenthal","OTHER",1,{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100525811","phase-2-combination-of-everolimus-and-177lu-dotatate-in-the-treatment-of-grades-2-and-3-refractory-meningioma-a-phase-iib-clinical-trial-100525811","NCT06126588","Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial","ELUMEN","Inclusion Criteria:\n\n* Adult patient \\\u003C 80 years old, who received a complete comprehensive briefing about the trial and signed the informed consent\n* Eligible patient for compassional access program (National Multidisciplinary Neuro-Oncology board to Lutathera ® traitement\n* WHO performance status ≤ 3\n* Patient with grade 2 and 3 meningioma, substantiated by histology, not amenable to surgery or radiotherapy, with clinical or radiological progression\n* Clinical deterioration or at least 10% of tumor growth rate, defined as the product of the two largest diameters of the target lesion within 6 months\n* Expressing somatostatin receptors as determined by 68Ga-DOTATOC PET (lesion uptake ≥ liver uptake and\u002For 1.7 fold SUVpeak of the controlateral meninges).\n* Patient that underwent a brain MRI and 68Ga-DOTATOC PET within the last 2 months.\n* Effective contraception required for women of childbearing age.\n* Patient with social security cover.\n\nExclusion Criteria:\n\n* Hypersensitivity to everolimus.\n* Contraindication to 177Lu-DOTATATE: renal failure GFR\\\u003C40 mL\u002Fmin\u002F1.73m2 (calculated by the CKD-Epi Formula), hepatic failure total bilirubin \\>3N, heart failure NYHA III or IV.\n\nPatients should not take the following treatments:\n\n* Other rapamycin derivatives (sirolimus, temsirolimus, deforolimus).\n* Other immunosuppressants\n* Co-administration with potent inhibitors and inducers of CYP3A4 and\u002For the multidrug efflux pump P-glycoprotein (PgP) : Ketoconazole , itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin, Nefazodone, Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir.\n* If everolimus is taken with orally administered CYP3A4 substrates with a narrow therapeutic index (e.g. pimozide, terfenadine, astemizole, cisapride, quinidine or ergot alkaloid derivatives), the patient should be monitored for undesirable effects described in the product information of the orally administered CYP3A4 substrate.\n* Contraindication to MRI or 68Ga-DOTATOC PET\u002FCT.\n* Person referred to and L. 3212-1 and L. 3213-1 (psychiatric care).\n* Women of childbearing age without effective contraception\n* Patient unable to attend follow-ups over a 12-month period.\n* Patients who participate in an interventional clinical research trial for the duration of the ELUMEN study.\n* Individuals referred to in Articles 10, 31, 32, 33 and 34 of Regulation (EU) No 536\u002F2014.\n* Pregnant woman, birthing or breastfeeding mother\n* Minor (not emancipated)\n* Adult subject to a legal protection measure (such as guardianship, conservatorship)\n* Adult who is unable to give consent","80 Years",{"count":97,"type":22},28,[25],"Meningioma, the most common intracranial primary tumor of the central nervous system predominantly affects people in their fifties. Meningiomas are generally subdivided into two entities: a priori non-aggressive meningiomas (grade 1), and meningiomas at high risk of aggressive behavior (grade 2\u002Fatypical and 3\u002Fanaplastic). The current conventional treatments for meningioma are surgery and radiotherapy. When these treatments are no longer feasible, meningiomas are considered refractory irrespectively of grade, and in these rare entities, the therapeutic arsenal is reduced to the few treatments that have shown limited efficacy. Refractory, and particularly grades 2 and 3 meningiomas, have very poor prognoses with a progression-free survival at 6 months (PFS-6) of 26%. The European Response Assessment in Neuro-Oncology group (RANO) recommends that in any new, grades 2 and 3 meningioma, therapy that achieves a PFS-6 \\>30% in phase II trials be considered promising.\n\nIn Nuclear Medicine, Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE, currently used on a compassionate basis in refractory meningioma, deploys an octreotide-like effect, and appears very promising, with preliminary PFS-6 of 94% and an overall survival at 12 months (OS-12) of 88% in grade 1 meningioma. However, its PFS-6 is reduced to 28% with an OS-12 of 65% in WHO grades 2 and 3 meningioma. Recently the non-radiolabeled octreotide and everolimus combination however achieved a PFS-6 of 55% and an OS-12 of 75% in a population of 90% WHO grades 2 and 3 meningioma.",[28],"2026-06-23",{"date":103,"type":46},"2026-06-25",{"date":105,"type":46},"2024-11-29",{"date":107,"type":22},"2028-05-01",{"name":109,"class":86},"Central Hospital, Nancy, France",2,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":87},"100517235","phase-1-feasibility-of-acquiring-hyperpolarized-imaging-in-patients-with-meningioma-100517235","NCT06014905","Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma","Pilot\u002FPhase I Study of Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma","Inclusion Criteria:\n\n1. Known (histopathologically confirmed) or presumed meningioma based on imaging with measurable disease on MRI that shows gadolinium enhancement (at least one cm diameter) intracranially (e.g., not confined to skull base alone).\n\n   a. Thirty of the participants plan to have surgical resection within 4 weeks\n2. Participants cannot have contraindication to MRI examinations.\n3. Age \\>=18 years.\n4. Have a life expectancy of \\>12 weeks.\n5. Karnofsky Performance Status \\> 60%.\n6. Participants must have adequate renal function (creatinine \\\u003C 1.5 mg\u002FdL) before imaging. This test must be performed within 60 days prior to hyperpolarized imaging scan.\n7. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.\n8. Participants must sign an authorization for the release of their protected health information.\n\nExclusion Criteria:\n\n1. Has any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.\n2. Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥\\>=90 mmHg) despite an optimized regimen of antihypertensive medication.\n3. Has a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.\n4. Participants must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in participants of child-bearing potential.\n5. Participants must be excluded from participating in the study if they are not able to comply with the study and\u002For follow-up procedures.",{"count":119,"type":22},50,[121],"PHASE1","This is a Pilot\u002FPhase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data performed on participants with meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior",[28],"2026-06-22",{"date":103,"type":46},{"date":127,"type":46},"2023-09-01",{"date":129,"type":22},"2027-09-30",{"name":131,"class":86},"Javier Villaneuva-Meyer, MD",{"id":133,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":26,"conditions":136,"keywords":137,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":143,"locationsCount":144},"100625898",{"count":21,"type":22},[25],[28],[28,30,31,32,33,34,35,36,37,38,39,40,41],"2026-06-19",{"date":140,"type":46},"2026-06-24",{"date":48,"type":46},{"date":50,"type":22},{"name":52,"class":53},6,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":87},"100641593","phase-1-in10018-in-combination-with-dalpiciclib-for-progressive-meningiomas-100641593","NCT07652762","IN10018 in Combination With Dalpiciclib for Progressive Meningiomas","An Open-Label Phase Ib Clinical Study Evaluating the Safety, Tolerability, and Efficacy of IN10018 in Combination With Dalpiciclib in Participants With Progressive Meningiomas","Inclusion Criteria:\n\nInclusion Criteria:\n\nParticipants must be able to understand and willing to sign a written informed consent form and agree to comply with all study requirements. Written informed consent must be obtained before any study-related examination or procedure is performed.\n\nAged 18 years or older, male or female.\n\nHistologically confirmed meningioma meeting at least one of the following conditions:\n\n1. World Health Organization (WHO) Grade 2 or Grade 3 meningioma; or\n2. WHO Grade 1 meningioma that has recurred after surgery or radiotherapy and demonstrates clear radiographic or clinical progression, as determined by the investigator.\n\nNo available standard treatment option, or failure of standard treatment, including surgery, radiotherapy, or other systemic therapy.\n\nAt least 24 weeks must have elapsed since completion of radiotherapy, including external beam radiation therapy, brachytherapy, or radiosurgery such as Gamma Knife or CyberKnife.\n\nAt least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as confirmed by the investigator.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Estimated life expectancy of at least 3 months, as determined by the investigator.\n\nAdverse effects caused by previous treatments must have recovered to Grade 1 or lower according to the Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia and fatigue.\n\nThe dose of corticosteroids or other hormonal treatment must have been stable for at least 4 days before enrollment.\n\nAdequate hematologic and organ function, based on laboratory tests performed within 7 days before the first dose, as follows:\n\nHematologic function:\n\n1. Hemoglobin of at least 100 g\u002FL, without dependence on red blood cell transfusion or erythropoietin.\n2. Platelet count of at least 100 × 10\\^9\u002FL, without dependence on platelet transfusion.\n3. Absolute neutrophil count of at least 1.5 × 10\\^9\u002FL, without the use of colony-stimulating factors.\n\n   Hepatic function:\n4. Total bilirubin no greater than the upper limit of normal.\n5. Alanine aminotransferase and aspartate aminotransferase no greater than 2.5 times the upper limit of normal.\n\n   Renal function:\n6. Serum creatinine no greater than 1.5 times the upper limit of normal.\n7. Either creatinine clearance calculated using the Cockcroft-Gault formula of at least 60 mL\u002Fmin or estimated glomerular filtration rate calculated using the Modification of Diet in Renal Disease formula of at least 60 mL\u002Fmin\u002F1.73 m².\n\n   Urinary protein and coagulation function:\n8. Urine protein negative or trace. Participants with urine protein of 1+ must have a morning spot urine protein-to-creatinine ratio of less than 0.5 or 24-hour urinary protein of less than 0.5 g\u002F24 hours.\n9. International normalized ratio no greater than 1.5 and activated partial thromboplastin time no greater than 1.5 times the upper limit of normal.\n\nFemale participants must not be pregnant or breastfeeding and must meet one of the following conditions:\n\n1. Not be a woman of childbearing potential; or\n2. If a woman of childbearing potential, agree to follow the protocol-specified contraceptive requirements during study treatment and for 3 months after the last dose.\n\nExclusion Criteria:\n\nMajor surgery or major trauma within 28 days before the first dose, or diagnostic biopsy within 14 days before the first dose.\n\nReceipt of systemic anticancer treatment, including an investigational drug, within the protocol-specified washout period, including chemotherapy or targeted therapy within 14 days or 5 half-lives before the first dose, whichever is shorter, or immunotherapy within 28 days before the first dose.\n\nPrevious treatment with a focal adhesion kinase inhibitor or a cyclin-dependent kinase 4\u002F6 inhibitor, including dalpiciclib.\n\nA serious cardiovascular event or clinically significant cardiovascular condition within 6 months before initiation of study treatment, including but not limited to:\n\n1. Left ventricular ejection fraction below 50%;\n2. Corrected QT interval greater than 480 milliseconds;\n3. New York Heart Association functional class 2 or higher;\n4. History of serious arrhythmia or cardiomyopathy. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Participants with small-volume effusions detectable only by imaging may be considered eligible.\n\nMalabsorption syndrome or inability to take oral medication. Serious gastrointestinal disease, including uncontrolled inflammatory gastrointestinal disease, active Crohn disease, active ulcerative colitis, or uncontrolled gastrointestinal bleeding.\n\nActive infection that is not adequately controlled by systemic treatment. Known human immunodeficiency virus infection. Human immunodeficiency virus testing is not required during screening unless mandated by local regulations or institutional policy.\n\nKnown active hepatitis B virus or hepatitis C virus infection. Hepatitis B virus and hepatitis C virus testing is not required during screening unless mandated by local regulations or institutional policy.\n\nAny medical history, treatment, laboratory abnormality, or other condition that, in the investigator's judgment, could confound interpretation of the study results, interfere with participant compliance, or compromise the participant's safety or interests.\n\nKnown psychiatric illness or substance abuse that could interfere with compliance with study requirements.\n\nKnown hypersensitivity to IN10018, dalpiciclib, or any component of either study drug.\n\nSystemic treatment with a strong inhibitor or inducer of CYP3A4, CYP2D6, or P-glycoprotein within 14 days before the first dose, or anticipated need for such treatment during the study treatment period.",{"count":153,"type":22},24,[121],"This open-label Phase Ib study will evaluate the safety, tolerability, and preliminary effectiveness of IN10018 in combination with dalpiciclib in adults with progressive meningiomas. Progressive meningiomas are tumors arising from the membranes surrounding the brain that have continued to grow or have returned after previous treatment.\n\nParticipants will receive both study drugs by mouth in 28-day treatment cycles. IN10018 will be taken once daily throughout each cycle, and dalpiciclib will be taken once daily for 21 days followed by 7 days without dalpiciclib. Treatment may continue until the tumor progresses, unacceptable side effects occur, or another reason for stopping treatment applies.\n\nThe study includes a dose-confirmation phase and a dose-expansion phase. The main goals are to evaluate side effects and determine a recommended dose of the combination for further study. Researchers will also assess whether the treatment can shrink tumors or delay tumor growth, measure how the drugs are processed in the body, and explore tumor and blood biomarkers that may be associated with treatment response.",[28,157],"CDK4\u002F6 Inhibitor","NOT_YET_RECRUITING","2026-06-11",{"date":161,"type":46},"2026-06-17",{"date":163,"type":22},"2026-06",{"date":165,"type":22},"2029-08",{"name":167,"class":86},"Capital Medical University",{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":87},"100483520","longitudinal-prospective-study-of-neurocognition--neuroimaging-in-primary-bt-patients-100483520","NCT05576103","Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients","Longitudinal Prospective Study of Neurocognitive Outcomes and Multimodal Quantitative Neuroimaging Outcomes in Primary Brain Tumor Patients Receiving Brain Radiotherapy","Inclusion Criteria:\n\n1. Patients 18 years or older\n2. Karnofsky performance status (KPS) ≥70\n3. Life expectancy of ≥1 year\n4. Primary brain tumor patients who will receive fractionated partial brain RT\n5. Able to complete neurocognitive assessments\n\nExclusion Criteria:\n\n1. Inability to undergo MRI with contrast\n2. Prior brain RT","99 Years",{"count":177,"type":22},300,"OBSERVATIONAL","In this proposal, the investigators introduce a novel, translational study to prospectively examine primary brain tumor patients undergoing fractionated radiation therapy to the brain. Quantitative neuroimaging, radiation dose information, and directed neurocognitive testing will be acquired through this study to improve understanding of cognitive changes associated with radiation dosage to non-targeted tissue, and will provide the basis for evidence-based cognitive- sparing brain radiotherapy.",[181,182,28,183],"Primary Brain Tumor","Glioma","Schwannoma","2026-06-09",{"date":186,"type":46},"2026-06-10",{"date":188,"type":46},"2015-01",{"date":190,"type":22},"2030-12",{"name":192,"class":86},"Jona Hattangadi-Gluth",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":201,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":226,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":87},"100562786","phase-1-study-in-children-and-adolescents-of-177lu-dotatate-lutathera-combined-with-the-parp-inhibitor-olaparib-for-the-treatment-of-recurrent-or-relapsed-solid-tumours-expressing-somatostatin-receptor-sstr-luparped-100562786","NCT06607692","Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","Single-arm Open-label Phase I\u002FII Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","LUPARPED","Inclusion criteria:\n\n* 18 months - 18 years of age at the time of the initial diagnosis.\n* ≥ 3 years at the moment of inclusion in the trial.\n* Diagnosis: relapsed\u002Frefractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.\n\nThe evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):\n\n* Score = 0: Below or equal to blood pool\n* Score = 1: Above blood pool and lower than liver\n* Score = 2: Equal to or above liver and lower than spleen\n* Score = 3: Equal to or above spleen\n\nPatients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.\n\nIt is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).\n\n* Performance status ≥ 50% according to Lansky scale (\\\u003C16 years old) or Karnofsky scale (for ≥16 years old).\n* Life expectancy of at least 3 months.\n* Availability of ability to swallow tablets or capsules.\n* Adequate organ function within 28 days prior to enrolment, as defined by:\n\n  * Hb ≥10 g\u002Fdl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);\n  * White blood cell (WBC) count ≥ 2500\u002FμL (equivalent to 2.5 x 109\u002FL)\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fμl;\n  * Platelets ≥ 100.000\u002Fμl, without transfusion in the prior ≥7 days;\n  * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (assessed by 2009-Schwartz formula).\n  * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.\n  * Albumin \\>3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL)\n* A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.\n* Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.\n* Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \\\u003C18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.\n* Adequate recovery from major surgery prior to receiving study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion criteria\n\n* Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.\n* Having received more than one previous treatment with other radiolabelled somatostatin analogues.\n* Inability to swallow tablets or capsules.\n* Subjects who are currently receiving any other anticancer and\u002For investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.\n* Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.\n* Known hypersensitivity to any of the excipients.\n* Subjects who have an uncontrolled infection.\n* Lactating women.","3 Years",{"count":7,"type":22},[121,25],"Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)",[206,207,208,209,28,210,211,212,213,214,67,215,216,217,218,219,220,221,222,223,224,225],"Solid Tumor Cancer","Medulloblastoma","High Risk Neuroblastoma","High Grade Gliomas","Paraganglioma","Pheochromocytoma","Neuroendocrine Tumours (NET)","Adrenal Tumours","DIPG","Glioblastoma (GBM)","Osteosarcoma Recurrent","Carcinoma Adrenal","Synovial Sarcomas","Esthesioneuroblastoma","Neuroblastoma Recurrent","Solid Tumor Refractory to Conventional Treatment","Medulloblastoma Recurrent","Paraganglioma\u002F Phaeochromocytoma","Ependymoma","Ependymoma Recurrent",[227,228,229,230,231,232,233,234,235,236,237,238,239,214,240,241,242,243,244,245,246,247,248,224,249],"solid tumours","somatostatin receptors","SSTR","LUTETIUM","OLAPARIB","MEDULLOBLASTOMA","NEUROBLASTOMA","HIGH GRADE GLIOMA","MEININGIOMA","PARAGANGLIOMA","PHEOCHROMOCYTOMA","NEUROENDOCRINE TUMOURS","ADRENAL TUMOR","GLIOBLASTOMA","OSTEOSARCOMA","CARCINOMA ADRENAL","SYNOVIAL SARCOMA","ESTHESIONEUROBLASTOMA","RECURRENT","RELAPSED","RELAPSE","REFRACTORY","Ependimoma Recurrent","2026-06-02",{"date":252,"type":46},"2026-06-04",{"date":254,"type":46},"2024-09-20",{"date":256,"type":22},"2029-12",{"name":258,"class":86},"Fundación de investigación HM",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":87},"100624758","comparison-of-skin-closure-techniques-in-oncological-neurosurgical-procedures-intradermal-running-suture-versus-transdermal-interrupted-sutures-100624758","NCT07413796","Comparison of Skin Closure Techniques in Oncological Neurosurgical Procedures: Intradermal Running Suture Versus Transdermal Interrupted Sutures","Prospective Randomized Controlled Trial of Skin Closure Techniques in Oncological Cranial Neurosurgery: Interrupted Transdermal Sutures and Running Intradermal Suture.","NEURO-SUTURE","Inclusion Criteria:\n\n* Male or female at least 18 years old\n* Qualified for a craniotomy due to supratentorial intracranial tumor\n\nExclusion Criteria:\n\n* Revision surgery due to recurrent brain tumor\n* Emergency neurosurgical procedure\n* Scalp incision involving glabrous skin (e.g. forehead) or facial regions (e.g. eyebrow)",{"count":268,"type":22},382,[270],"NA","The purpose of this study is to compare two commonly used methods of closing the skin after surgery for an intracranial tumor. Skin closure is one of the most important steps in neurosurgical procedures, as it has a major influence on how well the wound heals. In patients with brain tumors, proper wound healing is especially important because it may affect how soon additional treatments, such as radiotherapy or chemotherapy, can be started.\n\nThere are different ways to close the skin after surgery, including running sutures and interrupted sutures. Both methods are widely used and considered safe. However, in oncological neurosurgery, there is limited scientific evidence comparing their effects, and the choice of technique is often based on the surgeon's personal experience. In this study, investigators will compare skin closure using running absorbable sutures with interrupted non-absorbable sutures. Investigators will evaluate how well, depending on used suturing methods, the wound heals and how often wound-related complications occur, such as infection, separation of the wound edges, or leakage of cerebrospinal fluid. Investigators believe that the results of this study will help improve wound care in patients undergoing neurosurgical treatment for brain tumors and, as a result, may contribute to better recovery and overall quality of life.",[273,274,28,182,67],"Brain Tumor Adult","Brain Tumor Benign",[276,277,278,279,280],"skin closure","brain tumor","intracranial tumor","glioma","meningioma","2026-05-19",{"date":283,"type":46},"2026-05-20",{"date":285,"type":46},"2026-02-01",{"date":287,"type":22},"2028-05",{"name":289,"class":86},"Medical University of Warsaw",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":298,"targetDuration":300,"studyType":178,"phases":4,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":87},"100624596","analysis-of-cerebrospinal-fluid-leakage-after-surgery-for-intracranial-tumors-100624596","NCT07411690","Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors","Cerebrospinal Fluid Leak Incidence, Management and Risk Factor After Supratentorial Craniotomy for Intracranial Tumors: a Prospective Observational Study.","CSF-IMR","Inclusion Criteria:\n\n* Male or female at least 18 years old\n* Qualified for a craniotomy due to supratentorial intracranial tumor\n\nExclusion Criteria:\n\n* Revision surgery due to recurrent brain tumor\n* Emergency neurosurgical procedure",{"count":299,"type":22},200,"6 Weeks","Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor. At the end of the operation, this covering is carefully closed again. In some cases, the closure might not be completely adequate leading to cerebrospinal fluid leak. This leakage may collect under the scalp or flow out through the surgical wound. When this happens, the surgical wound may not heal properly, and the risk of infection can increase. These complications can delay recovery and may postpone additional treatments, such as radiotherapy or chemotherapy, that are often needed after brain tumor surgery. Although cerebrospinal fluid leakage is less common after supratentorial craniotomy (surgery on the upper part of the brain) than after other types of brain surgery, it remains a challenging complication and has not been well studied in this group of patients. The aim of this study is to determine how often cerebrospinal fluid leakage occurs after supratentorial craniotomy for intracranial tumors, identify factors that increase the risk of leakage, and evaluate how these leaks are managed. Understanding these factors may help reduce the occurrence of cerebrospinal fluid leakage and improve postoperative recovery in the future.",[273,274,303,304,67,182,28],"CerebroSpinal Fluid (CSF) Leak","Craniotomy",[278,306,307,279,280],"cerebrospinal fluid leak","supratentorial craniotomy",{"date":309,"type":46},"2026-05-22",{"date":311,"type":46},"2026-02-03",{"date":313,"type":22},"2028-04",{"name":289,"class":86},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":87},"100411294","cognitive-status-after-removal-of-skull-base-meningioma-100411294","NCT04635657","Cognitive Status After Removal of Skull Base Meningioma","Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes","Inclusion Criteria:\n\n* Subject has a meningioma associated with the frontal or temporal lobes\n* Subject is scheduled to undergo open craniotomy or Endoscopic Endonasal surgery\n* Subject is 18 years of age or older\n* The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent\n* Previous surgery will not exclude the patient as a new baseline cognitive evaluation will occur.\n\nExclusion Criteria:\n\n* Patient is a prisoner\n* Patient is 90 years of age or older\n* Pregnant women\n* Previous radiation to the brain","89 Years",{"count":119,"type":22},"The purpose of this prospectively enrolling trial is to assess long-term cognitive outcomes of patients undergoing surgery for resection of a meningioma associated with the frontal and temporal lobes.",[28,326,327,328,329,330,331],"Skull Base Meningioma","Frontal Meningioma","Temporal Meningioma","Cognitive Impairment","Cognitive Decline","Post-Surgical Cognition",{"date":309,"type":46},{"date":334,"type":46},"2019-12-10",{"date":336,"type":22},"2028-12-31",{"name":338,"class":86},"Ohio State University",{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":346,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":87},"100625141","tumor-genomics-individual-risk-factors-and-external-drivers-of-health-on-health-outcomes-for-patients-with-meningioma-100625141","NCT07418775","Tumor Genomics, Individual Risk Factors, and External Drivers of Health on Health Outcomes for Patients With Meningioma","An Investigation of Tumor Genomics, Individual Risk Factors, and External Drivers of Health to Improve Health Outcomes for Patients With Meningioma","Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Able to speak and read English\n* Diagnosed with a meningioma\n\nExclusion Criteria:\n\n* Active psychiatric issues (suicidality, active psychosis, grave disability, etc.)\n* Inability to consent secondary to severe neurologic deficit or psychiatric distress\n* Inability to complete survey secondary to severe neurologic deficit or psychiatric distress",true,{"count":348,"type":22},3000,"Meningiomas are the most common primary brain tumor, and some groups are diagnosed with higher-grade tumors and have clinically worse outcomes. This study investigates social determinants of health and individual risk factors that may be associated with meningioma.",[351,28,352],"Meningioma of Brain","Brain Tumor","2026-05-15",{"date":281,"type":46},{"date":356,"type":46},"2026-01-16",{"date":358,"type":22},"2032-01-01",{"name":360,"class":86},"University of California, San Francisco",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":381,"locationsCount":87},"100558929","adjuvant-hypofractionated-stereotactic-radiosurgery-for-intermediate-risk-meningioma-100558929","NCT06557512","Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma","A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)","SRS-AIM","Inclusion Criteria:\n\n* Age \\>+ 18 years at time of study entry\n* Ability to understand and the willingness to sign a written informed consent document.\n* Histologic diagnosis of newly diagnosed World Health Organization (WHO) grade 2 or recurrent WHO grade 1 meningioma. With regard to recurrent WHO grade 1 meningioma, participants must present with radiographic evidence of recurrence, and have a histologic diagnosis of WHO grade 1 meningioma at the most recent resection.\n\n  \\* Note: For participants diagnosed outside of University of California San Francisco (UCSF), re-review of pathology at UCSF is strongly encouraged. Hematoxylin and eosin (H\\&E) slides will be reviewed by UCSF pathologists.\n* Participants must have undergone a gross-total surgical resection as deemed by their neurosurgeon (Simpson grade I-III resection), using all available information which can include post-operative MRI, of a meningioma within 180 days of enrollment.\n* Participants must have a pre-operative MRI.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score of 70 or higher)\n* Participants must have post-operative MRI indicating anatomy suitable for hypofractionated radiosurgery, as reviewed by the Radiation Oncology co-principal investigators (PIs).\n\nExclusion Criteria:\n\n* Concurrent participation in another clinical study with an investigational product unless it is an observational (non-interventional) study or the follow-up period of an interventional study.\n* Extensive multifocal (3 or more meningiomas) or metastatic disease.\n* Participants with tumors within 2mm of the optic apparatus or brainstem will be excluded.\n* Participants with another active primary malignancy or history of previous malignancy (except non-melanoma skin cancers, low and favourable-intermediate risk prostate cancers, and in situ cancers such as bladder, gastric, colon, cervical\u002Fdysplasia, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.\n* Female participants who are pregnant.\n* Any underlying medical or psychiatric condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results.\n* Participants with uncontrolled seizures, defined as greater than 3 disabling seizures per day while on anti-epileptic drugs.\n* Participants who have had previous intracranial radiotherapy overlapping with the area that would be targeted for stereotactic radiosurgery by this study.",{"count":370,"type":22},23,[270],"This clinical trial tests the safety and effectiveness of hypofractionated stereotactic radiosurgery for treating patients who have undergone surgical resection for grade II meningiomas or grade I meningiomas that have come back after a period of improvement (recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Hypofractionated stereotactic radiosurgery may be safe, tolerable, and effective in treating patients with grade II or recurrent grade I meningiomas after surgical resection.",[28,374,30],"Meningioma, Malignant","2026-05-14",{"date":377,"type":46},"2026-05-18",{"date":379,"type":46},"2024-12-13",{"date":50,"type":22},{"name":360,"class":86},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":389,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":391,"briefSummary":392,"conditions":393,"keywords":398,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":418},"100488169","phase-1-targeted-alpha-particle-therapy-for-advanced-somatostatin-receptor-type-2-sstr2-positive-tumors-100488169","NCT05636618","Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors","A Phase I\u002FIIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors","Inclusion Criteria:\n\n1. Adult (ages ≥18) PRRT-naïve subjects with NETs or meningioma by local pathology.\n2. Disease described clinically as: (a) Locally advanced\u002Funresectable or metastatic NETs for dose-finding part of the study (b) Locally advanced\u002Funresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study (c) Requiring at least 1 prior surgery (resection\u002Fbiopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma.\n3. For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3) per World Health Organization Classification of Tumors of the Central Nervous System (5th edition; WHO-CNS5)\n4. Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.\n5. Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior to enrollment.\n6. Demonstration of lesional SSTR expression: (a) For NETs: using an FDA-approved somatostatin receptor PET imaging agent, e.g. \\[68Ga\\]DOTATATE, \\[64Cu\\]DOTATATE, or \\[68Ga\\]DOTATOC (b) For meningioma: using a standard-of-care SSTR PET imaging agent within 45 days of enrollment\n7. ECOG Performance Status ≤ 1.\n8. Subjects with HIV positivity are allowed if CD4 Count \\> 350 cells\u002FμL.\n9. Concurrent Somatostatin Analog (SSA) Therapy use while on protocol therapy is allowed provided that the subject must be able to tolerate withholding long-acting SSA therapy for a minimum of 28 days and short-acting SSA therapy for a minimum of 24 hours before the first and subsequent administrations of \\[203Pb\\]VMT-α-NET or \\[212Pb\\]VMT-α-NET\n10. For NETs: Progressive Disease on approved therapies other than radionuclide therapy.\n11. For subjects with meningioma who are receiving corticosteroid treatment, the dose must be ≤ 4 mg\u002Fday dexamethasone (or other corticosteroid equivalent dose) for a minimum of 7 days before the initiation of study treatment.\n12. Must have clinically demonstrated adequate catecholamine blockade if catecholamine-secreting pheochromocytoma\u002Fparaganglioma tumors are present.\n13. Able to understand and sign informed consent and comply with all study requirements.\n14. Life expectancy \\> 3 months.\n15. Satisfactory organ function as determined by laboratory testing.\n16. For females of reproductive potential: agree to use of highly effective contraception and refrain from donating eggs (ova, oocytes) for the purpose of reproduction starting from screening, during treatment, and for at least 6 months after the last dose of \\[212Pb\\]VMT-α-NET\n17. For males of reproductive potential: agree to use of condoms or other methods to ensure effective contraception with partner and refrain from donating sperm starting from screening, during treatment, and for at least 6 months after the last dose of \\[212Pb\\]VMT-α-NET\n\nExclusion Criteria:\n\n1. Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of \\[212Pb\\]VMT-α-NET.\n2. Known additional malignancy that is progressing or requires active treatment.\n3. Pregnancy or breastfeeding a child.\n4. Febrile illness within 48 hours of any scheduled \\[212Pb\\]VMT-α-NET administration should be rescheduled \\> 48 hours after resolution of fever\\].\n5. Treatment with another investigational medicinal product within 30 days of anticipated treatment.\n6. Prior treatment with systemic PRRT based therapies (i.e., \\[90Y\\] DOTATATE\u002FDOTATOC or \\[177Lu\\] DOTATATE)\n7. Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.\n8. External beam radiation therapy (EBRT) must be completed at least 30 days prior to enrollment.\n9. Subjects who have received prior treatment with 90Y radioembolization or EBRT should have radiation absorbed dose to critical organs documented.\n10. Prior treatment with systemic anticancer therapy must be completed at least 30 days prior to enrollment (except for SSAs in subjects with functional tumors).\n11. Major surgery must be completed at least 30 days prior to enrollment.\n12. For Subjects with NETs: Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrollment and the subject has been off steroid support for at least 14 days prior to enrollment.\n13. Recently diagnosed and active infections requiring a time-limited course of antifungals or antibiotics in the 3 days prior to enrollment.\n14. Receipt of live attenuated vaccines in the 7 days prior to enrollment.\n15. Grade 3 nausea\u002Fvomiting or diarrhea within 72 hours before the of first scheduled dose of \\[212Pb\\]VMT-α-NET despite adequate antiemetic and other supportive care\n16. Known medical condition which would make this protocol unreasonably hazardous for the subject.\n17. Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the Investigational Medicinal Product or excipients.\n18. Current abuse of alcohol or illicit drugs (exclusive of use of medically prescribed cannabinoids).\n19. Existence of any medical or social issues likely to interfere with study conduct or that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions.\n20. QTc \\> 450 milliseconds for males and females.","90 Years",{"count":177,"type":22},[121,25],"This study is Phase I\u002FIIa First-in-Human Study of \\[212Pb\\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors",[394,395,396,397,210,211,28],"Neuroendocrine Tumors Unresectable","Neuroendocrine Tumor Metastatic","Gastroenteropancreatic Neuroendocrine Tumor","Bronchial Neuroendocrine Tumor",[399,400,401,402,403,404,405,406,407,408,409,28],"Radiopharmaceuticals","Somatostatin Receptor Type 2 (SSTR2)","Neuroendocrine Tumors","Metastatic Neuroendocrine Tumors","Pb-212","Theranostics","Alpha Particle Therapy","Radiotherapy","[212Pb]VMT-α-NET","VMT-α-NET-T01","Pb-203","2026-05-13",{"date":375,"type":46},{"date":413,"type":46},"2023-09-27",{"date":415,"type":22},"2029-12-26",{"name":417,"class":53},"Perspective Therapeutics",19,{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":439,"locationsCount":441},"100471909","phase-2-cabozantinib-for-patients-with-recurrent-or-progressive-meningioma-100471909","NCT05425004","Cabozantinib for Patients With Recurrent or Progressive Meningioma","A Phase II Study of Cabozantinib for Patients With Recurrent or Progressive Meningioma","Inclusion Criteria\n\n1. Histologic (preferred) or radiologic diagnosis of meningioma. All World Health Organization (WHO) grades (I, II and III) are allowed.\n2. All patients must have developed recurrent disease or progressive disease after receiving standard therapy (e.g., radiation or surgery) \\> 6 months ago or have been deemed ineligible to receive these therapies.\n3. Karnofsky Performance Status ≥ 50.\n4. Adequate hematologic function:\n\n   1. Absolute Neutrophil Count ≥ 1.5 × 10\\^9 \u002F L without granulocyte colony-stimulating factor support.\n   2. Platelet Count ≥ 100 × 10\\^9 \u002F L without transfusion.\n   3. Hemoglobin ≥ 9 g\u002FdL without transfusion within 7 days prior to screening assessment.\n5. Adequate renal function: ≥ 30 mL\u002Fmin according to the Cockcroft-Gault formula.\n6. Adequate hepatic function including:\n\n   1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN).\n   2. Aspartate transaminase (AST) ≤ 3 × ULN without liver metastasis.\n   3. Alanine transaminase (ALT) ≤ 3 × ULN without liver metastasis.\n   4. AST or ALT ≤ 5 × ULN for patients with liver metastasis.\n   5. Patients with known Gilbert's syndrome may be included if total bilirubin ≤ 3 × ULN.\n7. Patients must have measurable disease by RANO meningioma criteria.\n8. Women of childbearing potential must have negative serum pregnancy testing at screening. All women will be considered childbearing potential unless meeting criteria including:\n\n   1. Achieved post-menopausal status as defined by cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have follicular stimulation hormone showing postmenopausal state. Women who have been amenorrhoeic for ≥ 12 months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anorexia, low body weight, ovarian suppression, anti-estrogen therapy or other medically inducible reasons.\n   2. Documented hysterectomy or bilateral oophorectomy surgery.\n   3. Medically confirmed ovarian failure.\n   4. Sexually active participants and their partners must agree to use medically accepted methods of contraception during the study and for 4 months after discontinuing study treatment.\n9. Recovery of baseline CTCAE v5.0 Grade ≤ 1 toxicity related to prior study treatments unless adverse events are clinically non-significant per investigator's discretion and\u002For stable on supportive therapy if needed.\n10. Patients must be willing and able to comply with trial protocol. This includes adhering to the treatment plan, scheduled visits, laboratory and other study procedures.\n11. Serum albumin ≥ 2.8 g\u002FdL.\n12. Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) or partial thromboplastin time (PTT) test \\\u003C 1.3 × the laboratory ULN.\n\nExclusion Criteria\n\n1. Prior treatment with cabozantinib.\n2. Patients \\\u003C 18 years old.\n3. Patients who are pregnant or breast-feeding.\n4. 4\\. Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n5. Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.\n6. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) with 2 weeks before first dose of study treatment.\n7. Ejection fraction (EF) ≤ 50% by echocardiogram (ECHO). Multi-gated acquisition scan (MUGA) should be obtained to estimate EF if quality of ECHO is insufficient.\n8. Prior history of hypertensive encephalopathy at any time.\n9. History of congenital QT syndrome.\n10. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms within 14 days of study registration. If initial QTcF is \\> 500 ms, two additional EKGs separated by at least 3 minutes should be performed, and if average of these consecutive results is QTcF is ≤ 500 ms, patient is eligible.\n11. Unstable cardiac arrhythmia within 6 months prior to study registration date.\n12. Urine Protein-to-Creatinine ratio (UPCR) \\>1 mg\u002Fmg or 24-hour urine protein \\> 1 gram.\n13. History of bleeding diathesis or significant unexplained coagulopathy (e.g., in the absence of anticoagulation).\n14. Clinical signs or symptoms of gastrointestinal obstruction requiring parenteral hydration, nutrition or feeding tube.\n15. Uncontrolled effusion management (pleural effusion, pericardial effusion or ascites) requiring recurrent drainage procedures.\n16. Active infection requiring parenteral antibiotic therapy.\n17. History of either positive hepatitis C virus (HCV) RNA viral load or detectable anti-HCV antibody; hepatitis B virus (HBV) infection with HBV surface antigen detection and\u002For positive HBV DNA viral load.\n18. Serious non-healing wound, ulcer, or bone fracture requiring intervention within 28 days prior to study registration date.\n19. Known hypersensitivity to cabozantinib or any component in formulation.\n20. Inability to swallow capsules, known intolerance to cabozantinib or its excipients, known malabsorption syndrome, or other conditions which impair intestinal absorption.\n21. Other severe acute or chronic medical conditions, which may increase study risk per treating investigator's discretion.\n22. Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n    1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n23. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n    a. Cardiovascular disorders: i. Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.\n\n    ii. Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n\n    iii. Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.\n\n    iv. Subjects with a diagnosis of incidental, sub-segmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of study treatment.\n\n    b. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: i. The subject has evidence of any concurrent malignancy invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.\n\n    ii. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.\n\n    Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n24. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n25. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease from another malignancy.\n26. Other clinically significant disorders that would preclude safe study participation.\n\n    1. Serious non-healing wound\u002Fulcer\u002Fbone fracture.\n    2. Uncompensated\u002Fsymptomatic hypothyroidism.\n    3. Moderate to severe hepatic impairment (Child-Pugh B or C).\n27. Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible",{"count":153,"type":22},[25],"A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma",[28],[28,431,432,433],"central nervous system tumors","Recurrent meningioma","Progression meningioma","2026-05-12",{"date":375,"type":46},{"date":437,"type":46},"2022-06-01",{"date":287,"type":22},{"name":440,"class":86},"Baptist Health South Florida",3,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":18,"minAge":449,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":453,"conditions":454,"keywords":458,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":144},"100391232","phase-2-innovative-trial-for-understanding-the-impact-of-targeted-therapies-in-nf2-related-schwannomatosis-intuitt-nf2-100391232","NCT04374305","Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)","INTUITT-NF2","Eligibility Specific For MASTER PROTOCOL:\n\nInclusion Criteria:\n\n\\- Patients must have a pathogenic variant in the NF2 gene (either in the germline or in two NF2-related tumors) OR a confirmed diagnosis of NF2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria:\n\nThe NIH criteria includes presence of:\n\n* Bilateral vestibular schwannomas, OR\n* First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity.\n\nThe Manchester criteria includes presence of:\n\n* Bilateral vestibular schwannomas, OR\n* First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\n* Unilateral vestibular schwannoma AND any two of: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\n* Multiple meningiomas (two or more) AND unilateral vestibular schwannoma OR any two of: schwannoma, glioma, neurofibroma, cataract.\n\nSubjects must have a target NF2-related tumor (VS, non-VS, meningioma, or ependymoma) with documented radiographic progression within the preceding 36 months of Master Study registration defined as either:\n\n* at least 20% increase in volume of enhancing tumor\n* at least 2 mm increase in greatest linear dimension of enhancing tumor\n\nParticipants must have measurable disease, defined as:\n\n* VS, non-VS, or meningioma target lesions that can be accurately measured as at least 1 ml by volumetric MRI scan or in at least one dimension as ≥10 mm with conventional MRI scan. See protocol for the evaluation of measurable disease\n* Ependymoma target lesions measurable linearly.\n\nParticipant must have a target NF2-related tumor with the following qualities:\n\n* Not amenable to surgery due to patient refusal or due to high risk for surgical complications (e.g., damage to nerve function). Participant must be ≥ 12 years of age on Day 1 of treatment. Life expectancy of greater than 1 year Karnofsky performance status ≥ 70 or ECOG PS 0 or 1 (see Appendix A). Ability to understand and the willingness to sign written informed consent and assent documents.\n* Must have established relationship with primary care physician and provide contact information\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy within a minimum of 4 weeks prior to Master Study registration (or a minimum of 5 half-lives and resolution to baseline of toxicities unless there are irreversible toxicities from prior drug that do not influence risk of next drug).\n* Participants who have received radiation to the target tumor within the last 3 years prior to Master study registration.\n* Participants who are receiving any other investigational agents.\n* Participants with target or non-target nervous system tumors that, in the opinion of the treating investigator, are likely to require active treatment (including surgery) within 6 months of registration to the Master Study.\n* History of a different malignancy, unless (a) have been disease-free for at least 2 years and are deemed by the treating investigator to be at low risk for recurrence of that malignancy.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because the experimental agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these experimental agents, breastfeeding should be discontinued if the mother is treated.\n\nEligibility Criteria Specific to SUB-STUDY A (Brigatinib arm): CLOSED TO ENROLLMENT\n\nInclusion criteria\n\n* Participants must meet all eligibility criteria outlined in the Master Study\n* Participants must be willing and able to provide written informed consent\u002Fassent for the brigatinib arm of the INTUITT-NF2 trial.\n* Participant is ≥ 12 years of age and has body weight at least 40 kg on Day 1 of treatment.\n* Patient must be able to swallow pills.\n* Clinical laboratory values as specified below within 28 days before the first dose of study drug, as described in the protocol document:\n* Female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age group and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below:\n\nFemale patients must meet 1 of the following:\n\n* Postmenopausal for at least 1 year before the screening visit, or\n* Surgically sterile, or\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing of the informed consent form through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse. Brigatinib may decrease effectiveness of hormonal contraceptives, therefore, women are recommended to use non-hormonal methods of contraception. Highly effective non-hormonal birth control for women of child bearing potential with male partners includes:\n\n  * Sexual abstinence (no sexual intercourse)\n  * Intrauterine device (IUD) or intrauterine system (IUS)\n  * Bilateral tubal ligation (both tubes tied)\n  * Vasectomized partner\n\nMale patients, even if surgically sterilized (i.e., status post-vasectomy) must agree to 1 of the following:\n\n\\- Practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from heterosexual intercourse.\n\nExclusion criteria:\n\n* Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug (if applicable)\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n* Treatment with any investigational products within 1 month or 5 half-lives (whichever is longer) before the first dose of study drug\n* Had major surgery within 30 days of the first dose of brigatinib. Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.\n* Have significant, uncontrolled, or active cardiovascular disease (as outlined in the protocol):\n* Have uncontrolled hypertension (defined as an average systolic blood pressure \\>160 or an average diastolic blood pressure \\>100 for adults; for children: please refer to table in protocol\n\nEligibility Criteria Specific to SUB-STUDY B (Neratinib arm):\n\n* Participants must be willing and able to provide written informed consent\u002Fassent for the neratinib arm of the INTUITT-NF2 trial.\n* Participant must be ≥ 12 years of age and have body weight ≥ 40 kg on Day 1 of treatment.\n* Patient must be able to swallow pills.\n* Recovery (ie, to Grade 1 or baseline) from all clinically significant AEs related to prior therapies (excluding alopecia, neuropathy, and nail changes).\n* Clinical laboratory values as specified below within 14 days before the first dose of study drug:\n* ALT\u002Faspartate aminotransferase (AST) ≤ 2.5 × institutional upper limit of normal (ULN);\n* Total serum bilirubin ≤ 1.5 × institutional ULN (\\\u003C3.0 × institutional ULN for patients with Gilbert syndrome)\n* Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2, using the modification of diet in renal disease (MDRD) equation\n* Serum lipase ≤1.5 × institutional ULN\n* Absolute neutrophil count ≥1.5 × 109\u002FL\n* Platelet count ≥75 × 109\u002FL\n* Hemoglobin ≥9 g\u002FdL\n* Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO).\n* It is not known what effects neratinib has on human pregnancy or development of the embryo or fetus. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age group and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below:\n\nFemale patients must meet 1 of the following:\n\n* Postmenopausal for at least 1 year before the screening visit, or\n* Surgically sterile, or\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing of the informed consent form through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse. Neratinib may decrease effectiveness of hormonal contraceptives, therefore, women are recommended to use non-hormonal methods of contraception. Highly effective non-hormonal birth control for women of child bearing potential with male partners includes:\n\n  * Sexual abstinence (no sexual intercourse)\n  * Intrauterine device (IUD) or intrauterine system (IUS)\n  * Bilateral tubal ligation (both tubes tied)\n  * Vasectomized partner\n\nMale patients, even if surgically sterilized (i.e., status post-vasectomy) must agree to 1 of the following:\n\n* Practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from heterosexual intercourse.\n* Female patients must have negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause. \\[Women are considered postmenopausal if they are ≥12 months without menses, in the absence of endocrine or anti-endocrine therapies.\\]\n\nExclusion Criteria\n\n* Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug (if applicable)\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n* Treatment with any investigational products within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug\n* Had major surgery within 30 days of the first dose of neratinib. Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.\n* Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n* Myocardial infarction within 6 months before the first dose of neratinib.\n* Unstable angina within 6 months before first dose of neratinib.\n* Congestive heart failure within 6 months before first dose of neratinib.\n* History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician.\n* Any history of clinically significant ventricular arrhythmia.\n* Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of neratinib.\n* QTc interval \\>0.450 seconds (males) or \\>0.470 (females), or known history of QTc prolongation or Torsade de Pointes (TdP)\n* Have a known history of HIV infection. Testing is not required in the absence of history.\n* Have malabsorption syndrome or other GI illness that could affect oral absorption of neratinib. Note: This includes any predisposing chronic condition resulting in baseline grade 2 or higher diarrhea\n* History of severe allergic reactions or intolerability attributed to compounds of similar chemical or biologic composition to neratinib.\n* Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of neratinib.\n* Concurrent use of enzyme-inducing antiepileptic drugs (EIAEDs), including phenytoin, carbamazepine, oxcarbazepine, fosphenytoin, phenobarbital, pentobarbital, or primidone\n* Received systemic treatment with certain cytochrome P-450 inhibitors or inducers within 14 days before enrollment.\n\nEnrollment Criteria Specific to SUB-STUDY C (retifanlimab plus bevacizumab arm):\n\nInclusion Criteria\n\n* Participants must be willing and able to provide written informed consent\u002Fassent for the retifanlimab-bevacizumab arm of the INTUITT-NF2 trial.\n* Participants must have a target NF2-related tumor (VS, non-VS, meningioma, or ependymoma) with documented radiographic progression within the preceding 36-months.\n* Age between 12 and 25 years on day 1 of treatment.\n* Life expectancy of greater than 1 year.\n* Participants must meet the following organ and marrow function as defined below:\n\n  1. Leukocytes ≥3000\u002FmcL\n  2. Platelets ≥100,000\u002FmcL\n  3. Total Bilirubin ≤ 1.5 institutional upper limit of normal (ULN), (\\\u003C3.0 × institutional ULN for patients with Gilbert Syndrome)\n  4. AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN\n  5. Urine Protein:Creatinine Ratio ≤ 1.9\n  6. Glomerular Filtration Rate (GFR) ≥30 mL\u002Fmin\u002F1.73 m2\n* Inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age group and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below:\n\nFemale patients must meet 1 of the following:\n\n* Postmenopausal, defined as ≥12 consecutive months of amenorrhea in the absence of endocrine or anti-endocrine therapy, for a minimum of 1 year prior to screening visit, or\n* Surgically sterile, or\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing of the informed consent form through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse. Highly effective non-hormonal birth control for women of childbearing potential with male partners may include:\n* Sexual abstinence (no sexual intercourse)\n* Intrauterine device (IUD) or intrauterine system (IUS)\n* Bilateral tubal ligation (both tubes tied)\n* Vasectomized partner Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to 1 of the following:\n* Practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or\n* Completely abstain from heterosexual intercourse.\n\nExclusion Criteria\n\n* History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to retifanlimab or bevacizumab\n* Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period prior to registration.\n* Treatment with any investigational products or chemotherapy within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug.\n* Treatment with bevacizumab or any PD-1\u002FPD-L1 inhibitor within 180 days before the first dose of study drug.\n* Had major surgery within 30 days of the first dose of study drug. Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.\n* Serious or non-healing wound, ulcer, or bone fracture.\n* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to Day 1.\n* Imaging (CT or MRI) evidence of hemorrhage deemed significant by the treating physician (\\> grade 1). Subjects with significantly increased risk of CNS hemorrhage are not eligible.\n* Concurrent use of anti-coagulant drugs (not including prophylactic doses), history of coagulopathy, or evidence of bleeding diathesis or coagulopathy.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.\n* Immune related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).\n\n  1. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  2. Participants with asthma that requires intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections may participate.\n  3. Participants using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption) may participate.\n  4. Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedications are permitted.\n* Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 10 days before first dose of study treatment.\n* Has received a live vaccine within 28 days before the planned start of study treatment (with the exception of COVID-19 vaccines).\n\nNote: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.\n\n* History of organ transplant, including allogeneic stem cell transplantation.\n* Clinically significant cardiovascular disease, such as:\n* Inadequately controlled HTN (defined as an average systolic blood pressure \\>160 or an average diastolic blood pressure \\> 100 for adult patients ≥ 21 years and as an average systolic BP \\> 130 or an average diastolic blood pressure \\>80 for pediatric patients 12-21 years) despite adequate treatment with medications. Patients with hypertension should be under treatment on study entry to control blood pressure.\n* History of CVA within 12 months of registration\n* Myocardial infarction or unstable angina within 12 months of registration\n* New York heart association grade II or greater congestive heart failure\n* Serious and inadequately controlled cardiac arrhythmia\n* Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection)\n* Clinically significant peripheral vascular disease","12 Years",{"count":451,"type":22},109,[25],"This is a multi-arm phase II platform-basket screening study designed to test multiple experimental therapies simultaneously in patients with NF2-related schwannomatosis (NF2-SWN, formerly known as neurofibromatosis type 2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas.\n\nThis Master Study is being conducted as a \"basket\" study that may allow people with multiple tumor types associated with NF2-SWN to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies.\n\n* Investigational Drug Sub-study A: Brigatinib\n* Investigational Drug Sub-study B: Neratinib\n* Investigational Drug Sub-study C: Retifanlimab plus bevacizumab",[455,456,457,28,224],"Neurofibromatosis Type 2","Vestibular Schwannoma","Non-vestibular Schwannoma",[459,460,461,280,462],"neurofibromatosis type 2 (NF2)","vestibular schwannomas (VS)","non-vestibular schwannomas (non-VS)","ependymoma","2026-05-04",{"date":465,"type":46},"2026-05-06",{"date":467,"type":46},"2020-06-20",{"date":469,"type":22},"2030-12-01",{"name":471,"class":86},"Scott R. Plotkin, MD, PhD",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":481,"briefSummary":482,"conditions":483,"keywords":487,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":441},"100577927","phase-2-pharmacoscopy-for-patients-with-refractory-primary-brain-tumors-100577927","NCT06804655","Pharmacoscopy for Patients With Refractory Primary Brain Tumors","EViDENCE-BT","Inclusion Criteria:\n\n1. Age 18 years or older on day of signing informed consent, female or male.\n2. Refractory glioblastoma, isocitrate dehydrogenase (IDH)-mutant astrocytoma or oligodendroglioma, histone-mutant glioma, ependymoma, medulloblastoma, meningioma or other rare primary brain tumor with a histological confirmation according to the WHO classification 2021. Primary tumors can be located at the cerebral or spinal level. Primary brain tumors with metastases outside of the brain may also be considered.\n3. Karnofsky performance status of 60 or more\n4. Life expectancy \\>12 weeks.\n5. Limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.\n6. Surgery clinically indicated. A histological confirmation of the diagnosis of a recurrent brain tumor will be required before any treatment can be initiated.\n7. Adequate bone marrow, renal and hepatic function\n8. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.\n9. Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.\n\nExclusion Criteria:\n\n1. Inability to undergo brain or spine MRI.\n2. Concurrent treatment with other systemic tumor-directed pharmacotherapies.\n3. Intent to be treated with radiotherapy.\n4. Any investigational antitumor therapy other than those under investigation in this study.\n5. Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions and requirements.\n6. Intention to become pregnant during the course of the study or pregnancy. Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test.\n7. Women who are breast feeding and who do not agree to discontinue nursing prior to the first study treatment and for the period defined in the protocol.\n8. Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.",{"count":480,"type":22},40,[25],"Advanced technology of ex vivo drug profiling referred to as pharmacoscopy may allow to identify novel drugs for the treatment of glioblastoma and other refractory brain tumors at an individual patient level. This personalized therapeutic approach was developed and validated in pre-clinical glioma models. With the current research proposal, we seek to establish feasibility for a clinical interventional trial for patients with refractory primary brain tumors that is based on pharmacoscopy-guided selection of treatment.\n\nThe study is supported by an unrestricted grant from Anti Cancer Fund.",[484,67,182,224,207,28,485,486],"Brain (Nervous System) Cancers","Rare Primary Brain Tumors","Rare CNS Primary Tumors",[488,489,490,491,492],"pharmacoscopy","drug testing","refractory tumor","drug repurposing","personalized medicine","2026-04-29",{"date":465,"type":46},{"date":496,"type":22},"2026-06-01",{"date":498,"type":22},"2028-09-15",{"name":500,"class":86},"University of Zurich",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":520,"leadSponsor":522,"locationsCount":524},"100633996","phase-2-a-study-of-jzp3507-onc206-in-recurrent-grade-2-or-3-meningioma-100633996","NCT07533942","A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma","A Phase 2 Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP3507 (ONC206) in Adults With Recurrent Grade 2 or 3 Meningioma","Key Inclusion Criteria:\n\nAge\n\n1. Is ≥ 18 years of age at the time of signing the informed consent.\n\n   Type of Participant and Disease Characteristics\n2. Has histologically confirmed Grade 2 or 3 meningioma.\n3. Has failed, is not a candidate for, or has declined standard of care treatment for meningioma. Note: There is no limit on the number of prior systemic therapies.\n4. Has measurable disease, as assessed by the investigator. Measurable disease is defined as at least one lesion measuring ≥ 10 mm on perpendicular dimensions by contrast-enhanced MRI performed within 28 days prior to study enrollment.\n5. Has progressive disease (PD) per Response Assessment in Neuro-Oncology (RANO) criteria, as assessed by the investigator using axial, contrast-enhanced T1-weighted magnetic resonance imaging (MRI). PD is defined as an increase in size of the measurable primary lesion on imaging by at least 15% in sum of product of target lesions since last treatment or between scans separated by no more than 6 months. The presence of a new lesion would also qualify as PD.\n6. Is able to submit historic disease-related imaging from at least 9 months prior to study entry to central imaging vendor (preferably all available disease-related imaging from initial diagnosis onwards).\n7. Is able to swallow oral tablets.\n8. Has a Karnofsky Performance Status (KPS) of at least 70.\n9. Has laboratory test results meeting the following parameters within 14 days before the start of study intervention:\n\n   1. Absolute neutrophil count ≥ 1.0 × 109\u002FL and platelets ≥ 75 × 109\u002FL.\n   2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (participants with Gilbert's syndrome may be included with total bilirubin \\> 1.5 × ULN if direct bilirubin is ≤ 1.5 × ULN).\n   3. Aspartate (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. Note: For participants with documented baseline liver metastasis, the following limits will apply: ≤ 5 × ULN for transaminase.\n   4. Creatinine clearance ≥ 50 mL\u002Fmin as calculated by the Cockcroft Gault equation (or estimated glomerular filtration rate \\[eGFR\\] \\> 60 mL\u002Fmin\u002F1.73 m2) or serum creatinine ≤ 1.5 × ULN.\n10. Has an expected survival of at least 12 weeks, as predicted by the physician.\n11. Is able to submit at least 10 (preferably ≥ 15 slides, if available) unstained formalin-fixed paraffin-embedded (FFPE) slides or a tissue block with sufficient material for \\~15 slides from participant's tumor tissue to the sponsor.\n12. Has had an MRI within 28 days before the start of study intervention, with the corticosteroid dose stable or decreasing at least 5 days prior to the scan.\n\n    Sex and Contraceptive\u002FBarrier Requirements\n13. Agrees to the following based on sex assigned at birth: is not of child-bearing potential or agrees to use appropriate contraception, as defined in protocol, for males and females.\n\nKey Exclusion Criteria:\n\nMedical Conditions\n\n1. Has known hypersensitivity to JZP3507, dordaviprone, or any excipient used in the JZP3507 study intervention formulation.\n2. Has active cardiac disease\u002Fcondition as defined in the protocol.\n3. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Exceptions include participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n4. Has an active infection that requires systemic therapy.\n\n   Prior\u002FConcomitant Therapy\n5. Has received any of the following interventions within the specified time periods before the first dose of study intervention or plans to receive any of the following interventions during study participation:\n\n   1. Prior anticancer therapy or investigational agents within 28 days or 5 half-lives, whichever is shorter.\n   2. Antibody-based anticancer therapy within 42 days.\n   3. Radiotherapy within 24 weeks (\\~6 months).\n   4. Strong CYP3A4 inhibitors within 14 days.\n   5. Strong CYP3A4 inducers within 14 days.\n   6. Major surgery, open biopsy, or significant traumatic injury within 30 days.\n6. Has uncontrolled intercurrent illness or any other medical, psychiatric, or social condition that, in the opinion of the investigator, may interfere with participant safety or the ability to comply with study requirements.\n\n   Prior\u002FConcurrent Clinical Study Experience\n7. Has previous exposure to JZP3507 or dordaviprone from any source.\n\n   Diagnostic Assessments\n8. Has optic nerve sheath meningioma, extracranial meningioma, or meningioma primarily localized spinal cord.\n9. Has more than 3 measurable lesions.",{"count":62,"type":22},[25],"This study will recruit participants with Grade 2 and 3 meningiomas who have failed prior therapy. Participants will receive oral doses of JZP3507. The antitumor activity and safety of JZP3507 will be evaluated.",[28],[38,39,513,30,514,515],"JZP3507","ONC206","H3 K27me3 loss","2026-04-10",{"date":518,"type":46},"2026-04-16",{"date":496,"type":22},{"date":521,"type":22},"2031-10-16",{"name":523,"class":53},"Jazz Pharmaceuticals",5,{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":532,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":550,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":563},"100460636","phase-1-lutathera-for-treatment-of-recurrent-or-progressive-high-grade-cns-tumors-100460636","NCT05278208","Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors","Phase I\u002FII Study of Lutathera in Patients With Recurrent and\u002For Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET","All participants must meet the following inclusion and exclusion criteria. No exceptions will be given. Imaging studies to establish eligibility must be done within three weeks prior to enrollment. All other clinical evaluations to establish eligibility (except for \\[68Ga\\]Ga-DOTATATE PET) must be done within 7 days prior to enrollment.\n\n1. Screening Criteria\n\n   1.1 Diagnosis Patient must have a diagnosis of primary high-grade CNS tumor (any histopathologic diagnosis that is WHO grade III-IV) or meningioma (any histologic grade) that is recurrent, progressive, or refractory. Note that patients with DIPG (based on radiographic\u002Fclinical diagnosis) who have undergone biopsy will be eligible with histologic diagnosis of grade II-IV infiltrating glioma. All tumors must have histologic verification either at the time of diagnosis or recurrence, except for patients meningioma who have not previously undergone biopsy or resection.\n\n   Note: Refractory disease is defined as the presence of persistent abnormality on conventional MRI that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment.\n\n   1.2 Prior Therapy Patients must have recurred\u002Fprogressed following prior standard therapy for their tumor. Note: Patients with meningioma, atypical meningioma, or anaplastic meningioma must have received at least surgical resection or radiation.\n\n   1.3 Screening Consent Participant\u002Flegal guardian is willing to sign a screening consent for \\[68Ga\\]Ga-DOTATATE PET imaging. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n2. Eligibility Criteria\n\n   * Phase I Age Patient must be ≥ 4 and \\\u003C12 years of age at the time of enrollment. Disease Status: Patients who participate in the efficacy expansion cohort must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions Patients with measurable extraneural disease only are also eligible.\n   * Phase II Age Patient must be 12 to \\\u003C\u002F=39 years at the time of enrollment.\n3. Inclusion Criteria\n\n   3.1 Uptake on \\[68Ga\\]Ga-DOTATATE PET Patients must have uptake on DOTATATE PET\u002FCT in at least one tumor lesion (corresponding to known disease) equivalent to a Krenning score ≥2 (confirmed by central radiology review).\n\n   3.2 Prior Therapy Patients must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy, radiotherapy, or any other treatment modality prior to entering this study.\n\n   3.3 Chemotherapy Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosourea.\n\n   3.4 Investigational\u002FBiologic Agent\n\n   ●Biologic or investigational agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment.\n\n   For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.\n\n   ●Monoclonal Antibodies and agents with known prolonged half-lives: Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the agent ≥ 28 days prior to study enrollment.\n\n   3.5 Radiation\n\n   Patients must have had their last fraction of:\n   * Craniospinal irradiation or total body irradiation or radiation to \\> 50% of pelvis \\> 3 months prior to enrollment.\n   * Focal irradiation \\> 4 weeks prior to enrollment\n\n   3.6 Stem Cell Transplant\n\n   Patient must be:\n   * ≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease\n   * ≥ 3 months since autologous stem cell transplant prior to enrollment\n\n   3.7 Growth Factors Patients must be off all colony-forming growth factor(s) for at least 1 week prior to enrollment (e.g. filgrastim, sargramostim or erythropoietin). Two weeks must have elapsed if patients received long-acting formulations.\n\n   3.8 Somatostatin analogs Patients must be off long-acting somatostatin analogs for at least 4 weeks and off short-acting somastatin analogs (i.e., octreotide) for at least 24 hours.\n\n   3.9 Neurologic Status\n   * Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment, documented by a detailed neurological exam.\n   * Patients with seizure disorders may be enrolled if seizures are well controlled.\n\n   3.10 Performance Status Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within two weeks of enrollment must be ≥ 50. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n\n   3.11 Organ Function\n\n   Patients must have adequate organ and marrow function, both for eligibility for enrollment, and to begin each subsequent cycle of Lutathera, as defined below:\n   * Adequate Bone Marrow Function as defined as:\n\n     * Absolute neutrophil count ≥ 1.0 x 109 cells\u002F L\n     * Platelets ≥100 x 109 cells\u002F L (unsupported, defined as no platelet transfusion within 7 days)\n     * Hemoglobin ≥8 g\u002Fdl (may receive transfusions)\n   * Adequate Renal Function as defined as:\n\n     * Creatinine clearance or radioisotope GFR \\>70mL\u002Fmin\u002F1.73m2 OR\n     * A serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age\u002Fgender as follows:\n\n       1 to \\\u003C 2 years: maximum serum creatinine 0.6 mg\u002FdL for males and females. 2 to \\\u003C 6 years: maximum serum creatinine 0.8 mg\u002FdL for males and females. 6 to \\\u003C 10 years: maximum serum creatinine 1.0 mg\u002FdL for males and females. 10 to \\\u003C 13 years: maximum serum creatinine 1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 years: maximum serum creatinine 1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n       ≥ 16 years: maximum serum creatinine 1.7 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n   * Adequate Liver Function as defined as:\n\n     * Total bilirubin ≤ 3 times institutional upper limit of normal (ULN) for age\n     * AST(SGOT)\u002FALT(SGPT) ≤ 3 times institutional ULN\n     * Serum albumin ≥ 2g\u002FdL\n     * Coagulation parameters: INR \\\u003C1.5 times ULN and aPTT \\\u003C1.5 times ULN unless patients are receiving therapeutic anticoagulation which affects these parameters\n   * Adequate Cardiac Function as defined as:\n\n     * Ejection fraction of ≥ 55% by echocardiogram\n     * Serum electrolytes (Sodium, Potassium, Chloride) within institutional limits of normal (patients can be on enteral supplementation)\n\n   3.12 Corticosteroids Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment, with a maximum dexamethasone dose of 2.5mg\u002Fm2\u002Fday.\n\n   3.13 Pregnancy Status Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   3.14 Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for at least 7 months after drug cessation in females of childbearing potential and for at least 4 months after drug cessation in males of child fathering potential.\n\n   3.15 Informed Consent The patient or parent\u002Fguardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines.\n4. Exclusion Criteria\n\n   4.1 Confirmed bone marrow metastatic disease Patients with confirmed metastatic disease to bone marrow are ineligible.\n\n   4.2 Presence of bulky disease Patients with bulky disease on imaging as described below are ineligible. Treating physicians are encouraged to request a rapid central imaging review to confirm fulfillment of these criteria if there are questions or concerns.\n\n   Bulky disease is defined as:\n   * Tumor with evidence of clinically significant uncal herniation or midline shift.\n   * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR.\n   * Tumor that in the opinion of the site investigator shows significant mass effect in either the brain or spine.\n\n   Note that patients with metastatic or multi-focal disease (with exception of bone marrow) are eligible as long as no sites of disease meet above criteria for bulky disease.\n\n   4.3 Breast-feeding Nursing mothers are excluded from this study. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Lutathera.\n\n   4.4 Concurrent Illness\n   * Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient's prior malignancy has been in remission for at least 5 years from the end of treatment.\n   * Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n   * Patients with type I diabetes.\n\n   4.5 Concomitant Medications\n   * Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n   * Prior or current treatment with 177Lu-DOTATATE\u002FTOC or 90Y-DOTATATE\u002FTOC.\n\n   4.6 Prisoners will be excluded from this study.\n\n   4.7 Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits, obtain follow-up studies required to assess toxicity to therapy, or adhere to drug administration plan, other study procedures, and study restrictions.\n5. Inclusion of Women and Minorities Both males and females of all races and ethnic groups are eligible for this study.","4 Years","39 Years",{"count":535,"type":22},65,[121,25],"This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \\\u003C12 years (Phase I) or 12 to \\\u003C\u002F=39 years (Phase II) to test its safety and efficacy, respectively.\n\nFunding Source - FDA OOPD (grant number FD-R-0532-01)",[539,28,540,207,541,542,543,544,545,546,547,548,549],"High Grade Glioma","Embryonal Tumor","Anaplastic Ependymoma","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Malignant Glioma","Recurrent Medulloblastoma","Recurrent Primary Central Nervous System Neoplasm","Refractory Diffuse Intrinsic Pontine Glioma","Refractory Malignant Glioma","Refractory Medulloblastoma","Refractory Primary Central Nervous System Neoplasm",[551,552,553],"Somatostatin Receptor","DOTATATE","Lutathera","2026-04-08",{"date":556,"type":46},"2026-04-13",{"date":558,"type":46},"2022-11-21",{"date":560,"type":22},"2033-11",{"name":562,"class":86},"Nationwide Children's Hospital",4,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":4,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":4,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":570,"phases":4,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":573,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":577,"locationsCount":4},"100631231","itm11-expanded-access-program-100631231","NCT07497984","ITM11 Expanded Access Program","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","This Expanded Access Program (EAP) is intended to provide eligible participants with access to ITM-11 prior to approval by local regulatory authorities. Program availability is subject to country eligibility. The treating physician must determine, based on the individual patient´s medical history and the program eligibility criteria, whether the potential benefits outweigh the risks of treatment with an investigational therapy.",[28],"AVAILABLE","2026-03-23",{"date":576,"type":46},"2026-03-27",{"name":578,"class":53},"ITM Solucin GmbH",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":87},"100511519","phase-2-abemaciclib-in-newly-diagnosed-meningioma-patients-100511519","NCT05940493","Abemaciclib in Newly Diagnosed Meningioma Patients","A Phase 2 Multicenter, Double-blind, Randomized-controlled Study of Abemaciclib (CDK4 and 6 Inhibitor) in Newly Diagnosed RB-proficient Grade 3 Meningioma Participants","Inclusion Criteria:\n\n* Participants with newly diagnosed intracranial WHO Grade 3 meningioma; or,\n* Participants with previous lower grade meningioma and histopathologically confirmed newly transformation to Grade 3.\n* Plan to receive or have received upfront standard of care radiation therapy (RT) for the newly diagnosed WHO Grade 3 meningioma.\n* No prior treatment for Grade 3 meningioma other than surgical resection or biopsy and upfront RT. If previously diagnosed with a lower grade meningioma, no prior treatment other than surgical resection or biopsy and no prior RT.\n* Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).\n* Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative\\[s\\], and assent, if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally document and witnessed, ideally via an independent trusted witness. Participant must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.\n* Age ≥18 years at time of consent.\n* Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.\n* Ability to swallow oral medications.\n* Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):\n\n  * Adequate Bone Marrow Function: absolute neutrophil count ≥1,500\u002FmcL, platelets ≥100,000\u002FmcL, and hemoglobin ≥8.0 g\u002FdL (individual may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; initial treatment must no begin earlier than the day after any erythrocyte transfusion).\n  * Adequate Hepatic Function: total bilirubin ≤1.5x ULN (individuals with Gilbert's syndrome with a total bilirubin ≤2.0x ULN and direct bilirubin within normal limits are permitted), AST\u002FSGOT ≤3x ULN, and ALT\u002FSGPT ≤3x ULN.\n* Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.\n* For females of reproductive potential: use of highly effective contraception during study participation and for an additional 3 weeks after the end of treatment administration.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 3 weeks after the end of treatment administration.\n\nExclusion Criteria:\n\n* Prior history of cancer with ongoing treatment of disease.\n* Pregnancy or breastfeeding.\n* Known allergic reactions to components of the abemaciclib.\n* Active infection or fever \\>38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1.\n* Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis.\n* Known active systemic bacterial infection (requiring IV antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known HIV positivity or with known HBV or HCV). Screening is not required for enrollment.\n* Participant has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.\n* Prior therapy with any CDK4\u002F6 inhibitor. Prior therapy is defined as therapeutic dosing.\n* Treatment with another investigational drug within 5 half-lives of the investigational product.",{"count":587,"type":22},72,[25],"This study is being done to learn about how an investigational drug called abemaciclib works in treating patients with a newly-diagnosed grade 3 meningioma. Abemaciclib is a drug that is approved by the FDA, but not for brain tumors.\n\nParticipants who consent to the trial will have surgical tissue collected from the planned surgical resection and tested. If the tissue shows positive results for RB cells and participants are qualified, they will be enrolled and receive study treatment two to five weeks after completing standard-of-care radiation therapy.\n\nThis is a randomized clinical trial which means that participants will be randomly assigned to a treatment based on chance, like a flip of a coin. Neither the participant nor the researcher chooses the assigned group. Randomization will help the researchers study how the drug works by comparing the difference between the study drug and the placebo and how they work in treating brain tumors. This is a double-blinded study, which means that neither the participant nor the study team will know which treatment the participant is receiving.",[28],"2026-03-11",{"date":593,"type":46},"2026-03-13",{"date":595,"type":46},"2025-03-24",{"date":597,"type":22},"2030-09",{"name":599,"class":86},"Nader Sanai",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":87},"100524146","plasma-extracellular-vesicles-in-meningioma-patients-100524146","NCT06104930","Plasma Extracellular Vesicles in Meningioma Patients","Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy","MOLI","Inclusion Criteria:\n\n* confirmed meningioma (histologically or MRI\u002FDOTATOC-PET CT)\n* macroscopic tumor in MRI (either as definitive RT, or following subtotal resection or relapse)\n* indication for radiotherapy\n* completed wound healing after surgical intervention)\n* Alter ≥ 18 Jahre\n* Karnofsky Performance Score ≥ 60%\n* written informed consent\n* ability of subject to understand character and individual consequences of the trial\n* adequate contraception for women of childbearing potential\n\nExclusion Criteria:\n\n* previous or known tumor diseases \\\u003C 5 years ago\n* previous (cerebral) radiotherapy\n* simultaneous chemo\u002Fimmunotherapy\n* evidence that the patient cannot adhere to the study protocol (e.g., non-compliance)\n* the refusal of patients to participate in the study\n* participation in another clinical study or observation period in a competing trial",{"count":609,"type":22},60,[270],"While surgical resection remains the primary treatment approach for symptomatic or growing meningiomas, radiotherapy represents an auspicious alternative in patients with meningiomas not safely amenable to surgery. Biopsies are often omitted in light of potential postoperative neurological deficits, resulting in a lack of histological grading and (molecular) risk stratification. In this prospective explorative biomarker study, extracellular vesicles in the bloodstream will be investigated in patients with macroscopic meningiomas to identify a biomarker for molecular risk stratification and disease monitoring.",[28],"2026-03-06",{"date":615,"type":46},"2026-03-10",{"date":617,"type":46},"2023-11-01",{"date":619,"type":22},"2028-02-01",{"name":621,"class":86},"University Hospital Heidelberg",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":175,"enrollmentInfo":629,"targetDuration":4,"studyType":23,"phases":631,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":87},"100545090","phase-4-feasibility-of-intraoperative-tracing-of-meningioma-using-cu64dotatate-100545090","NCT06377371","Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE","A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE","Inclusion Criteria:\n\n* High suspicion of meningioma necessitating surgical resection based on conventional MRI criteria, or diagnosis of meningioma based on pathology reports from prior resection with radiographic findings of suspected recurrent or residual tumor necessitating repeat surgery.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Patients undergoing endoscopic endonasal resection, eyebrow incision surgery, or any surgical procedure in which the neoprobe cannot be employed\n* Patients with hypersensitivity to somatostatin analogs\n* Patients with contraindications to conventional MRI\n* Patients with prior history of cranial radiation therapy\n* Patients currently enrolled in other therapeutic clinical trials related to meningioma will be excluded",{"count":630,"type":22},20,[632],"PHASE4","The study team hypothesizes that it is feasible to intraoperatively detect tumor following \\[CU64\\]DOTATATE injection using the gamma probe device.",[28],"2026-02-24",{"date":637,"type":46},"2026-02-27",{"date":639,"type":46},"2024-09-11",{"date":641,"type":22},"2027-01",{"name":643,"class":86},"Weill Medical College of Cornell University",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":322,"enrollmentInfo":651,"targetDuration":4,"studyType":23,"phases":652,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":657,"leadSponsor":659,"locationsCount":87},"100385425","phase-2-direct-comparison-of-ga-68-dotatate-and-ga-68-dotatoc-100385425","NCT04298541","Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC","SSTR2-Targeted PET Imaging of Meningioma: Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC","Inclusion Criteria:\n\n* Adult patients with clinically suspected meningioma\n* Patients planned for surgery - undergoing preoperative workup\n* No contraindications to either radiotracer\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.",{"count":144,"type":22},[25],"The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET\u002FCT or PET\u002FMR and Ga-68-DOTATOC PET\u002FCT in patients with meningioma.",[28],{"date":637,"type":46},{"date":163,"type":22},{"date":658,"type":22},"2027-06",{"name":643,"class":86},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":664,"acronym":665,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":667,"enrollmentInfo":668,"targetDuration":4,"studyType":23,"phases":669,"briefSummary":670,"conditions":671,"keywords":672,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":87},"100625867","measurement-of-psma-expression-in-vivo-in-recurrent-meningiomas-by-pet-imaging-a-preliminary-study-to-a-therapeutic-trial-using-radioligand-therapy-rlt-100625867","NCT07428213","Measurement of PSMA Expression in Vivo in Recurrent Meningiomas by PET Imaging: a Preliminary Study to a Therapeutic Trial Using Radioligand Therapy (RLT)","PIVIM","Inclusion Criteria:\n\n* Adult patient (≥18 years old),\n* Beneficiary or entitled to a social security scheme\n* Patient who has agreed to participate in the study and signed written informed consent\n* Patients with histologically proven meningioma that has recurred after surgery and\u002For radiotherapy and\u002For systemic treatment\n\nExclusion Criteria:\n\n* Contraindication to \\[18F\\]PSMA PET scan: hypersensitivity to the active substance or to any of the excipients (ethanol, sodium chloride injection, and sodium ascorbate), according to the SPC sheet (https:\u002F\u002Fwww.ema.europa.eu\u002Ffr\u002Fdocuments\u002Fproduct-information\u002Fpylclari-epar-product-information\\_fr.pdf).\n* Antiangiogenic treatment within 60 days prior to inclusion\n* Impossible to follow-up for 12 months\n* Pregnant, parturient, or breastfeeding women. A pregnancy test will be performed before inclusion for women of childbearing age within 48 hours prior to the examination. -Individuals deprived of their liberty by a judicial or administrative decision\n* Individuals receiving psychiatric care\n* Individuals admitted to a health or social care facility for purposes other than research\n* Adults subject to a legal protection measure (guardianship, curatorship)\n* Subjects participating in another interventional research study that includes an exclusion period still in effect at the time of inclusion.","85 Years",{"count":480,"type":22},[270],"Meningioma is the most common intracerebral tumor in adults. Conventional treatment includes surgery and external beam radiation therapy. However, when multiple surgeries and radiation therapy sessions fail to control tumor progression, no standard treatment is adopted. Therefore, refractory multi-recurrent meningiomas remain an unmet medical need and warrant the search for new therapies.\n\nIn this respect, radioligand therapy (RLT) with LUTATHERA is used in the context of early compassionate access. RLT is based on the combination of a vector molecule directed specifically at a target (here the somatostatin receptors), with a radioactive isotope emitting particles destroying the targeted cells, and possibly their neighbors (here Lutetium 177). This treatment is indicated only if positron emission tomography (PET) imaging of somatostatin receptors is positive, excluding patients. In terms of efficacy, this treatment allows disease control in recurrences for low grade (grade 1) but has an insufficient effect in most aggressive meningiomas (grade 2, 3).\n\nRLT targeting the prostate specific membrane antigen (PSMA) prolongs the survival of patients with metastatic prostate cancer that significantly expresses PSMA, presenting a tumor signal higher than the hepatic signal in PET with PSMA ligands. PSMA is a transmembrane receptor, overexpressed in tumor cells and endothelial cells of neovascularization of various solid tumors. Initial results in immunohistochemistry (IHC) suggest that PSMA is expressed by neovascularization of meningiomas in a manner correlated with grades and recurrence. This is partly explained by the highly vascular nature of these lesions and has been iconographed by clinical cases in PSMA PET confirming in vivo an overexpression of PSMA. This overexpression of PSMA within meningiomas could offer a therapeutic alternative in RLT in patients where Lutathera is not suitable. However, there is no systematic study of the frequency and intensity of PSMA expression by PSMA ligand PET in recurrent meningiomas.\n\nThe aim of the study is to evaluate the frequency of significant in vivo PSMA expression in recurrent meningiomas via PSMA ligand PET. We consider that at least 50% of recurrent meningiomas should have a significant level of PSMA expression in PSMA ligand PET to justify a therapeutic RLT trial targeting PSMA. In addition, as an exploratory study, in the subgroup of operated patients, an IHC analysis will be performed to explore the association between the PET signal and PSMA expression and confirm the specificity of the signal.",[28],[432,673,674],"RLT","PET PSMA","2026-02-17",{"date":677,"type":46},"2026-02-23",{"date":679,"type":22},"2026-03",{"date":681,"type":22},"2028-03",{"name":683,"class":86},"Hospices Civils de Lyon"]