[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,84,0,25,[9,52,82,105,154,179,202,232,258,295,321,355,374,398,425,451,479,497,515,536,570,603,627,651,684],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100596000","early-phase-1-asciminib-with-or-without-sildenafil-for-brain-tumors-100596000",false,"NCT07039760","Asciminib With or Without Sildenafil for Brain Tumors","An Early Phase 1 Study of Asciminib With or Without Sildenafil for Brain Tumors","Inclusion Criteria:\n\n* Ages 18-39 years old, inclusive.\n* Radiographic evidence of a recurrent\u002Fprogressive brain tumor.\n* Tumor must be predominantly in an intraparenchymal location.\n* Deemed operable (able to be resected or have an open or stereotactic needle biopsy) by treating neurosurgeon.\n* ECOG Performance Status of ≥ 2. Patients who are unable to walk because of paralysis but who are up in a wheelchair will be considered ambulatory for the purposes of the performance score.\n* Bone Marrow:\n\n  * ANC (Absolute neutrophil count) ≥ 1000\u002Fµl (unsupported).\n  * Platelets ≥ 100,000\u002Fµl (may be supported by transfusion).\n  * Hemoglobin \\> 8 g\u002FdL (may be supported by transfusion).\n* Renal:\n\n  * Serum creatinine ≤ upper limit of institutional normal.\n* Hepatic:\n\n  * Bilirubin ≤ 1.5 times upper limit of normal for age.\n  * ALT (SGPT) ≤ 3 times institutional upper limit of normal for age.\n  * AST (SGOT) ≤ 3 times institutional upper limit of normal for age.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. All patients and\u002For their parents or legal guardians must sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Tumors suspected to be pituitary tumors or tumors of the meninges.\n* Tumors that are suspected of a non-CNS primary location or history of non-CNS malignancy).\n* Unable to take tablets orally\n* Pregnant and\u002For breastfeeding. Subjects of childbearing potential must have a negative serum or urine pregnancy test within 10 days prior to Day 1.\n* Active infection requiring treatment or an unexplained febrile (\\> 101.5o F) illness.\n* Known immunosuppressive disease or human immunodeficiency virus infection.\n* Any active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.\n* Any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).\n* Inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.","ALL","18 Years","39 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","Dissemination of medulloblastoma is an independent risk factor of poor prognosis. Dissemination of medulloblastoma at recurrence is nearly universally fatal. ABL1 and 2 have been recently found to mediate the dissemination of medulloblastoma. Genetically inactivating ABL1 and 2 resulted in decreased leptomeningeal medulloblastoma and improved overall survival (OS) in rodent models. ABL kinases have also been shown to play a role in the malignant properties of glioblastoma. Asciminib is an FDA approved for the treatment of chronic myeloid leukemia and is well tolerated, likely due to its specificity for ABL1 and ABL2. Asciminib is a P-glycoprotein (P-gp) substrate and thus may be susceptible to being pumped out of tumor cells and brain endothelial cells. It is unclear if asciminib can enter the central nervous system (CNS) and brain tumors in adequate concentration to have anti-tumor effects.",[28],"Brain Tumor",[30,31,32,33,34,35,36,37,38],"Asciminib","Sildenafil","ABL1","ABL2","Tyrosine kinase inhibitor","Pediatric brain tumor","Brain tumor","Pharmacokinetics","Pharmacodynamics","NOT_YET_RECRUITING","2026-06-29",{"date":42,"type":43},"2026-07-01","ACTUAL",{"date":45,"type":22},"2026-08-31",{"date":47,"type":22},"2028-03-31",{"name":49,"class":50},"Washington University School of Medicine","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100489869","cognitive-outcomes-after-brain-substructure-informed-radiation-planning-in-pediatric-patients-100489869","NCT05658731","Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients","CogRT","1. STRATUM A\n\n   1. Eligibility Criteria\n\n      * aged 1 to \\\u003C26 years of age\n      * tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit\n      * treatment must include radiation therapy (either proton or photon)\n      * patients must not have completed radiation therapy\n   2. Exclusion Criteria\n\n      * pregnancy\n      * patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological\u002Fneurodevelopmental disorders such as Down's syndrome or autism\n2. STRATUM B\n\n   1. Eligibility Criteria\n\n      * diagnosed with a brain tumor at \\\u003C26 years of age\n      * received radiation to the brain as part of therapy\n      * time from radiation start to study enrollment is ≥ 2 years\n      * there has not been disease recurrence from time of most recent radiation treatment to study enrollment\n   2. Exclusion Criteria\n\n      * patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological\u002Fneurodevelopmental disorders such as Down's syndrome or autism\n3. STRATUM C\n\n   1. Eligibility Criteria\n\n      * must be aged 5 to \\\u003C26 years of age\n      * must be able to complete research imaging without sedation\n   2. Exclusion Criteria\n\n      * must not have any major psychiatric, neurologic or medical diagnosis",true,"1 Year","26 Years",{"count":63,"type":22},338,[65],"NA","The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients.\n\nPatients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study.\n\nSurvivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed.\n\nHealthy children will also be enrolled and have research MRIs done.\n\nThe researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.",[28,68],"Head and Neck Cancer",[70,71],"radiation therapy","pediatric","RECRUITING","2026-06-26",{"date":40,"type":43},{"date":76,"type":43},"2023-05-17",{"date":78,"type":22},"2035-12",{"name":80,"class":50},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",2,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":51},"100369097","phase-1-panitumumab-irdye800-to-detect-pediatric-neoplasms-during-neurosurgical-procedures-100369097","NCT04085887","Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures","Phase 1\u002FPhase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures","Inclusion Criteria:\n\n* Subjects with suspected brain tumors 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 felt to be candidates for resection.\n* Subjects must be eligible for resection as determined by the operating surgeon.\n* Planned standard of care surgery\n* Subject age 6 months to 25 years\n* Life expectancy of more than 12 weeks\n\nExclusion Criteria:\n\n* Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment\n* History of infusion reactions to monoclonal antibody therapies\n* Pregnant or breastfeeding\n* Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)\n* Magnesium, potassium and calcium \\\u003C the lower limit of normal per institution normal lab values\n* Serum creatinine \\> 1.5 times upper reference range\n* Other lab values that in the opinion of the primary surgeon would prevent surgical resection\n* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis\n* Subjects not deemed to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here","6 Months","25 Years",{"count":21,"type":22},[93,94],"PHASE1","PHASE2","The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.",[28],{"date":98,"type":43},"2026-06-30",{"date":100,"type":22},"2026-08",{"date":102,"type":22},"2028-12",{"name":104,"class":50},"Stanford University",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":128,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":153},"100645242","phase-2-illuminate-a-clinical-study-evaluating-car-t-immune-cell-therapy-bcb-276-for-patients-with-diffuse-intrinsic-pontine-glioma-dipg-100645242","NCT07680439","Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).","A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n* Participants must be aged 1 and ≤ 26 years and weigh ≥10kg.\n* Diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) based on imaging, with or without biopsy confirmation consistent with high-grade glioma or diffuse midline glioma\n* Able to tolerate leukapheresis and other study procedures in the opinion of the Investigator.\n* Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug.\n* Participant must have completed standard radiation therapy within 6 weeks of enrollment for participation.\n* Performance Status of ≥ 60; mild to moderate restriction or better. Lansky (under 16 years of age) or Karnofsky (16 years of age or older).\n* Adequate organ function and overall clinical status to participate, including stable or improving neurologic symptoms.\n* Participants of childbearing\u002Ffathering potential must agree to use highly effective contraception from the time of enrollment through 12 months following the last T cell infusion.\n* Participants with ventriculoperitoneal (VP) shunts need to have a programable system and be able to tolerate temporary adjustment of the shunt required for study treatment.\n* Participant must meet all other health and safety criteria defined in the study protocol.\n* Participant and\u002For authorized legal representative willing to provide consent\u002Fassent for study participation, including participation in the 15-year long term follow up period.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide.\n* Evidence of metastatic disease.\n* Requirement of high or increasing doses of corticosteroids prior to participation.\n* Severe swallowing difficulties or other significant clinical conditions that may interfere with participation.\n* Presence of an active malignancy other than DIPG.\n* Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing.\n* Pregnant or breastfeeding.\n* Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.",{"count":113,"type":22},75,[94],"This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with diffuse intrinsic pontine glioma (DIPG). DIPG is a rare and aggressive brain tumor with limited treatment options. CAR T cell therapy uses a patient's own immune cells that are changed in a laboratory to recognize and attack cancer cells. The purpose of this study is to determine whether BCB-276, when given after completion of standard radiation therapy, is safe and can improve survival for patients with DIPG.\n\nTo participate, individuals must be between 1 and 26 years of age when they join the study, have a diagnosis of DIPG, and enroll for treatment within 6 weeks of completing initial radiation therapy. Participants must not have received prior anti-cancer therapy beyond radiation with or without temozolomide prior to joining this study.\n\nBCB-276 is administered intraventricularly (into the fluid around the brain), which requires placement of a catheter for treatment. BCB-276 is given every 2 weeks at a research center over a period of several months (approximately 7-8 months). Participation includes travel to a study site, procedures to support treatment administration, sample collection, and ongoing monitoring for safety and effectiveness, with follow-up visits lasting up to about 2 years.",[117,118,28,119,120,121,122,123,124,125,126,127],"Diffuse Intrinsic Pontine Glioma","DIPG","CNS Tumor","Central Nervous System Tumor","Pediatric Cancer","Adult Cancer Patients","CNS Tumor, Childhood","CNS Tumor, Adult","Brainstem Glioma","Diffuse Midline Glioma","DMG",[129,130,131,132,133,134,135,136,137,138,139,140,141,142],"BCB-276","B7-H3-specific Chimeric Antigen Receptor [CAR] T cell therapy","B7-H3","B7-H3 CAR T","B7-H3 CAR T Cells","Chimeric antigen receptor T cells","CAR T Cell","Immunotherapy","Cell Therapy","Pediatric","Children","Adolescent","Young Adult","Adult","2026-06-25",{"date":145,"type":43},"2026-07-02",{"date":147,"type":22},"2026-07",{"date":149,"type":22},"2030-07",{"name":151,"class":152},"BrainChild Bio, Inc","INDUSTRY",6,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":160,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":51},"100484445","phase-1-a-phase-iii-study-of-zotiraciclib-for-recurrent-malignant-gliomas-with-isocitrate-dehydrogenase-1-or-2-idh1-or-idh2-mutations-100484445","NCT05588141","A Phase I\u002FII Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations","* INCLUSION CRITERIA:\n* Participants must have diffuse glioma, WHO grades 2-4, histologically confirmed by Laboratory of Pathology, NCI.\n* IDH1 or IDH2 mutation status confirmed by TruSight(TM) Oncology 500 performed in LP, NCI or prior documentation of IDH1 or IDH2 mutation status\n* Participants must have received prior treatment (e.g., radiation, conventional chemotherapy, or vorasidenib) prior to disease progression.\n* Participants must have recurrent disease, proven histologically or by imaging studies\n* Participants who have undergone prior surgical resection are eligible for enrollment to cohorts 1-4.\n* Age \\>15 years\n* Karnofsky \\>70%\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>=3,000\u002Fmicroliter\n  * absolute neutrophil count (ANC) \\>=1,500\u002Fmicroliter\n  * platelets \\>100,000\u002Fmicroliter\n  * total bilirubin \\\u003C=2x ULN (ULN 1.3 mg\u002Fdl) except for participants with Gilbert Syndrome\n  * AST \\\u003C 3x ULN (ULN 34U\u002FL)\n  * ALT \\\u003C 3x ULN (ULN 55U\u002FL)\n  * serum creatinine \\\u003C 1.5 mg\u002FdL\n  * calculated creatinine clearance by CKD-EPI equation \\> 60 cc\u002Fmin\n* Participants must have recovered from the adverse effects of prior therapy to grade 2 or less (per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0)\n* Individuals of child-bearing potential (IOCBP) and men must agree to use highly effective contraception (hormonal, intrauterine device (IUD), abstinence, tube ligation, partner has had a previous vasectomy) at the study entry, for the duration of study treatment, and up to 3 months after the last dose of zotiraciclib\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 months after study treatment discontinuation\n* Participants must be scheduled for brain tumor biopsy or surgical resection at NIH (Cohort 5 only)\n* The ability of a participant, parent or legal guardian of minor participant to understand and the willingness to sign a written informed consent document. No Legally Authorized Representative can provide initial consent.\n\nEXCLUSION CRITERIA:\n\n* More than one disease relapse in those with initial diagnosis of WHO grade 3-4, or more than two disease relapses in those with initial diagnosis of WHO grade 2 for Phase II. For Phase I enrollment, there are no limits on the number of prior recurrences.\n* Prior therapy with:\n\n  * any investigational agent (including IDH mutant inhibitor) and\u002For standard of care cytotoxic therapy within 28 days prior to treatment initiation\n  * vincristine within 14 days prior to treatment initiation\n  * nitrosoureas within 42 days prior to treatment initiation\n  * procarbazine within 21 days prior to treatment initiation\n  * non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, within 7 days prior to treatment initiation\n  * surgery within 14 days prior to treatment initiation\n  * radiation therapy within 30 days prior to treatment initiation\n  * bevacizumab for tumor treatment. Note: participants who received bevacizumab for symptom management, including but not limited to cerebral edema, or pseudo progression can be enrolled\n* Prolonged QTc \\>470ms as calculated by correction formula on screening electrocardiogram (ECG) (QTCf can be used; QTCb can be used for participants with sinus bradycardia)\n* Prior invasive malignancies within the past 3 years prior to study treatment initiation (with the exception of non-melanoma skin cancers, carcinoma in situ of the cervix, melanoma in situ, or any localized cancer for whom the systemic standard of care therapy is not required)\n* History of allergic reactions attributed to compounds of similar chemical composition to zotiraciclib, such as flavopiridol\n* Pregnancy (confirmed with beta-HCG serum or urine pregnancy test performed at screening)\n* Uncontrolled intercurrent illness or social situations that would limit compliance with study requirements\n* Uncontrolled primary diabetes mellitus","15 Years",{"count":162,"type":22},96,[93,94],"Background:\n\nDiffuse gliomas are tumors that affect the brain and spinal cord. Gliomas that develop in people with certain gene mutations (IDH1 or IDH2) are especially aggressive. Better treatments are needed.\n\nObjective:\n\nTo see if a study drug (zotiraciclib) is effective in people with recurrent diffuse gliomas who have IDH1 or IDH2 mutations.\n\nEligibility:\n\nPeople aged 15 years and older with diffuse gliomas that returned after treatment. They must also have mutations in the IDH1 or IDH2 genes.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have tests of their heart function. They will have an MRI of their brain. A new biopsy may be needed if previous results are not available.\n\nZotiraciclib is a capsule taken by mouth with a glass of water. Participants will take the drug at home on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. They may also be given medications to prevent side effects of the study drug. The schedule for taking the study drug may vary for participants who will undergo surgery.\n\nParticipants will be given a medication diary for each cycle. They will write down the date and time of each dose of the study drug.\n\nParticipants will visit the clinic about once a month. They will have a physical exam, blood tests, and tests to evaluate their heart function. An MRI of the brain will be repeated every 8 weeks.\n\nParticipants may remain in the study for up to 18 cycles (1.5 years).",[28,166],"Cancer",[28,168,169,170],"Glioma","Idh Mutation","Recurrent Disease",{"date":73,"type":43},{"date":173,"type":43},"2023-05-16",{"date":175,"type":22},"2032-08-02",{"name":177,"class":178},"National Cancer Institute (NCI)","NIH",{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":51},"100593215","phase-2-a-phase-2-and-pharmacodynamic-study-of-sitagliptin-in-patients-with-progressive-grade-4-gliomas-100593215","NCT07003542","A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas","Targeting Macrophage Migration Inhibitory Factor: A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed WHO grade 4 glioma (including tumors with molecularly defined grade 4 astrocytoma) for whom a clinically-indicated tumor resection is planned.\n2. Participants must not have received sitagliptin or other gliptins.\n3. Participants must, in the opinion of the investigator be able to tolerate a pre-operative dexamethasone dose of 4 mg\u002Fd or the equivalent dose of an alternate glucocorticoid.\n4. Age \\>18 years\n5. Karnofsky performance status ≥ 60%\n6. Participants must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:\n\n   * Hemoglobin ≥ 9 g\u002Fdl\n   * Absolute neutrophil count ≥ 1,500\u002FmcL\n   * Platelet count ≥ 100,000\u002FmcL\n   * Total bilirubin \\\u003C 1.5x institutional upper limit of normal (ULN)\n   * AST (SGOT) ≤ 3x institutional ULN\n   * ALT (SGPT) ≤ 3x institutional ULN\n   * Calculated creatinine clearance \\> 50 mL\u002Fmin or creatinine \\\u003C 1.5x institutional upper limit of normal (ULN)\n   * Prothrombin time\u002Finternational normalized ratio (PT\u002FINR) \\\u003C 1.4 for participants not on warfarin.\n7. Participants on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:\n\n   * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\n   * In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin.\n8. Women of childbearing potential must have a negative pregnancy test within 21 days of study entry. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while taking part in this study, she should inform her treating physician immediately. Men of reproductive potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.\n9. Participants must be able to swallow whole tablets.\n10. Participants must have the following minimum intervals from prior treatments:\n\n    * surgery - 4 weeks\n    * nitrosoureas - 6 weeks\n    * cytotoxic chemotherapy - standard intervals depending on the most recent regimen. E.g., for temozolomide 23 days after most recent dose.\n    * For drugs not listed, the research nurse, treating investigator, and principal investigator will decide on the appropriate interval.\n    * Investigational therapy or non-cytotoxic therapy - 2 weeks.\n    * For bevacizumab - 4 weeks from expected date of protocol surgery\n11. Participants positive for human immunodeficiency virus (HIV) are allowed on study (note: HIV testing is not required), but HIV-positive participants must have:\n\n    * An undetectable viral load within 6 months of registration.\n    * A stable regimen of highly active anti-retroviral therapy (HAART)\n    * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n12. For participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Note: Known positive test for HCV ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy.\n13. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n\n    Note: A known positive test for HBV surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Participants who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g., participants immunized against hepatitis B)\n14. Patient must be deemed by investigator to be a candidate for post-operative chemotherapy.\n15. Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\n    Exclusion Criteria:\n16. Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia and neuropathy.\n17. Participants receiving any other investigational agents.\n18. History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin.\n19. Participants with uncontrolled diabetes mellitus\n20. Participants who require insulin therapy or a sulfonylurea\n21. Participants with documented history of hypoglycemia requiring medical intervention or who in the opinion of the investigator are not suitable to receive sitagliptin.\n22. Participants with 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.\n23. Other prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are excluded. Otherwise, participants with prior or concurrent malignancy are eligible.\n24. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 diarrhea of any etiology at screening) (National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events Version 5.0 \\[CTCAE v.5.0\\]).\n25. Pregnant or breastfeeding.\n26. Unable or unwilling to swallow tablets.\n27. Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness\u002Fsocial situations that would, in the investigator's judgment, make the patient inappropriate for this study.",{"count":187,"type":22},48,[94],"The purpose of this study is to evaluate whether treating glioblastoma patients with sitagliptin can improve immune response against the tumor by targeting specific immune cells called myeloid-derived suppressor cells (MDSCs) that suppress your body's natural immune response against cancer.\n\nSitagliptin is an investigational drug for this condition that works by inhibiting an enzyme called dipeptidyl peptidase 4 (DPP-4), which MDSCs rely on to enter the brain and function. While sitagliptin is FDA-approved for diabetes treatment, its use in glioblastoma is investigational (experimental).",[191,28],"Glioblastoma",[193],"Myeloid-derived suppressor cells","2026-06-24",{"date":143,"type":43},{"date":197,"type":43},"2026-03-16",{"date":199,"type":22},"2028-06",{"name":201,"class":50},"Case Comprehensive Cancer Center",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":51},"100644902","safety-and-effectiveness-evaluation-of-temozolomide-amitzo-nanoalvand-in-patients-with-grade-iii-and-iv-glioma-tumors-100644902","NCT07675070","Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors","A Phase IV and Observational Study to Evaluate Safety and Effectiveness of Temozolomide (Amitzo, NanoAlvand) Therapy in in Patients With Grade III and IV Glioma Tumors","Inclusion Criteria:\n\n* Patients with newly diagnosed grade III or IV glial tumors, or patients who have experienced disease recurrence or progression after receiving standard treatment and, based on the treating physician's diagnosis, require treatment with temozolomide\n* Patients aged 18-80 years old\n\nExclusion Criteria:\n\n* Patients without a baseline MRI\n* Patients who are unwilling to participate in the study","80 Years",{"count":211,"type":22},100,"OBSERVATIONAL","This is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Amitzo® in Iranian patients with grade III and IV glioma tumors. No control group is considered in the study design. The primary objective is to evaluate the incidence of hepatic injury in patients with grade III and IV glioma tumors, treated with Amitzo®.",[28,215,216],"Grade III Glioma","Grade IV Glioma",[218,219,220,221,168,222,223],"Brain Neoplasms","Temozolomide","Effectiveness","Safety","Amitzo","Adverse Event","2026-06-23",{"date":98,"type":43},{"date":227,"type":43},"2026-03-22",{"date":229,"type":22},"2026-11",{"name":231,"class":152},"NanoAlvand",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100463681","phase-3-blood-brain-barrier-bbb-opening-using-exablate-focused-ultrasound-with-standard-of-care-treatment-of-nsclc-brain-mets-100463681","NCT05317858","Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets","A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin","LIMITLESS","Inclusion Criteria:\n\n* Participant is ≥ 18 years of age\n* The participant provides written informed consent for the trial\n* Participant is willing to comply with all study procedures for the duration of the study\n* Participant has a Karnofsky Performance Status ≥ 70% and\u002For ECOG 0-2\n* Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s) measuring ≥ 0.5 cm in longest diameter. Target mets may include: De novo mets for which surgery and radiation can be deferred, Mets with or without history of prior radiation, Mets with history of radiation after at least 8 weeks since last radiation treatment, and In the event a previously treated met has progressed according to institutional practice within 4 weeks post radiation treatment, the met may be study eligible, and\u002For if in the opinion of the Investigator, the subject may benefit from the study procedure.\n* Female subject is not planning pregnancy during the study duration and confirmed NOT PREGNANT each procedure day.\n* Screening\u002FBaseline laboratory values Screening\u002FBaseline should adhere to local standard of care lab values for ICI therapy\n\nExclusion Criteria\n\n* Participant has evidence of acute intracranial hemorrhage\n* Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).\n* Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation.\n* Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.\n* History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement pre-surgical standard procedure to avoid increased risk of a bleeding event.\n* Participant has an infectious viral infection such as active Hepatitis B, Hepatitis C or detectable HIV viral load or participants with active bacterial infection such as TB (Bacillus tuberculosis) that may, in the opinion of the investigator, interfere with the subject receiving the study therapy or procedures or otherwise impact their participation in the trial.\n* Subjects with evidence of cranial or systemic infection.\n* Participant has received a solid organ or hematopoietic stem cell transplant.\n* Participant has received a live vaccine within 28 days prior to the first on-study ICI infusion with or without Exablate.\n* Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products.\n* Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI.\n* Subjects with significant liver dysfunction, (cirrhosis, hemochromatosis, severe alcohol abuse, or active hepatitis (autoimmune or infectious))\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first on-study ICI infusion with or without Exablate. Note: prophylactic steroid use for ICI and chemotherapy infusion per institutional practice is allowed per protocol.\n* Has a known additional malignancy that requires active treatment that would interfere with study procedures.\n* Known presence of leptomeningeal disease.\n* Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. History of (non-infectious) pneumonitis that requires steroids or has current pneumonitis\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Subject is currently enrolled in another intervention based clinical trial","100 Years",{"count":242,"type":22},30,[244],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0\u002F2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.",[28,247],"Non Small Cell Lung Cancer","2026-06-16",{"date":250,"type":43},"2026-06-18",{"date":252,"type":43},"2022-08-12",{"date":254,"type":22},"2027-12-01",{"name":256,"class":152},"InSightec",11,{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":285,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":81},"100431578","phase-2-stereotactic-brain-directed-radiation-with-or-without-aguix-gadolinium-based-nanoparticles-in-brain-metastases-100431578","NCT04899908","Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases","A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone","Inclusion Criteria:\n\n* Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:\n\n  * Melanoma with intracranial growth consistent with tumor progression despite immunotherapy\n  * Gastrointestinal primary\n  * HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and\u002For study PI)\n  * Cystic metastases\n  * Metastases ≥2cm in maximal unidimensional size\n  * Locally recurrent metastases after prior stereotactic radiation\n  * Locally recurrent metastases after prior whole brain radiation \\*Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)\n* Age ≥18 years at diagnosis of brain metastases\n* Estimated glomerular filtration rate of ≥ 60 mL\u002Fmin\u002F1.73m2\n* Karnofsky performance status of at least 70 (i.e. at minimum, \"cares for self\" but \"unable to carry on normal activity or do active work\")\n* Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and\u002For study PI\n* Ability to understand and the willingness to sign a written informed consent document\n* The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation\n\nExclusion Criteria:\n\n* Participants who cannot undergo a brain MRI\n* Participants who cannot receive gadolinium\n* Participants with widespread, definitive leptomeningeal disease\n* Patients requiring radiation to either \\>10 targets (if naïve to whole brain radiation) or \\>20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and\u002For study PI\n* Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study\n* In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either \\>6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha\u002Fbeta ratio of 2, of \\>40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique\u002Fdose\u002Ffractionation, are not eligible for the study until written approval is provided by the study\u002Fsite PI",{"count":266,"type":22},134,[94],"The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.",[270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,28],"Brain Cancer","Brain Metastases","Melanoma","Lung Cancer","Breast Cancer","HER2-positive Breast Cancer","Colorectal Cancer","Gastrointestinal Cancer","SRS","SRT","Whole Brain Radiation","Stereotactic Radiation","AGuIX","Nanoparticle","Cystic",[270,271,272,273,274,275,276,277,278,279,286,281,282,283,284,28],"Whole brain radiation",{"date":288,"type":43},"2026-06-17",{"date":290,"type":43},"2021-09-15",{"date":292,"type":22},"2029-05",{"name":294,"class":50},"Brigham and Women's Hospital",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":301,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":51},"100512022","cognitive-training-in-the-virtual-reality-setting-with-children-undergoing-radiotherapy-for-brain-tumors-100512022","NCT05947045","Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors","Inclusion Criteria:\n\n* Initiating radiotherapy for a BT\n* Between 8-22 years of age at the time of enrollment\n* English or Spanish as the primary language\n* Research participant and one parent willing to participate and provide consent\u002Fassent according to institutional guidelines\n* Participant willing to take part in required aspects of Cogmed training\n\nExclusion Criteria:\n\n* Significant impairment in global intellectual functioning (estimated or full scale IQ \\\u003C 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology \\[NOPP\\])\n* History of significant neurological disease preceding BT diagnosis including stroke or head injury with loss of consciousness\n* Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures\u002Fphotosensitive epilepsy, inadequate balance to sit or stand unassisted to complete cognitive training)\n* Psychiatric condition that would preclude or take precedence over study participation (e.g. active psychosis, suicidal ideation)\n* Need for general anesthesia during radiation therapy (note: can participate if only sedated for simulation\u002Fplanning but not daily treatment)","8 Years","22 Years",{"count":304,"type":22},45,[65],"The objective of this study is to estimate the feasibility and acceptability of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors. To achieve this goal, the investigators plan to study children undergoing radiotherapy for brain tumors randomly assigned to cognitive training administered via an iPad or virtual reality. Both groups will also participate in cognitive testing and exams using functional near infrared spectroscopy (fNIRS) pre- and post-intervention. The questions to be investigated are:\n\n1. Will cognitive training via virtual reality be feasible and acceptable for children undergoing radiotherapy for brain tumors as indicated by participation rates, adherence and frequency of side effects?\n2. Will cognitive training via virtual reality provide neurocognitive benefits?\n3. Will there be predictable changes in brain activity as measured by neuroimaging?\n\nFindings from this study will be used to develop a larger, definitive trial with direct potential to improve cognitive outcomes for children treated for cancer using a safe and effective alternative to desktop- or laptop-based computerized cognitive interventions with great promise for improving quality of life.",[28],[309,36,310,311,312],"Radiotherapy","Cognitive training","Virtual Reality","Working memory","2026-06-15",{"date":288,"type":43},{"date":316,"type":43},"2023-06-22",{"date":318,"type":22},"2027-03",{"name":320,"class":50},"St. Jude Children's Research Hospital",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":330,"briefSummary":331,"conditions":332,"keywords":341,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":351,"leadSponsor":353,"locationsCount":51},"100642991","home-based-vision-rehabilitation-guided-by-brain-imaging-100642991","NCT07635329","Home-based Vision Rehabilitation Guided by Brain Imaging","Behavioral Rehabilitation Through Image-Guided Home-based Training","BRIGHT","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Capable of providing informed consent and complying with study procedures.\n3. Unilateral or bilateral focal brain damage causing visual field loss.\n4. At least three months post-stroke or traumatic brain injury, or a stable brain tumor within the past year.\n5. Eligible for MRI based on standard safety screening.\n\nExclusion Criteria:\n\n1. Severe neurological or psychiatric conditions unrelated to the focal lesion that may interfere with study participation or data interpretation.\n2. Current or recent (within the past 6 months) drug or alcohol abuse or addiction as defined by DSM-5.\n3. Ocular disease or disorder.",{"count":211,"type":22},[65],"The BRIGHT (Behavioral Rehabilitation Through Image-Guided Home-based Training) study aims to evaluate the effectiveness of image-guided, home-based perceptual training at improving visual performance in individuals with visual field loss.\n\nUsing a prospective, crossover design, BRIGHT combines visual behavioral testing, neuroimaging, and a home-based intervention. It aims to 1) identify neural pathways that support training-induced visual plasticity; and 2) compare the efficacy of different types of visual training delivered in a home-based setting.",[333,334,335,336,337,338,339,340,28],"Visual Field Defect","Stroke","Hemianopia Homonymous","Quadrantanopia","Cortical Blindness","Visual Field Defect, Peripheral","Visual Field Loss","Traumatic Brain Injury",[342,343,344,345,346],"neuroplasticity","stroke","vision","TBI","brain tumor","2026-06-03",{"date":349,"type":43},"2026-06-09",{"date":42,"type":22},{"date":352,"type":22},"2030-03-31",{"name":354,"class":50},"Georgetown University",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":59,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":51},"100522805","convivo-endomicroscopy-100522805","NCT06087393","CONVIVO Endomicroscopy","A Feasibility Analysis of an in Vivo CONVIVO Endomicroscopy During Brain Surgery.","Inclusion Criteria:\n\n* . The patient is suffering from an intracranial lesion requiring surgery:\n* Patients undergoing neurosurgical resection for intrinsic presumably high grade, invasive tumors.\n* Patients undergoing neurosurgical resection for other brain tumors,.\n* All patient groups will only be comprised of elective surgical patients who have signed the informed consent prior to use\n\nExclusion Criteria:\n\n* History of hypersensitivity to fluorescein\n* History of allergy or bronchial asthma\n* Renal failure - Children (patients less than 18 years of age)\n* Pregnant women\n* Breast feeding women\n* Patients with inability to give informed consent",{"count":242,"type":22},[65],"Visualization of the tissue microstructure during neurosurgery using a non destructive handheld imaging technology producing a real time digital image (\"optical biopsy\") at cellular resolution is a novel method that holds great promise for optimization and improvement of the surgical treatment of brain pathologies, brain tumors in particular. The goal of this project is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.",[28],{"date":367,"type":43},"2026-06-04",{"date":369,"type":43},"2024-01-08",{"date":371,"type":22},"2026-10-12",{"name":373,"class":50},"Northwell Health",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":382,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":51},"100468118","european-prospective-investigation-into-childhood-cancer-100468118","NCT05375617","European Prospective Investigation Into Childhood Cancer","Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids)","EPICkids","Inclusion Criteria:\n\nAge: ALL and favorable biology brain tumors: Patient must be between 3 years and 21 years of age at the time of consent.\n\nDiagnosis:\n\n* ALL: Patients must have newly diagnosed B-cell ALL, T-cell ALL, or mixed phenotype acute leukemia confirmed by immunophenotyping by flow cytometry.\n* Brain tumors: Patients must have newly diagnosed favorable biology brain tumor confirmed by either pathology report, imaging and\u002For biochemical studies including low-grade gliomas, medulloblastoma, ependymoma, pituitary tumors, germ cell tumors.\n\nTreatment:\n\n* ALL and brain tumors: Participants may be children on a clinical trial or \"as per\" a clinical trial.\n* ALL: Patients will receive standard leukemia treatment.\n* Brain tumors: Patients will be treated depending upon standard approach with surgery, chemotherapy, radiation therapy. Patients receiving autologous stem cell transplantation as part of their regimen may be included.\n\nLocation: ALL and brain tumors: Patients must be receiving treatment at one of the participating centers.\n\nTiming:\n\n* ALL: Parents\u002Fguardians must consent and patient assent, if applicable, within three working days of diagnosis.\n* Brain tumors: Parents\u002Fguardians must consent and assent, if applicable, prior to initiation of chemotherapy, radiation or stem cell transplant.\n\nExclusion Criteria:\n\nALL and brain tumors:\n\n* Patients with relapsed or progressive disease, exclusive of patients with unresectable low-grade gliomas who have progressive disease.\n* Patients with history of other primary malignancy.\n* Patients with other medical conditions not associated with the malignancy that may interfere with nutritional status\u002Fgrowth and\u002For microbiome composition, like patients with Down's syndrome, metabolic disorders or celiac disease. Patients with genetic predisposition that may interfere with nutritional status\u002Fgrowth.\n\nALL:\n\n* Patient plans to receive hematopoietic stem cell transplant.\n* Mixed lineage leukemias who receive AML-based protocols. Brain tumors: Children\u002Fadolescents who will be managed by observation or surgery only, or diagnosed with ATRT or high-grade gliomas.","3 Years","21 Years",{"count":385,"type":22},1400,"Over the last decades, research has shown that poor nutritional status can adversely impact prognosis and increase toxicities during treatment for childhood cancer. EPICkids is a collaboration between the International Initiative for Pediatrics and Nutrition, the International Agency for Research on Cancer, and sites throughout three Southern European countries (Spain, Greece, and Italy). The primary aim of EPICkids is to establish an informational resource on critical nutrition parameters wherein we can describe the trajectory of nutritional status among Southern European children and adolescents with acute lymphoblastic leukemia (ALL) and favorable biology brain tumors, investigate lifestyle behaviors, sociodemographic factors, and quality of life and correlate these indicators with clinical outcomes. The specimens obtained with the proposed study will foster future studies on nutrition and prevalent childhood cancer as well as establish a framework to develop evidence-based guidelines for European children with cancer, utilizing regional, European data. We plan to recruit 900 patients with ALL and 1400 patients with a favorable biology brain tumor over five years. Nutrition parameters and lifestyle factors will be measured at systematic timepoints over the study period. Stool and blood specimens will be collected at each timepoint. Eligible patients will be between 3 and 21 years of age.",[388,28],"Acute Lymphoblastic Leukemia","2026-05-29",{"date":391,"type":43},"2026-06-02",{"date":393,"type":43},"2023-07-07",{"date":395,"type":22},"2031-03-01",{"name":397,"class":50},"Columbia University",{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":51},"100302121","phase-1-oral-capecitabine-and-temozolomide-captem-for-newly-diagnosed-gbm-100302121","NCT03213002","Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM","Phase I\u002FII Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)","CAPTEM","Inclusion Criteria:\n\n1. Be capable of giving informed consent.\n2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV\n3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide\n4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential\n5. Have a life expectancy \\> 3 months\n6. Be between the ages of 18 to 74\n7. Have a performance status KPS 70 or greater\n8. Be able to swallow pills and capsules\n9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings\n10. Have adequate bone marrow function, liver function and renal function before commencing therapy\n\nExclusion Criteria:\n\n1. Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded.\n2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.\n3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),\n4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)\n5. Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).\n6. Performance status, KPS \\\u003C 70\n7. Inability to swallow pills and capsules\n8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy\n9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine\n10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance\n11. Patients with renal insufficiency or hepatic insufficiency\n12. Patients with coagulopathies\n13. Women who are pregnant or lactating.","74 Years",{"count":408,"type":22},67,[93,94],"The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).\n\nCapecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg\u002Fm2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.",[412,191,413,414,28,415,416,166,270],"Glioblastoma Multiforme (GBM)","Glioma of Brain","Glioblastoma, Adult","Brain Tumor, Primary","Brain Tumor Adult","2026-05-28",{"date":419,"type":43},"2026-06-01",{"date":421,"type":43},"2017-06-13",{"date":423,"type":22},"2029-06",{"name":373,"class":50},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":441,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":51},"100275179","phase-1-super-selective-intra-arterial-repeated-infusion-of-cetuximab-for-the-treatment-of-newly-diagnosed-glioblastoma-100275179","NCT02861898","Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma","Phase I\u002FII Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* Male or female patients of ≥18 years of age.\n* Patients with a documented histologic diagnosis of newly diagnosed glioblastoma multiforme (GBM)\n* Patients with pathology confirmed histologic EGFR overexpression\n* Patients must have at least one confirmed and evaluable tumor site.∗\n\n  \\*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within two weeks of treatment on this research study.\n* Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.\n* No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol.\n* Patients must have adequate hematologic reserve with WBC≥3000\u002Fmm3, absolute neutrophils ≥1500\u002Fmm3 and platelets ≥100,000\u002F mm3. Patients who are on Coumadin must have a platelet count of ≥150,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5X the institutional upper limit of normal (IUNL); AST or ALT\\\u003C2.5X IUNL and creatinine\\\u003C1.5X IUNL.\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.\n* Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.\n* Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating.\n* Women of childbearing potential and fertile men will be informed as to the potential risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.\n* Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring\n* Patients with radiological evidence of leptomeningeal disease.\n* Patients with history of allergic reaction to CTX\n* Patients who initiated or completed chemo\u002FRT",{"count":433,"type":22},33,[93,94],"Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol).\n\nThis trial will be a non-randomized open label Phase I\u002FII clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.",[191,270,437,28,438,439,440],"Brain Neoplasm","Brain Neoplasm, Malignant","EGFR Gene Overexpression","GBM",[442,443,444],"EGFR","Epidermal Growth Factor Receptor","EGFRvIII",{"date":419,"type":43},{"date":447,"type":4},"2016-06",{"date":449,"type":22},"2029-12",{"name":373,"class":50},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":478},"100578155","phase-1-a-study-of-sotorasib-in-people-with-brain-tumors-100578155","NCT06807619","A Study of Sotorasib in People With Brain Tumors","BrainMet ADePPT (Anticancer Drug Penetration Platform Trial)","Inclusion Criteria:\n\n* Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection\u002Fbiopsy\n* Patients with concomitant leptomeningeal metastasis are eligible provided they have parenchymal brain neoplastic disease requiring resection\u002Fbiopsy\n* For all cohorts: no limit on prior CNS radiation or systemic therapyKPS ≥ 60\n* Life expectancy \\>12 weeks\n* Adequate treatment washout period from prior therapies to allow recovery from any prior treatment-related toxicities before enrollment in the judgment of the Investigator\n* Adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment):\n\n  * Absolute neutrophil count (ANC) ≥1.0 × 10\\^3\u002FμL (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1)\n  * Platelet count ≥10.0x10\\^4\u002FμL. Note: Participants requiring ongoing transfusions or growth factor support to maintain platelet count ≥10.0x10\\^4\u002FμL are not eligible. (Platelet transfusion is not allowed within 1 week prior to C1D1)\n  * Hemoglobin ≥ 7.0 g\u002FdL (≥ 8 g\u002FdL in gastric cancer \u002F gastroesophageal cancer indications). Note: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g\u002FdL are not eligible (Red blood cell transfusion is not allowed within 1 week prior to C1D1)\n  * Creatinine clearance ≥30 mL\u002Fmin, as calculated using the Cockcroft-Gault equation\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (\\\u003C5x ULN in participants with liver metastases)\n  * Total bilirubin ≤1.5 × ULN) if no liver metastases or \\\u003C3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to study treatment or any of the study drug excipients. For patients who are allergic to gadolinium-based agents may receive premedication as per institutional protocol or imaged without contrast at the discretion of the Principal Investigator; reactions will be managed per standard institutional protocol\n* Multiple primary malignancies within 3 years, with the exception of:\n\n  * adequately resected non-melanoma skin cancer\n  * carcinoma in situ of the cervix\n  * Smoldering pre-malignant or malignant conditions with minimal concern for CNS or extracranial progression during treatment such as CLL or MGUS based on the assessment of the treating provider\n  * curatively treated in-situ disease\n  * other solid tumors curatively treated\n  * for patients with metastatic breast cancer: contralateral breast cancer",{"count":459,"type":22},16,[93],"The researchers are doing this study to find out how effective sotorasib is at getting into KRAS G12C+ brain tumors. The researchers will also find out whether sotorasib is a safe and effective treatment for people undergoing surgical resection of KRAS G12C+ metastatic brain tumors, and do tests that show how the body absorbs, distributes, and gets rid of sotorasib.",[28],[464,465,466,467,468],"SOTORASIB","KRAS G12C","CNS-BRAIN","Advanced","24-111","2026-05-21",{"date":471,"type":43},"2026-05-22",{"date":473,"type":43},"2025-01-29",{"date":475,"type":22},"2028-01",{"name":477,"class":50},"Memorial Sloan Kettering Cancer Center",7,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":493,"leadSponsor":495,"locationsCount":51},"100610352","evaluating-biomarkers-of-cognitive-dysfunction-in-patients-with-cancer-100610352","NCT07226466","Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer","Inclusion Criteria:\n\n1. \\>= 18 years old\n2. Diagnosis of a primary brain tumor OR #3. Not both #2 and #3.\n3. Diagnosis of primary solid tumor and secondary involvement of the brain\n4. If the patient has brain metastases: fewer than 5 brain metastases (post-operative and definitive allowed), none \\> 1 cm in max diameter.\n5. Candidate for standard of care \u002F usual care (SOC) focused brain radiotherapy.\n6. No prior brain radiotherapy, including whole brain radiotherapy.\n7. Eastern Cooperative Oncology Group (ECOG) functional score 0 or 1.\n8. Estimated life expectancy post-treatment of \\> 2 years.\n\nExclusion Criteria:\n\n1. Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease).\n2. Diagnosis of memory disorder pre-treatment.\n3. Leptomeningeal disease or disease involving either hippocampus.",{"count":486,"type":22},40,"This study investigates the effects of brain radiotherapy on cognitive function by evaluating plasma biomarkers and apolipoprotein E (APOE) genotype in patients with primary or metastatic brain tumors. Standard brain radiotherapy is known to impact cognitive outcomes, yet the underlying biological mechanisms remain unclear.",[416,489,415,28],"Brain Metastases From Solid Tumors","2026-05-20",{"date":471,"type":43},{"date":42,"type":22},{"date":494,"type":22},"2028-10-31",{"name":496,"class":50},"University of California, San Francisco",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":51},"100465571","a-comprehensive-clinical-fmri-software-solution-to-enable-mapping-of-critical-functional-networks-and-cerebrovascular-reactivity-in-the-brain-100465571","NCT05342454","A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain","Inclusion criteria:\n\n1. patient must be \\>\u002F= 18 years of age;\n2. patients who will undergo neurosurgical resection of brain tumors;\n3. patients who will undergo presurgical fMRI as standard of care;\n4. patients who on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care.\n\nFor the retrospective study, we will review up to 1600 patients all clinical presurgical fMRI studies performed on brain tumor patients at the MD Anderson since 5\u002F2004.\n\nThe inclusion criteria:\n\n1. patients must be \\>\u002F= 18 years of age;\n2. patients who had the presurgical fMRI that contained at least one task-based fMRI scan.\n\nExclusion Criteria:\n\nExclusion criteria for the prospective study:\n\n1. patients cannot give informed consent;\n2. patients cannot undergo MRI examinations;\n3. patients who are indicated for speech fMRI only but cannot comply with any of the speech tasks based on the evaluation of a clinical neuropsychologist.\n\nExclusion criteria for the retrospective study:\n\n1. all fMRI scans were contaminated by head motions (translation \\> 2 mm or rotation \\> 2 degrees);\n2. only speech fMRI paradigms were performed, and patients were not able to comply with any of the speech tasks based on the evaluation of a clinical neuropsychologist.",{"count":504,"type":22},1720,"Our preliminary work demonstrates that an integrated fMRI software solution, incorporating tb-fMRI, rs-fMRI, and CVR mapping, is clinically feasible and helps clinicians plan brain tumor resection. We have developed a novel automated seed selection method that can accurately map language networks from rs-fMRI. We hypothesize that our innovative approach to enhance, optimize, and validate our preliminary software and integrate it with an established fMRI platform will create robust solutions for clinical RSN and CVR mapping. Partnering with NordicNeuroLab (NNL) will leverage the professional software development by a seasoned commercial MRI software producer in coordination with leading clinical and research experts at MD Anderson. The research will be conducted through three specific aims:\n\n1. Develop a clinical software platform for mapping RSNs and determine optimized workflow for presurgical localization of eloquent areas.\n2. Develop a clinical software platform for mapping CVR and determine optimized workflow for identifying and visualizing brain areas with potential false-negative fMRI results.\n3. Test and validate RSN and CVR mapping software in patients undergoing neurosurgery.",[28],"2026-05-18",{"date":490,"type":43},{"date":510,"type":43},"2022-05-23",{"date":512,"type":22},"2026-11-30",{"name":514,"class":50},"M.D. Anderson Cancer Center",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":51},"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",{"count":523,"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.",[526,527,28],"Meningioma of Brain","Meningioma","2026-05-15",{"date":530,"type":43},"2026-05-19",{"date":532,"type":43},"2026-01-16",{"date":534,"type":22},"2032-01-01",{"name":496,"class":50},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":23,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":51},"100567833","phase-1-brodalumab-in-the-treatment-of-immune-related-adverse-events-100567833","NCT06673329","Brodalumab in the Treatment of Immune-Related Adverse Events","Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study","Inclusion Criteria:\n\n* Ability to provide written informed consent by subject or guardian\n* Individuals \\>18 years of age\n* Diagnosis of an irAE clinically suspected to be IL-17 mediated\n* Intent-to-treat or prior treatment with systemic steroids for irAE management\n* Histology-proven primary advanced or metastatic solid organ malignancy treated with immunotherapy. Patients being treated with curative intent are not eligible to enroll.\n* Subject has a negative test for tuberculosis during screening defined as either: negative purified protein derivative (PPD) (\\\u003C 5 mm of induration at 48 to 72 hours after test is placed) OR negative QuantiFERON test. Tuberculosis testing must be performed within 30 days prior to trial initiation.\n* Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative QuantiFERON test.\n* Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate QuantiFERON test are allowed if they have all of the following: no symptoms of tuberculosis (defined as fever, shortness of breath, cough or night sweats), documented history of a completed course of adequate prophylaxis (per local standard of care), no known exposure to a case of active tuberculosis after most recent prophylaxis, no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of brodalumab.\n\nExclusion Criteria:\n\n* Estimated creatinine clearance \\\u003C 40 mg\u002Fmin\n* Active suicidal ideation or severe depression (as defined by the Diagnostic and Statistical Manual of Mental Disorders Version IV criteria (DSM-IV)) at the time of enrollment or a PHQ-9 score \\> 20\n* History of prior suicide attempts\n* PHQ-9 score greater \\>5 and \\\u003C 20 without an established mental health provider who verifies stability in their depression\n* Current or prior drug or alcohol abuse within the past 6 months (as defined by the DSM IV)\n* In the opinion of the investigator, the patient requires additional immunosuppressive treatment (other than corticosteroids and brodalumab)\n* Known hypersensitivity or contraindication to brodalumab, corticosteroids or any components of brodalumab\n* Prior treatment with brodalumab\n* Pregnancy, breastfeeding, or use of a nonreliable method of contraception\n\n  * For patients assigned female at birth: lack of willingness to use highly effective methods of birth control during treatment and for at least 4 weeks after the last dose of brodalumab (except if surgically sterile or at least 2 years postmenopausal, with postmenopausal status confirmed by Follicle-Stimulating Hormone (FSH) in the postmenopausal range).\n  * Highly effective methods of birth control include: use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Oral contraceptive pills must be supplemented by a barrier method.\n  * Patients planning to become pregnant while enrolled in the study and within 4 weeks after the last dose of brodalumab will not be permitted to enroll\n* Chronic or current severe infection requiring IV therapy\n* Evidence of active hepatitis B, C, or tuberculosis.\n* History of latent tuberculosis infection which is incompletely treated based upon local standard of care or which was never treated\n* History of or active Crohn's disease.\n* Myocardial infarction, unstable angina pectoris or stroke within the past 12 months prior to the first investigational product dose\n* Any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.\n* Any medical condition or treatment for a condition that, in the opinion of the investigator, might interfere with participation in the study or affect the reliability of clinician assessment or patient self-report\n* Other known clinically significant active medical conditions, such as:\n\n  * Severe cardiovascular disease, including advanced heart failure (American Heart Association Stage D)\n  * Aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal or greater than 3 times the upper limit of normal in patients with liver metastases measured on at least two separate occasions\n  * Direct bilirubin greater than or equal to 1.5 mg\u002FdL in patients with or without liver metastases\n  * Bone marrow insufficiency unrelated to the irAE (according to investigator judgment) with White Blood Cell (WBC) \\\u003C2000\u002Fmm3, absolute neutrophil count \\\u003C1500\u002F mm3, thrombocytopenia (platelet count) \\\u003C50,000\u002Fmm3, hemoglobin \\\u003C 8.0 g\u002FdL\n* Plan to proceed with further curative intent treatment for cancer at the time of enrollment despite the presence of irAE\n* Participation in another therapeutic clinical trial and receipt of investigational drugs within 4 weeks before the screening visit\n* Previous diagnosis of an autoimmune disease or administration of immunosuppressants in a time frame that would impede interpretation of brodalumab administration\n* Planned use of immunosuppressive agents other than steroids (including infliximab, vedolizumab, tocilizumab etc.) or administration of such agents within 28 days of trial initiation\n* Administration of live-virus vaccines within 4 weeks before the first dose of brodalumab",{"count":257,"type":22},[93],"The purpose of this study is to test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions.",[274,547,548,273,549,550,551,552,28,553,554,68,555,556,557,558,559,560],"Esophageal Cancer","Kidney Cancer","Thyroid Cancer","Gynecologic Cancer","Pancreatic Cancer","Stomach Cancer","Colon Cancer","Rectal Cancer","Oral Cancer","Liver Cancer","Skin Cancer","Prostate Cancer","Testicular Cancer","Solid Tumor","2026-05-11",{"date":563,"type":43},"2026-05-13",{"date":565,"type":43},"2025-03-11",{"date":567,"type":22},"2027-11",{"name":569,"class":50},"Brian Henick, MD",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":577,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":584,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":51},"100441061","a-study-to-measure-the-effect-of-brain-stimulation-on-hand-strength-and-function-in-patients-with-brain-tumors-100441061","NCT05023434","A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors","The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies","AWAKE CRANIOTOMY COHORT\n\nInclusion Criteria:\n\n1. Age 18 - 75\n2. Ability to understand a written informed consent document, and the willingness to sign it\n3. Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.\n4. Karnofsky performance status (KPS) ≥ 70\n5. Normal or near normal motor strength (i.e., at least 3\u002F5 in relevant areas)\n6. Normal or near normal speech (Can consistently name at least 4\u002F5 cards)\n7. Free of other illness, in the judgment of the investigator, that may shorten life expectancy\n8. Willing and able to participate in all aspects of the study\n\nExclusion Criteria:\n\n1. Presence of other malignancy not in remission\n2. Evidence of bi-hemispheric or widespread tumor involvement\n3. Medically high-risk surgical candidate\n4. History of recent scalp or systemic infection\n5. Presence of other implants or foreign bodies in the head\n6. Inability to receive an MRI for any reason\n7. Inability to receive cortical stimulation for any reason\n8. Presence of implanted cardiac device (such as a pacemaker or defibrillator)","75 Years",{"count":579,"type":22},20,[65],"The neurosurgical standard of care for treating a patient with a tumor invading hand primary motor cortex (M1) includes performing a craniotomy with intraoperative direct electrical stimulation (DES) mapping and to resect as much tumor as possible without a resultant permanent neurological deficit. However, the subjective nature of current intraoperative hand motor assessments do not offer a comprehensive understanding of how hand strength and function may be impacted by resection. Additionally, there is a paucity of data to inform how altering DES parameters may effect motor mapping. Here, the investigators seek to demonstrate a feasible, standardized protocol to quantitatively assess hand strength and function and systematically assess several stimulation parameters to improve intraoperative measurements and better understand how cortical stimulation interacts with underlying neural function.",[28,270,583],"Motor Cortex; Lesion",[585,586,587,588,589,590,591,592,593,594],"Brain Stimulation","Cortex Stimulation","Hand Motor Cortex","Primary Motor Cortex","M1","Resection","Surgery","Healthy Volunteers","Hand Strength","Hand Function","2026-05-05",{"date":561,"type":43},{"date":598,"type":43},"2023-04-17",{"date":600,"type":22},"2028-12-01",{"name":602,"class":50},"Medical College of Wisconsin",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":23,"phases":612,"briefSummary":613,"conditions":614,"keywords":615,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":626},"100416216","litt-followed-by-hypofractionated-rt-for-newly-diagnosed-gliomas-gcc-20138-100416216","NCT04699773","LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)","Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas","Inclusion Criteria:\n\n1. Patients with radiographic evidence of suggestive of a primary high-grade glioma\n2. Brain MRI with contrast demonstrates an enhancing mass within 60 days prior to registration. Patient must be deemed a candidate for LITT from MRI by Neurosurgery in order to be eligible.\n3. History and physical including neurological exam within 30 days prior to registration\n4. Karnofsky performance status ≥50% within 30 days prior to registration\n5. Age ≥ 18 years old\n6. Patients must have signed an approved informed consent\n7. Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.\n8. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.\n\nExclusion Criteria:\n\n1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation\n2. Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n\n   * History or presence of serious uncontrolled ventricular or significant arrhythmias.\n   * Any of the following within 6 months prior to registration: myocardial infarction, severe\u002Funstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism\n3. Infratentorial tumor or evidence of leptomeningeal spread\n4. Inability to undergo a MRI\n5. Pregnant or breast-feeding women",{"count":611,"type":22},32,[65],"The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas.",[168,191,28],[616,28,309,617,168],"Laser Interstitial Thermal Therapy","Proton Therapy",{"date":619,"type":43},"2026-05-06",{"date":621,"type":43},"2021-02-20",{"date":623,"type":22},"2027-12",{"name":625,"class":50},"University of Maryland, Baltimore",5,{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":634,"enrollmentInfo":635,"targetDuration":4,"studyType":23,"phases":637,"briefSummary":638,"conditions":639,"keywords":641,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":81},"100523850","development-of-mrf-for-characterization-of-brain-tumors-after-radiotherapy-100523850","NCT06101069","Development of MRF for Characterization of Brain Tumors After Radiotherapy","Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy","Inclusion Criteria for Healthy Participants:\n\n* Ages 18 - 60\n* No history of cerebrovascular disease\n* No cognitive impairments\n* Able to provide informed consent\n\nInclusion Criteria for Participants with Brain Tumors:\n\n* Biopsy-proven cases of developed recurrent tumor or radiation necrosis, OR\n* a. PET identified with developed recurrent tumor or radiation necrosis. OR\n* b. Highly suspicious case with developed recurrent tumor or radiation necrosis confirmed by tumor board, attending physician or surgeon.\n* ECOG performance status 0-2.\n* Life expectancy \\> 6 months.\n* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nInclusion Criteria for Participants with Brain Metastases or Primary Gliomas:\n\n* Radiology identified with developed primary gliomas tumor or brain metastases, OR\n* a. PET identified with developed gliomas tumor or brain metastases, OR\n* b. Highly suspicious case with developed gliomas tumor or brain metastases confirmed by tumor board\n* Participants must not have received prior radiation or surgical treatment for brain metastases or primary glioma.\n* Age: 18 years and over\n* ECOG performance status 0-2\n* Life expectancy \\> 6 months.\n* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nInclusion Criteria for Participants with Meningiomas:\n\n* Radiology identified with resectable meningioma\n* Participants have no prior radiation or surgical treatment for brain lesions\n* Age: 18 years or older\n* ECOG performance status 0-2\n* Life expectancy \\> 6 months.\n* Participants with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nExclusion Criteria:\n\n* Pregnant women OR lactating women\n* Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.\n* Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.\n* The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.\n* Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material.\n* Known history of severe claustrophobia.\n* Participants unable to lay still in the scanner for 30 minutes at a time.","60 Years",{"count":636,"type":22},90,[65],"The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, individuals with previously untreated tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study.\n\nThe primary objectives of this study are:\n\n* To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage.\n* To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.\n* To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.",[28,640,271,168],"Brain Necrosis",[642,643],"Magnetic Resonance Fingerprinting","Radiation necrosis","2026-04-29",{"date":595,"type":43},{"date":647,"type":43},"2024-10-14",{"date":649,"type":22},"2026-09",{"name":201,"class":50},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":17,"minAge":659,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":23,"phases":662,"briefSummary":663,"conditions":664,"keywords":667,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":676,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":683},"100487639","phase-2-aristocrat-blinded-trial-of-temozolomide---cannabinoids-100487639","NCT05629702","ARISTOCRAT: Blinded Trial of Temozolomide +\u002F- Cannabinoids","A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma","ARISTOCRAT","Inclusion Criteria:\n\n* Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology (repeat biopsy at recurrence is NOT required).\n* First recurrence of GBM planned for systemic treatment as determined by local Multidisciplinary Team (MDT), including agreement of a Consultant Neuro-Radiologist that imaging changes are most in keeping with recurrence and not pseudo-progression. Patients with a prior recurrence treated by surgical resection alone are eligible at time of first recurrence planned for systemic treatment.\n* Patients must have received initial first-line treatment with standard dose conventionally fractionated radiotherapy (i.e. 40 Gy in 15 fractions or 54-60 Gy in 28-33 fractions; other regimes may be considered in consultation with the ARISTOCRAT Trial Office) with concomitant and adjuvant TMZ.\n\n  * A minimum of 3 cycles of adjuvant TMZ must have been received.\n  * A minimum of Stable Disease (SD) (or Partial Response (PR)\u002FComplete Response (CR)) at the end of first-line treatment (measured by Response Assessment for Neuro-Oncology (RANO) criteria).\n* ≥3 months since day 28 of the last cycle of TMZ.\n* Karnofsky Performance Status ≥60.\n* Adequate hematologic, renal, and hepatic function within 14 days prior to randomisation:\n\n  * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n  * Platelet count ≥100 x 109\u002FL\n  * Serum creatinine clearance (measured or calculated (using local standard practice)) \\>30ml\u002Fmin\n  * Total serum bilirubin ≤1.5 x upper limit of normal (ULN)\n  * Liver transaminases \\\u003C2.5 x ULN\n* If surgery has been performed for first recurrence, then the wound must be adequately healed and there must be residual enhancing disease on MRI within 21 days of surgery or new enhancement at later follow up deemed suitable for systemic treatment.\n* Recovered from previous treatment side-effects ≤ Grade 2.\n* If on systemic steroids, must be on stable (≥7 days) or decreasing dose of steroids.\n* Willing and able to provide trial-specific informed consent.\n* Willing and able to comply with trial requirements.\n* Age ≥16.\n* Able to start treatment within 28 days of randomisation.\n\nExclusion Criteria:\n\n* Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).\n* Prior invasive malignancy (except non-melanoma skin cancer), unless disease free for a minimum of one year.\n* Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent.\n* Prior treatment, apart from debulking surgery, for first recurrence of GBM.\n* Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator.\n* Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than depression associated with their underlying glioma condition.\n* Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to TMZ treatment.\n* Current or recent cannabis or cannabinoid-based medications within 28 days of randomisation and\u002For unwilling to abstain for the duration of the trial.\n* Women who are pregnant, breastfeeding or a woman of childbearing potential who is unwilling to use effective contraceptive methods during trial treatment and for 6 months after completion of trial treatment.\n\n  o Women of childbearing age must have a negative pregnancy test within 7 days prior to randomisation.\n* Men who are sexually active and unwilling\u002Funable to use medically acceptable forms of contraception during trial treatment or for 6 months after completion of trial treatment.\n* Contra-indication to MRI or gadolinium.\n* Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.\n* Known hypersensitivity to cannabinoids or excipients of the IMP.\n* Known history of current or prior alcohol or drug dependence.\n* Known Hepatitis B (HBV), Cytomegalovirus (CMV) or opportunistic infection.\n* Has received a live vaccine within 28 days prior to randomisation.\n* Unable to administer oromucosal medication due to mucosal lesions or other issues.\n* Participation in another therapeutic clinical trial whilst taking part in this trial.\n* Any psychological, familial, sociological or geographical condition hampering protocol compliance.","16 Years",{"count":661,"type":22},120,[94],"ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide (TMZ).",[191,28,665,666],"Cannabis","Brain Tumor, Recurrent",[668,440,669,670,671,672,673,674,675],"cannabinoid","temozolomide","sativex","nabiximols","cannabis","glioblastoma","brain","recurrent",{"date":595,"type":43},{"date":678,"type":43},"2023-02-03",{"date":680,"type":22},"2027-04",{"name":682,"class":50},"University of Birmingham",22,{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":688,"acronym":4,"eligibilityCriteria":689,"healthyVolunteers":59,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":690,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":692,"conditions":693,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":81},"100387284","transgenerational-metabolic-immune-biomarkers-of-neurological-and-neurodevelopmental-disorders-100387284","NCT04322734","Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders","Inclusion Criteria (ASD):\n\n1. ASD, as defined by either a gold standard measure for ASD diagnosis, the Autism Diagnostic Observation Schedule (ADOS); the Autism Diagnostic Interview-Revised (ADI-R); and\u002For a comprehensive assessment that is consistent with ASD, in the opinion of the principal investigator. For those the PI believes a prospective diagnosis of ASD is warranted, a formal diagnostic assessment will be scheduled at screening.\n2. 0 years through 17 years 11 months of age\n\nInclusion Criteria (TD, MD, Epilepsy, Brain Tumor, Psychiatric)\n\n1\\. 0 years to 17 years 11 months of age\n\nExclusion Criteria (All):\n\n1. History of a significant adverse reaction to a prior blood draw\n2. In females of reproductive age, pregnancy or plans to become pregnant\n3. Any other historical event\u002Finformation that may, in the opinion of the PI, be a reason to exclude the child from participation.",{"count":691,"type":22},500,"The study involves up to 5 visits for a fasting blood draw, behavioral assessments, and\u002For questionnaires. Other samples may be collected when appropriate.\n\nThis study is currently recruiting.\n\nThere is no cost for visits or study-related exams.",[694,695,696,28,697,698],"Autism Spectrum Disorder","Mitochondrial Pathology","Epilepsy","Psychiatric Disorder","Mitochondrial Diseases","2026-04-22",{"date":701,"type":43},"2026-04-23",{"date":703,"type":43},"2023-12-13",{"date":705,"type":22},"2028-12-31",{"name":707,"class":50},"Southwest Autism Research & Resource Center"]