[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-metastases-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-metastases-adult":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,42,67,101,123,153,180,208,232,255,305,346,378,404,426,479,499,521,541,571,597,621,649,675,699],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100563762","phase-2-ex-vivo-drug-response-evaluation-for-next-generation-care-of-brain-metastases-100563762",false,"NCT06620380","Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases","EViDENCE-BM","Inclusion Criteria:\n\n* Patients must be 18 years or older on the day of signing the informed consent, female or male.\n* Patients must have a Karnofsky performance status of 60 or more\n* Patients must have limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.\n* Patients with a tumor with a targetable oncogenic driver mutation should have already been treated with a targeted agent and options must have been exhausted.\n* Patients must have a clinical indication for surgery for probable brain metastasis\n* Patients will be considered eligible for the study only if the diagnosis of brain metastasis has been histologically confirmed on the sample obtained during the surgery performed after signing the informed consent form for the trial.\n* Any type of primary cancer is allowed: breast cancer, lung cancer, melanoma, other cancers. Patients may have several primary cancers.\n* Patients must have adequate bone marrow, renal and hepatic function documented at screening before surgery\n* Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test\n* Patients must have the ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.\n* Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.\n\nExclusion Criteria:\n\n* Patients with rapidly progressive systemic disease\n* Patients with inability to undergo brain MRI evaluation.\n* Patients with progressive parenchymal brain metastases with an indication for requiring whole brain radiotherapy after surgery. Focal brain radiotherapy after surgery is allowed.\n* Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Intention to become pregnant during the course of the study.\n* Female who are pregnant.\n* Female who are breastfeeding and who do not agree to discontinue nursing prior to the first treatment initiated during the study.\n* Sexually active males and females of childbearing potential who are not willing to use an effective contraceptive method during the study. Male participants who do not agree not to donate sperm.","ALL","18 Years",{"count":20,"type":21},102,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Pharmacoscopy refers to an ex vivo real-time drug sensitivity profiling platform that has been shown to be of value in the treatment of leukemia (Snijder et al. 2017) (Kornauth et al. 2022) and may help to identify novel treatment opportunities for brain tumors as well (Lee et al. 2022). The rationale for pharmacoscopy-based drug sensitivity testing on real-time patient biopsies or surgery material is multiple: measuring drug response and sensitivity directly in real-time patient material, overcomes the problem of limited molecular biomarkers for established targeted therapeutic options and can identify effective drugs even for non-targeted therapies such as chemotherapy. It can also identify hitherto unknown specific vulnerabilities of cancer cells. Furthermore, testing directly on patient material overcomes the limitations of patient-derived cell cultures, organoids, and patient xenografts, as their prolonged culture times risk cellular adaptations and clonal selection that alter drug sensitivity. Pharmacoscopy maintains the tumor cell composition, including bystander cells or tumor microenvironment, and limits cell culture to max 48 hours. Furthermore, pharmacoscopy measures drug responses on a single-cell and on a high-content level, uniquely allowing to measure the drug sensitivity of tumor cells, and allowing to compare it to the drug cytotoxicity on healthy cells from the same patient. This relative readout has previously been shown to be essential for the correct prediction of a clinical response in haematological malignancies (Snijder et al. 2017) (Kornauth et al. 2022).\n\nThe aim of this study is to generate preliminary data regarding superiority of the personalized pharmacoscopy-guided approach compared to a standard non-pharmacoscopy-guided approach, in patients with brain metastases with an indication for surgery, and limited therapeutic systemic options according to the treating physician.",[27,28],"Brain Metastases","Brain Metastases, Adult","RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2025-09-12",{"date":37,"type":21},"2027-06",{"name":39,"class":40},"University of Zurich","OTHER",3,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100626606","study-comparing-neoadjuvant-versus-adjuvant-stereotactic-radiotherapy-of-brain-metastases-100626606","NCT07437820","Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases","Prospective, Randomized, Multicenter Study Comparing the Efficacy and Tolerance of Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy in the Management of Brain Metastases","NeoSRS","Inclusion Criteria:\n\n* Patients aged 18 years and older;\n* Patients with 1 to 12 brain metastases on preoperative MRI, at least one of which (contrast enhancement of at least 1 cm) is accessible for the most complete possible resection (target lesion);\n* Patients with a Karnofsky performance score of ≥ 70;\n* Patients able to perform neurocognitive tests without assistance;\n* Patients who understand the study and agree to attend all visits;\n* Patients who have signed a written informed consent form;\n* Affiliation with a social security system.\n\nExclusion Criteria:\n\n* Patient who has already been treated with surgery, radiosurgery, and\u002For radiotherapy for the target brain metastasis;\n* Medical contraindication to MRI;\n* Patient with an estimated life expectancy of ≤ 3 months;\n* Patients participating in another clinical trial, or who are in the exclusion period of another clinical trial;\n* Patients unable to complete a self-administered questionnaire;\n* Patients from a vulnerable population.",{"count":51,"type":21},68,[53],"NA","The purpose of this study is to evaluate the local control rate on the target lesion at 6, 12, and 24 months after treatment with neoadjuvant stereotactic radiotherapy (SRS NEO group) compared to standard care, adjuvant stereotactic radiotherapy (POST OP SRS group).",[28],"NOT_YET_RECRUITING","2026-06-12",{"date":59,"type":33},"2026-06-15",{"date":61,"type":21},"2026-07",{"date":63,"type":21},"2030-06-30",{"name":65,"class":40},"GCS Ramsay Santé pour l'Enseignement et la Recherche",1,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100471453","phase-2-a-study-of-stereotactic-radiosurgery-srs-for-people-with-lung-cancer-that-has-spread-to-the-brain-100471453","NCT05419076","A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain","A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Histologic diagnosis of small cell lung cancer\n* Radiographic diagnosis of up to 20 brain metastases on contrast-enhanced MRI\n* Age 18 and above\n* Performance status KPS 60-100\u002FECOG 0-2\n* Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment\n* The patient or legally authorized representative is able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to undergo contrast-enhanced MRI brain\n* Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine\n* Pregnant or lactating women\n* Prior brain-directed radiotherapy\n* Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET\u002FCT imaging, no more than 3 months before study enrollment",{"count":75,"type":21},62,[24],"The purpose of the study is to see if stereotactic radiosurgery\u002FSRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer\u002FSCLC.",[79,80,27,28,81,82],"Lung Cancer","Lung Cancer Metastatic","Small-cell Lung Cancer","Small Cell Lung Carcinoma",[84,85,86,87,88,89,90,91],"Stereotactic Radiosurgery","small cell lung cancer","small cell lung carcinoma","lung cancer","lung cancer metastatic","brain metastases","22-133","Memorial Sloan Kettering Cancer Center","2026-06-09",{"date":94,"type":33},"2026-06-10",{"date":96,"type":33},"2022-06-10",{"date":98,"type":21},"2027-06-10",{"name":91,"class":40},7,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":66},"100388846","phase-2-ucsd-image-guided-cognitive-sparing-radiosurgery-for-brain-metastases-100388846","NCT04343157","UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases","UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions","IG-SRS","Inclusion Criteria:\n\n1. Patients 18 years or older\n2. One to three brain metastases targets, all smaller than 3 cm in diameter (intact or resected tumor bed)\n3. Eastern cooperative Oncology Group (ECOG) performance status 0-2 (score of 0, no symptoms; 1, mild symptoms; 2, symptomatic, \\\u003C50% in bed during the day)\n4. Ability to answer questions and follow commands via neurocognitive testing\n5. Estimated life expectancy greater than 6 months\n6. Pathologic confirmation of extracerebral tumor site (eg, lung, breast, prostate) from either the primary site or a metastatic lesion\n7. Willingness\u002FAbility to undergo brain MRI scans\n8. Able to give informed consent\n\nExclusion Criteria:\n\n1. Pregnant or nursing women\n2. Women of childbearing potential unwilling to use adequate contraception\n3. Inability to complete a magnetic resonance imaging scan with contrast\n4. Tumor directly invading the critical area to be spared (for example a patient with tumor invading a critical white matter tract; ineligible for cognitive-sparing)\n5. Planned chemotherapy during SRS (on the day of SRS)\n6. Previous whole brain radiation therapy\n7. Leptomeningeal metastases (ineligible for SRS)\n8. Metastases from primary germ cell tumor, small cell carcinoma, or primary CNS lymphoma (ineligible for SRS)",{"count":110,"type":21},60,[24],"In this proposal, the investigators introduce advanced diffusion and volumetric imaging techniques along with innovative, automated image parcellation methods to identify critical brain regions, incorporate into cognitive-sparing SRS, and analyze biomarkers of radiation response. This work will advance the investigators' understanding of neurocognitive changes after brain SRS and help create interventions that preserve cognitive-function in brain metastases patients.",[28,114,115],"Neurocognitive Function","Cancer",{"date":94,"type":33},{"date":118,"type":33},"2019-05-01",{"date":120,"type":21},"2028-12-31",{"name":122,"class":40},"Jona Hattangadi-Gluth",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":66},"100590972","phase-2-avoiding-radiation-therapy-due-to-intracranial-response-to-chemotherapy-targeted-therapy-andor-immuno-oncology-therapy-for-brain-metastases-pilot-pragmatic-trial-100590972","NCT06974370","Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and\u002For Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial","Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and\u002For Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial (ACTION-Brain Metastases: Pilot Pragmatic Trial)","ACTION-Brain","Inclusion Criteria:\n\nPathologically (histologically or cytologically) proven diagnosis of a solid tumor malignancies within 5 years prior to registration. If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest\u002Fabdomen\u002Fpelvis, PET\u002FCT, etc.) is required. These scans are considered standard-of-care (SOC) and will not be ordered for research purposes.\n\nInitiation or planning for initiation of systemic therapy to include one or more of the following categories expected to cause an intracranial response:\n\n* Brain penetrant targeted therapies (e.g. tyrosine kinase inhibitors, multikinase inhibitors, EGFR inhibitor, ALK inhibitor, BRAF\u002FMEK inhibitor)\n* Checkpoint inhibitor immunotherapy (e.g. PDL-1 inhibitors, PD1 inhibitors, CTLA-4 inhibitors)\n* HER2 antibody-drug conjugate (e.g. TDM1, TDX-D)\n* Anti-Hormone therapies for Breast Cancer\n* Cytotoxic chemotherapy alone may be started initially, but with plan for immunotherapy or eligible targeted therapy noted above before the re-evaluation MRI head\n\nAt least 1 brain metastasis that not planned for radiation therapy or surgery.\n\nAll brain metastases not planned for resection much be ≤3 cm, with no minimum size required.\n\nSystemic therapy has started within 4 weeks of MRI brain showing new or progressive disease or plan to start systemic therapy within 4 weeks of MRI brain showing new or progressive disease.\n\nAbility to obtain MRI head scans with contrast. All MRI head scans must have slice thickness ≤1.5 mm.\n\nAge ≥ 18 years\n\nKPS \\>60\n\nAbility to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\nNo use of the planned new systemic therapy meeting 2.1.2 criteria to address brain metastases within the last 6 months.\n\nPrior radiotherapy to the active brain metastases (partial or whole brain irradiation, or prophylactic cranial irradiation \\[PCI\\])\n\nPatients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Negative urine pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n\nSerious medical comorbidities that in the opinion of the investigator would prevent participation in this study.\n\nKnown leptomeningeal disease (LMD)\n\n\\-",{"count":132,"type":21},45,[24],"This pilot pragmatic trial evaluates the feasibility of avoiding radiation therapy in patients with brain metastases who demonstrate an intracranial response to systemic therapy-including immunotherapy, targeted therapy, and\u002For chemotherapy. The study will prospectively enroll 45 patients, divided into two cohorts: 30 with non-small cell lung cancer (NSCLC) receiving immunotherapy, and 15 with brain metastases from other solid tumors. Eligible participants must have at least one brain metastasis not planned for radiation or surgery and must be initiating or planning to initiate a systemic therapy regimen expected to penetrate the blood-brain barrier and achieve intracranial activity.\n\nAll patients will undergo a re-evaluation brain MRI 4-8 weeks after initiating systemic therapy. If lesions are stable or regressing, patients will continue surveillance without radiation. If progression is noted, standard-of-care radiation may be administered at the discretion of the treating physician. The primary objective is to assess 6-month radiation therapy-free survival (RTFS) in NSCLC patients based on PD-L1 expression status. Secondary endpoints include intracranial progression-free survival, overall survival, radiation necrosis rate, and quality of life. This study seeks to inform future trial design and identify patients who may safely avoid brain radiation.",[28,136],"Brain Metastases From Non-small Cell Lung Cancer (NSCLC)",[27,138,139,140,141,142,143],"Radiation Therapy","NSCLC","Quality of Life","FACT-Br","NANO Scale","Pragmatic Trial","2026-05-20",{"date":146,"type":33},"2026-05-26",{"date":148,"type":33},"2025-06-05",{"date":150,"type":21},"2030-12",{"name":152,"class":40},"University of Vermont Medical Center",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":66},"100519787","phase-1-18f-fluciclovine-pet-amino-acid-evaluation-of-brain-metastasis-treated-with-stereotactic-radiosurgery-100519787","NCT06048094","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)","FACILITATE","Inclusion Criteria:\n\n* Diagnosis of cancer with radiographic finding of brain metastasis\n* Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension\n* Planned treatment with SRS as per the treating physician team\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET\n\nExclusion Criteria:\n\n* Prior anaphylactic reaction to 18F-fluciclovine\n* Radiographic evidence of leptomeningeal disease\n* Prior whole-brain radiation therapy\n* Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)\n* Pregnant or positive serum pregnancy test within 14 days of registration\n* Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.\n* Major medical illness or psychiatric\u002Fcognitive impairments, which in the investigator's opinion, will prevent completion of protocol and\u002For preclude informed consent\\*\n\n  * A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.",{"count":162,"type":21},46,[164],"PHASE1","This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.",[27,28,167],"Brain Cancer",[169,170,171],"stereotactic radiosurgery","18F-flucicloivine","PET imaging","2026-05-18",{"date":144,"type":33},{"date":175,"type":33},"2024-04-11",{"date":177,"type":21},"2033-05",{"name":179,"class":40},"Baptist Health South Florida",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100481131","preoperative-vs-postoperative-hypofractionated-radiosurgery-for-patients-with-large-brain-metastases-100481131","NCT05545007","Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases","Phase III Randomized Trial Comparing Preoperative Hypofractionated Radiosurgery (HSRS) to Postoperative Hypofractionated Radiosurgery (HSRS) for Patients With Large Brain Metastases (= 2.1cm) Suitable for Surgical Resection","SUPPORT","Inclusion Criteria:\n\n* Age \\>18 years\n* Histological or cytological or radiological confirmation of solid tumor malignancy\n* Clinical indication for surgical resection of one brain metastasis\n* Karnosky performance status (KPS) ≥70\n* Controlled or responsive extra cranial metastatic lesions\n* Limited brain metastases (1-4 BMs)\n* Single metastatic lesion ≥ 2.1 cm in maximum diameter (4 cm3)\n* Lesions ≤2 cm conditioning mass effect or neurological deficits or massive edema unresponsive to steroids\n* Written informed consent form\n\nExclusion Criteria:\n\n* Prior WBRT\n* KPS \\\u003C 70\n* Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease\n* Pregnant women\n* Prior open neurosurgery for malignancy\n* More than 4 brain metastases\n* Patients with incompatibility to perform MRI",{"count":189,"type":21},146,[53],"This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors suitable for surgical resection.",[28],[194,195,196,197],"pre-operative hypofractionated radiosurgery","surgical resection","large brain metastases","post-operative hypofractionated radiosurgery","2026-04-24",{"date":200,"type":33},"2026-04-30",{"date":202,"type":33},"2023-01-31",{"date":204,"type":21},"2027-01",{"name":206,"class":40},"Istituto Clinico Humanitas",9,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100623877","phase-2-tarlatamab-for-sclc-brain-metastases-100623877","NCT07402343","Tarlatamab for SCLC Brain Metastases","A Single Arm Phase II Study Evaluating Intracranial Efficacy of Tarlatamab in Patients With Asymptomatic Active Brain Metastases From Small Cell Lung Cancer","T-BRAIN","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. Signed and written informed consent\n2. Age 18 years or older\n3. Patients with pathology proven metastatic SCLC\n4. Pretreated with at least platinum-doublet chemotherapy with or without immunotherapy, no maximum of previous lines of systemic therapy\n5. WHO\u002FECOG PS 0-1\n6. Estimated life expectancy 12 weeks or more\n7. At least one asymptomatic active (newly diagnosed or unequivocally progressive) untreated brain metastasis ≥ 5mm:\n\n   1. Subjects with largest measurable intracranial lesion ≥5 mm but \\\u003C10mm may be allowed to enroll upon agreement with investigator (for patients with target lesions of ≥ 5mm but \\\u003C10 mm, 1.5 mm slice thickness brain MRI is required).\n   2. \"Untreated\" refers to the lesion not being previously treated with stereotactic radiosurgery\u002Ftherapy (SRS\u002FSRT) or surgery.\n   3. Prior treatment with whole brain radiation therapy or local surgery is permissible provided unequivocal progression in the lesion has since occurred\n8. For at least 7 days prior to study start: Patient must be asymptomatic from CNS metastases and on a stable dose of anti-epileptics and corticosteroids. Maximum dose of steroids is 10 mg prednisolone or equivalent\u002Fday, dose should be noted.\n9. Adequate organ and bone marrow function, defined as:\n\n   a. Hematological function: i. Absolute neutrophil count ≥1.5 x109\u002FL ii. Platelet count ≥ 100 x109\u002FL iii. Hemoglobin ≥ 5.6 mmol\u002Fl b. Coagulation function: i. Protrombin time (PT)\u002F international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for subjects receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to start of study treatment.\n\n   c. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Dietin Renal Disease (MDRD) calculation \\> 30 mL\u002Fmin\u002F1.73 m2 d. Hepatic function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3x ULN (or \\\u003C 5x ULN for subjects with liver metastases) ii. Total bilirubin \\\u003C 1.5x ULN (or \\\u003C 2x ULN for subjects with liver metastases), except for subjects with Gilberts disease e. Pulmonary function: i. No clinically significant pleural effusion. Pleural effusions managed with indwelling pleural catheter (eg, PleurX) are allowed.\n\nii. Baseline oxygen saturation \\> 90% on room air f. Cardiac function: i. Cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) finding\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n1. Symptomatic BM (if asymptomatic with corticosteroids with a maximum dose of steroids of 10 mg prednisolone or equivalent\u002Fday, the patient is eligible). If in doubt, discussion with the sponsor is necessary\n2. Leptomeningeal metastases (evaluated with MRI brain)\n3. BM in eloquent area (to be discussed with neuro-oncologist)\n4. Contra-indication for MRI\n5. Prior history of severe or life-threatening events from any immune-mediated therapy\n6. Grade 2 or higher toxicity from previous systemic therapy, except for alopecia\n7. History of other malignancy within the past 2 years, with the following exceptions:\n\n   1. Malignancy treated with curative intent before enrolment, with no known active disease and felt to be at low risk for recurrence by the treating physician, after discussion with the sponsor\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   3. adequately treated cervical cancer in situ without evidence of disease\n   4. adequately treated breast ductal carcinoma in situ without evidence of disease\n   5. prostatic intraepithelial neoplasia without evidence of prostate cancer\n   6. adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ\n8. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g. colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis. The following are exceptions to this criterion:\n\n   1. Subjects with vitiligo or alopecia\n   2. Subjects with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement\n   3. Any chronic skin condition that does not require systemic therapy\n   4. Subjects without active disease in the last 5 years may be included but only after consultation with the sponsor\n   5. Subjects with coeliac disease controlled by diet alone\n9. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II, appendix 2), within 6 months prior to first dose of study treatment\n10. History of arterial thrombosis (e.g. stroke or transient ischemic attack) within 6 months prior to first dose of study treatment\n11. Evidence of ILD or active, non-infectious pneumonitis\n12. History of solid organ transplant\n13. Major surgical procedures within 28 days prior to first dose of study treatment\n14. Presence of active HIV or hepatitis infection\n\n    1. HIV infection: subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of the treatment on study per local or institutional guidelines\n    2. Active hepatitis C infection (subjects with detectable hepatitis C antibody \\[HCV Ab\\] and hepatitis C virus (HCV) RNA viral load above the limit of quantification) are not allowed. Subjects with presence of HCV antibody (HCV Ab positive) and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed\n    3. Active hepatitis B infection (subjects with presence of hepatitis B surface antigen \\[HBsAg-positive\\] and hepatitis B virus (HBV) DNA viral load above the limit of quantification \\[HBV DNA positive) are not allowed. Subjects with resolved HBV infection, defined as absence of HBV surface antigen (HBsAg-negative) and presence of HBV core antibody (anti-HBc positive) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines. Subjects with inactive HBV infection inactive carrier state, defined as presence of HBV surface antigen (HBsAg-positive) and HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed with the requirement for regular monitoring for reactivation for the duration of the treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n15. Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment\n\n    a. Low-dose corticosteroids (prednisone ≤ 10 mg per day or equivalent is permitted during the study)\n16. Subjects with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of study treatment\n\n    a. Note: simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile \\> 24 hours, have no leukocytosis, nor clinical signs of an infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as exclusion criteria.\n17. Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g. non-live or non-replication agent) and live viral non-replicating vaccines (e.g. Jynneos for mpox infection) within 3 days prior to first dose of study treatment\n18. Prior therapy with any selective inhibitor of the DLL3 pathway\n19. Receiving another anticancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.\n20. Treatment in an alternative investigational trial within 28 days prior to enrollment\n21. Female subjects of childbearing potential unwilling to use protocol specified method of contraception (appendix 3) during treatment and for an additional 60 days after the last dose of tarlatamab\n22. Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab\n23. Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab\n24. Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test\n25. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab\n26. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab\n27. Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab\n28. Subject has known sensitivity to any of the products or components to be administered during dosing of tarlatamab.\n29. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n30. Subjects likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures to the best of the subject and investigators knowledge.",{"count":217,"type":21},35,[24],"A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer (SCLC).",[221,28],"Small Cell Lung Cancer","2026-04-22",{"date":224,"type":33},"2026-04-23",{"date":226,"type":21},"2026-05",{"date":228,"type":21},"2030-02",{"name":230,"class":40},"Maastricht University Medical Center",4,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":66},"100415393","phase-1-assess-use-of-18f-fluciclovine-for-patients-with-large-brain-metastases-treated-with-staged-stereotactic-radiosurgery-100415393","NCT04689048","Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery","Characterization of Large Brain Metastases With 18F-Fluciclovine PET\u002FCT Treated With Staged Stereotactic Radiosurgery","Inclusion Criteria:\n\n1. Male or female, age ≥18 years\n2. Performance status, Eastern Cooperative Oncology Group 0-2\n3. Confirmed diagnosis of brain metastases with at least one untreated lesion \\>2 cm in maximum diameter\n4. Plan for SSRS per the treating team\n5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required\n6. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography\u002Fcomputerized tomography\n\nExclusion Criteria:\n\n1. Prior anaphylactic reaction to 18F-fluciclovine\n2. Evidence of leptomeningeal disease\n3. Prior whole-brain radiation therapy\n4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)\n5. Females pregnant at the expected time of 18F-fluciclovine administration\n6. Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed\n7. Major medical illness or psychiatric\u002Fcognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and\u002For preclude informed consent",{"count":240,"type":21},20,[164],"The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.",[28,27,167],[245,89,246,247,84],"brain","brain metastases, adult","brain cancer","2026-04-20",{"date":222,"type":33},{"date":251,"type":33},"2022-04-04",{"date":253,"type":21},"2027-12",{"name":179,"class":40},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":270,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":303,"locationsCount":66},"100602997","phase-2-prophylactic-anti-seizure-medication-vs-no-anti-seizure-medication-for-patients-with-primary-motor-cortex-brain-metastases-100602997","NCT07130786","Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases","A Phase II Randomized Open-Label Trial of Levetiracetam for Prevention of Seizures in Patients With Brain Metastases in Primary Motor Cortex","Inclusion Criteria:\n\n1. Participants must have a biopsy proven solid malignancy with at least one intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis located in the primary motor cortex measuring 0.5 cm or larger in maximal unidimensional size\n2. Age of at least 18 years\n3. Karnofsky performance status of at least 60\n4. Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and\u002For study PI\n5. Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF\u002FHCC approved eConsent medium\n\nExclusion Criteria:\n\n1. Participants with prior seizures as this is a study for seizure naïve patients\n2. Participants with an allergy to levetiracetam as levetiracetam is the prophylactic anti-seizure medication under study\n3. Participants concurrently taking (i.e. at enrollment) an ASM for non-seizure indications at clinically relevant doses (gabapentin 1800 mg\u002Fday or higher, pregabalin 300 mg\u002F day or higher, lamotrigine 150 mg\u002F day or higher, valproic acid 1000 mg\u002F day or higher, topiramate 200 mg\u002F day or higher, carbamazepine 200 mg\u002F day or higher, oxcarbazepine 300 mg\u002F day or higher, primidone 100 mg\u002Fday or higher) because use of these medications could bias the study toward the null\n4. Participants who cannot tolerate a magnetic resonance imaging (MRI) study of the brain, which is required to determine the presence of and follow the course of brain metastases under study\n5. Participants who cannot receive gadolinium as MRI of the brain with contrast is required\n6. Participants with end stage renal disease due to risk of nephrogenic systemic fibrosis in this patient population after exposure to gadolinium-based contrast agents\n7. Participants with widespread, definitive leptomeningeal disease given that leptomeningeal disease and brain metastases are different entities\n8. Pregnant women are excluded from this study because levetiracetam crosses the placenta. In addition, the potential deleterious effects of gadolinium on the developing fetus are not completely known\n9. Women who are breastfeeding are excluded from this study because levetiracetam enters breast milk. In addition, the potential deleterious effects of gadolinium in breast milk remain unknown",{"count":263,"type":21},150,[24],"This is a randomized trial for patients with brain metastases in the primary motor cortex who have not had seizures to receive either the prophylactic anti-seizure medication levetiracetam (also known by its trade name Keppra) or proceed with standard of care management, which does not currently include prophylactic levetiracetam. Patients who enroll to this trial will be randomized to receive prophylactic levetiracetam or not receive prophylactic levetiracetam.",[267,268,136,28,269],"Seizures","Primary Motor Cortex","Brain Metastases From Extra-cranial Solid Tumors",[89,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296],"seizure","levetiracetam","seizure-naive","keppra","motor","primary motor cortex","motor strip","prophylaxis","Anti-Seizure Medication","ASM","SRS","SRT","necrosis","local recurrence","quality of life","focal aware","focal impaired awareness","focal to bilateral tonic clonic","generalized","focal preserved consciousness","focal impaired consciousness","FPC","FIC","FTBC","tonic","clonic","2026-03-17",{"date":299,"type":33},"2026-03-19",{"date":301,"type":33},"2025-12-23",{"date":228,"type":21},{"name":304,"class":40},"Ayal A. Aizer, MD",{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":66},"100603105","phase-2-stereotactic-radiation-for-growingchanging-brain-metastases-with-same-day-radiation-planning-and-treatment-with-margin-reduction-100603105","NCT07132190","Stereotactic Radiation for Growing\u002FChanging Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction","A Double-Blind Phase II Randomized Study of Adaptively Delivered LINAC-Based Stereotactic Radiation for Volatile Brain Metastases With Same-Day Planning and Margin Reduction","Inclusion Criteria:\n\n1. Participants must have a biopsy proven solid malignancy with at least one intact, residual or recurrent, intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis meeting one of the following criteria:\n\n   1. Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment\n   2. Abutment, to within 1.0cm, of a region of intracranial edema\n   3. Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment\n   4. Proximity (within 5.0cm) to another source of physical displacement\n2. Age of at least 18 years\n3. Karnofsky performance status of at least 60\n4. Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and\u002For study PI\n5. Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF\u002FHCC approved eConsent medium\n\nExclusion Criteria:\n\n1. Participants who cannot tolerate a brain MRI\n2. Patients who cannot receive gadolinium\n3. Participants with end stage renal disease\n4. Participants with widespread, definitive leptomeningeal disease\n5. 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 as well",{"count":110,"type":21},[24],"The goal of this study is to evaluate the feasibility and effectiveness of same-day radiation planning and treatment. The study will shorten the time interval between radiation planning (radiation mapping) and radiation treatment. The intent of this shorter time interval is to increase the likelihood that the brain metastases being treated remain fully within the high-dose radiation fields.\n\nParticipants will be randomized to receive brain-directed stereotactic radiation with a 1mm margin or 0mm margin, have their simulation\u002Fradiation planning imaging on the same day that brain-directed stereotactic radiation is delivered, and have repeat simulation\u002Fradiation planning scans during the course of treatment if more than 2-3 days have elapsed since the most recent scans.",[28,316,136,269],"Brain Tumor - Metastatic",[318,27,319,320,321,322,281,282,323,324,325,326,327,328,329,330,331,332,333,334,335,336,285,337,338,339],"Brain Mets","Brain-directed stereotactic radiation","Brain radiation","Volatile Brain Metastases","Intracranial lesion","RANO","PTV","Planning Target Volume","Local Recurrence","Radiation Necrosis","Adaptive","VMAT","Volumetric Modulated Arc Therapy","Margin","Volatile","Rapid","Growth","Shift","neurocognitive","survival","same day","randomized",{"date":299,"type":33},{"date":342,"type":33},"2025-12-30",{"date":344,"type":21},"2029-09",{"name":304,"class":40},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":353,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":356,"phases":4,"briefSummary":357,"conditions":358,"keywords":361,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":66},"100482271","developing-a-new-mri-technique-to-understand-changes-in-brain-tumors-after-treatment-100482271","NCT05559853","Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment","Development of a Clinical CEST MR Fingerprinting Method for Treatment Response Assessment in Brain Metastases","Inclusion Criteria:\n\nHealthy volunteers \\[for Study Aim 1 (SA1) and Study Aim 2 (SA2)\\] will be entered into the study if they meet the following criteria:\n\n* Age ≥ 18 years\n* Able to understand and give informed consent\n* No known cancer diagnosis\n\nPatients \\[for Study Aim 1 (SA1)\\] will be entered into the study if they meet the following criteria:\n\n* Age ≥ 18 years\n* Able to understand and give informed consent\n* At least one untreated brain metastasis \\> 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)\n\nPatients \\[for Study Aim 3 (SA3)\\] will be entered into the study if they meet the following criteria:\n\n* Age ≥ 18 years\n* Able to understand and give informed consent\n* At least one untreated brain metastasis \\> 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)\n* Planned SRS treatment\n\nExclusion Criteria:\n\nHealthy volunteers (SA1 \\& SA2) and patients (SA1 \\& SA3) exclusion criteria:\n\n* Pregnant or breastfeeding women\n* Pre-existing medical conditions, including the likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest\n* Age \\\u003C 18 years",true,{"count":355,"type":21},119,"OBSERVATIONAL","The purpose of this study is to develop and test a new magnetic resonance imaging (MRI) technique to see if it can be used to tell the difference between tumor growth from worsening of cancer and growth from the effects of treatment in participants who have brain tumors treated with radiation therapy called stereotactic radiosurgery (SRS).",[27,28,359,360],"Metastatic Brain Tumor","Metastatic Brain Cancer",[27,362,363,364,28,365,366,367,368,369,91],"Healthy Volunteers","metastatic brain tumor","metastatic brain cancer","MRI","untreated brain metastasis","CEST-MRF","chemical exchange saturation transfer magnetic resonance fingerprinting","22-191","2026-03-04",{"date":372,"type":33},"2026-03-06",{"date":374,"type":33},"2022-09-22",{"date":376,"type":21},"2027-09-22",{"name":91,"class":40},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":402,"locationsCount":66},"100377651","phase-2-brain-imaging-biomarkers-in-patients-with-brain-metastasis-100377651","NCT04197297","Brain Imaging Biomarkers in Patients With Brain Metastasis","Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiotherapy","Inclusion Criteria:\n\n* Biopsy proven primary malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)\n* At least one index lesion with diameter \\> 1cm and without imaging evidence of hemorrhage\n* Patients age \\> 18 years of age\n* Patients planned for RT to brain metastases\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Previous Whole Brain Radiotherapy\n* Previous radiosurgery to the index lesion\n* Individuals unable to undergo contrasted MRI for whatever reason",{"count":386,"type":21},90,[24],"A biomarker is a measurable indicator of the severity or presence of some disease state. In this study, brain metastases patients who will be receiving radiation treatment, will undergo CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans prior to and after radiation treatment to measure these biomarkers. This is a single-center phase II study to validate the predictive abilities of biomarkers, in terms of determining how patients will respond to radiation treatment.",[28],[138,391,392,393,394,395],"Radiotherapy","Biomarkers","Magnetic Resonance Imaging","Computed Tomography","Radiosurgery","2026-03-03",{"date":398,"type":33},"2026-03-05",{"date":400,"type":33},"2021-10-05",{"date":37,"type":21},{"name":403,"class":40},"University Health Network, Toronto",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":425},"100448805","trial-of-preoperative-radiosurgery-versus-postoperative-stereotactic-radiotherapy-for-resectable-brain-metastases-100448805","NCT05124236","Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases","A Multicenter Prospective, Interventional, Randomized Trial of Preoperative Radiosurgery Compared With Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases","PREOP-2","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Age ≥18\n4. Karnofsky performance status ≥60\n5. Histological diagnosis of a malignant primary or metastatic tumour\n6. Ability to take steroids\n7. No contraindication to magnetic resonance imaging (MRI)\n8. MRI-diagnosis of a clearly demarcated contrast-enhancing brain metastasis up to 4.0 cm diameter indicated for neurosurgical resection (tumorboard decision). Up to 3 other brain metastases suitable for primary radiosurgery\u002F stereotactic radiotherapy\n9. Survival estimated by primary clinician \\> 12 months\n10. Platelet count \\> 100\u002Fml, INR \\\u003C 1.3, Hb \\> 7.5 g\u002FdL\n\nExclusion Criteria:\n\n1. Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma\n2. \\>10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery\n3. More than 4 brain metastases or the diameter of the metastasis for resection \\>4.0 cm.\n4. More than 1 metastasis requiring resection\n5. Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated then resected with the metastasis)\n6. Prior radiation to the brain (SRS\u002FSRT to lesion to be resected and \u002For WBRT)\n7. Prior resection of a primary or secondary brain tumor\n8. Prior diagnosis of a non-meningioma brain tumor\n9. Prior radionuclide therapy within 30 days\n10. Prior anti-VEGF therapy within 6 weeks\n11. Unable to tolerate radiosurgery immobilization and treatment\n12. Inability to give informed consent\n13. Pregnancy or lactation\n14. Females of reproductive potential not willing to use effective contraception for at least 6 months after radiotherapy\n15. Males of reproductive potential not effective contraception for 3 months after radiotherapy\n16. Lack of likely compliance with protocol and follow-up",{"count":413,"type":21},200,[53],"The research question is whether a single fraction of preoperative radiosurgery can reduce the incidence of leptomeningeal disease 12 months following resection of a brain metastasis (BM) as compared with 5 fractions of postoperative stereotactic radiotherapy.",[28],"2026-03-02",{"date":370,"type":33},{"date":420,"type":33},"2022-07-29",{"date":422,"type":21},"2028-12-30",{"name":424,"class":40},"Susanne Rogers",10,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":457,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":478},"100519732","phase-1-safety-and-efficacy-of-neo212-in-patients-with-astrocytoma-idh-mutant-glioblastoma-idh-wildtype-or-brain-metastasis-100519732","NCT06047379","Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis","An Open-label Phase 1\u002F2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.","Inclusion Criteria:\n\n* Patient must be ≥ 18yrs of age.\n* Patient must have the ability to understand, and the willingness to sign, a written informed consent form.\n* Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.\n* Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.\n* If progression of disease occurs within 90 days or conformal radiation, the progression\u002Frecurrence must be outside of the radiation field or proven by biopsy\u002Fresection.\n* Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.\n* Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patient must have an expected survival or at least three months.\n* Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.\n* Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.\n* Patients must be able to comply with all study assessments.\n* If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.\n* Patient must have adequate organ and marrow function as follows:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmicroliter\n  * Platelets ≥ 100,000\u002Fmicroliter\n  * Total bilirubin within normal institutional limits\n  * AST (SGOT) \u002F ALT (SPGT) ≤ 2.5 x institutional upper limit of normal\n  * Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24- hour urine collection).\n* Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nA female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).\n* A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.\n* A serum pregnancy test will be repeated immediately if pregnancy is suspected.\n\nPhase 1: (dose escalation)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of:\n\n  * 28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent;\n  * 2 weeks from administration of immunotherapies;\n  * 28 days from administration of cytotoxic agents; and\n  * 7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine).\n\nNOTE: No washout is necessary for alternating electrical fields.\n\nPhase 2a: (safety run-in)\n\n* Patient must have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria.\n* Patient must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n\nPhase 2b: (efficacy)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria\n* Patient with select solid tumors must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n* Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria: (all Phases)\n\n* Patient in Phase 1 concurrently receiving any other antitumor therapy.\n* Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.\n* Patients with metastases to the spinal cord parenchyma.\n* Patients with metastases to the meninges.\n* Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212.\n* Patient with history of known leptomeningeal involvement.\n* Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.\n* Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and\u002For the use of concomitant medications that prolong QT\u002FQTc interval.\n* Patient had surgery within 7 days prior to the date of informed consent.\n* Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy.\n* Patient had prior treatment with perillyl alcohol.\n* Patient has a history of allergic reactions attributed to perillyl alcohol.\n* Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his\u002Fher primary CNS tumor(s).",{"count":434,"type":21},134,[164,24],"This multi-site, Phase 1\u002F2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain.\n\nThe study will have three phases, Phase 1, Phase 2a and Phase 2b.",[438,439,28,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,221,455,456],"Diffuse Astrocytoma, IDH-Mutant","Glioblastoma, IDH-wildtype","Cervical Cancer","Colorectal Cancer","Esophageal Cancer","Esophageal Squamous Cell Carcinoma","Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Head and Neck Squamous Cell Carcinoma","Melanoma","Merkel Cell Carcinoma","Microsatellite Instability-High Solid Malignant Tumor","Mismatch Repair Deficient Solid Malignant Tumor","Microsatellite Instability-High Colorectal Cancer","Mismatch Repair Deficient Colorectal Cancer","Non-small Cell Lung Cancer","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma",[458,459,460,461,27,462,463,464,465,466,467,468],"Astrocytoma","IDH-mutant","Glioblastoma","IDH-wildtype","CNS Tumor","GBM","NeOnc","Anova","NEO212","NEO100","TMZ","2026-02-27",{"date":417,"type":33},{"date":472,"type":33},"2023-11-01",{"date":474,"type":21},"2027-08-31",{"name":476,"class":477},"Neonc Technologies, Inc.","INDUSTRY",6,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":66},"100537628","multi-disciplinary-care-for-brain-metastases-100537628","NCT06280300","Multi-disciplinary Care for Brain Metastases","Intensive Multi-Disciplinary Care Initiative for Patients With Newly Diagnosed Brain Metastases","Inclusion Criteria:\n\n* Patients of all genders must be at least 18 years of age.\n* Patients must have histologically confirmed, newly diagnosed brain metastases from known or suspected solid tumor primary neoplasms.\n* Patients must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).\n* Patients must be able to complete questionnaires in English.\n* Patients must have the ability to provide informed consent.\n\nExclusion Criteria:\n\n* Patients who are \\\u003C 18 years of age are not eligible.\n* Patients who are Pregnant are not eligible.",{"count":487,"type":21},40,[53],"This is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases.",[28],"2026-01-27",{"date":493,"type":33},"2026-01-29",{"date":495,"type":33},"2023-11-16",{"date":497,"type":21},"2027-07-01",{"name":152,"class":40},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":100},"100417141","phase-1-study-of-stereotactic-radiosurgery-with-olaparib-followed-by-durvalumab-and-physicians-choice-systemic-therapy-in-subjects-with-breast-cancer-brain-metastases-100417141","NCT04711824","Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases","Phase I\u002FII Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (OLAparib) Followed by Adjuvant Combination of DuRvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With BreAst Cancer Brain Metastases","SOLARA","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Subject has histologically confirmed diagnosis of breast cancer per AJCC 8th edition meeting any of the following criteria: 1) triple negative, defined as ER\u002FPR expression \\\u003C10% and HER2-negative, with any BRCA status; or 2) HER2-negative (with ER\u002FPR expression \\>=10% with germline or somatic BRCA mutation.\n3. Subject has diagnosis of new brain metastasis by MRI, with a plan to undergo stereotactic radiosurgery (SRS) (up to 15 untreated metastases and at least 1 metastasis with maximum dimension \\> 5mm). Patients are permitted to have undergone recent craniotomy and resection of metastasis\u002Fmetastases if at least 1 other intact metastasis or gross residual tumor planned for definitive SRS is present. Patients may have had prior SRS as long as the previously treated brain metastases are stable and not planned for additional therapy. Re-irradiation of a lesion previously treated with SRS is not allowed. Discrete dural lesions are allowed.\n4. Subject may have other sites of extracranial metastatic disease (does not need to be stable, as long as no signs of impending visceral crisis).\n5. Subjects may have had prior systemic therapy other than combination DDR inhibitor (PARP inhibitor) and immune checkpoint inhibitor (i.e., prior PARP inhibitor without concurrent immune checkpoint inhibitor, or prior immune checkpoint inhibitor without concurrent PARP inhibitor, are allowed).\n6. Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 28 days prior to registration.\n7. Body weight \\>30 kg (for durvalumab monotherapy or durvalumab combination).\n8. Subject has life expectancy \\> 16 weeks.\n9. Age ≥ 18 years at the time of consent.\n10. Prior systemic cancer treatment must be completed at least 7 days prior to treatment and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline.\n11. Subject is willing and able to provide blood and tissue samples for correlative research activities, if applicable.\n12. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined in the table below:\n\n    * Platelets ≥100 x 109\u002FL\n    * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109\u002FL\n    * Hemoglobin (Hgb) ≥ 10 g\u002FdL with no blood transfusion in the past 28 days\n    * Calculated creatinine clearance ≥ 51 mL\u002Fmin\n    * Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n    * Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) ≤ 2.5 × ULN unless liver metastases are present in which case they must be ≤ 5x ULN\n    * Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) Alanine aminotransferase (ALT) ≤ 2.5 × ULN unless liver metastases are present in which case, they must be ≤ 5x ULN\n    * International Normalized Ratio (INR) or Prothrombin Time (PT)\n    * Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN; Patients taking warfarin may participate in this study; however, it is recommended that INR be monitored carefully at least once per week for the first month, then monthly if the INR is stable.\n13. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1. Postmenopausal is defined as:\n\n    * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\n    * Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50\n    * Radiation-induced oophorectomy with last menses \\> 1 year ago\n    * Chemotherapy-induced menopause with \\> 1-year interval since last menses\n    * Surgical sterilisation (bilateral oophorectomy or hysterectomy)\n14. Female patients of childbearing potential must be willing to abstain from heterosexual activity or to use 2 highly effective methods of contraception as described in the protocol from the time of informed consent until 3 months after treatment discontinuation.\n15. Male patients must be willing to abstain from heterosexual activity or use a condom during treatment and for 3 months after treatment discontinuation. See the protocol for additional information.\n16. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n17. Other inclusion criteria as specified by drug manufacturer for specific investigational drug(s), and\u002For required to specify disease status etc.\n\nExclusion Criteria:\n\n1. Subject has evidence of diffuse symptomatic leptomeningeal carcinomatosis.\n2. Subject has symptomatic brain metastases requiring immediate surgical resection within 1 week.\n3. Subject has evidence of intracranial hemorrhage or signs of impending herniation.\n4. Subject has had prior whole brain radiation therapy. Prior SRS to brain metastases is allowed as long as previously treated lesions are stable and not planned for further therapy.\n5. Subject has had prior extracranial radiation therapy within 3 weeks of study initiation unless palliative.\n6. Subject has signs of impending visceral crisis.\n7. Subject has a history of severe brain injury.\n8. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤ 7 days prior to the first dose of study drug. If sufficient wash-out time has not occurred (defined as 5 half-lives for the prior anti-cancer therapy), a longer wash-out period will be required, as agreed by sponsor-investigator and the site investigator. Concurrent use of hormonal therapy for non-cancer-related conditions is acceptable.\n9. Subject with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML\n10. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\> 470 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n11. Subject has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \\> 4 weeks and was related to the most recent treatment.\n12. Subject has a history of interstitial lung disease.\n13. Subject has a diagnosis of primary immunodeficiency.\n14. Subject must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating study therapy.\n15. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n16. Subject is pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n17. Subject is not eligible for sequential MRI or CT evaluations.\n18. Subject with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n19. Subject unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n20. Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.\n21. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n22. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n23. Participation in another clinical study with an investigational product during the last 4 weeks. NOTE: Subjects that consented to the sub-study may enroll in the primary therapeutic study if they meet all eligibility criteria outlined in Section 3.1.\n24. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. NOTE: Subjects that consented to the sub-study may enroll in the primary therapeutic study if they meet all eligibility criteria outlined in Section 3.1.\n25. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n\n    * Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the sponsor-investigator.\n    * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the sponsor-investigator.\n26. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.\n27. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational product (IP). NOTE: Resection of brain metastasis and local surgery of isolated lesions for palliative intent is acceptable.\n28. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n    * Patients with vitiligo or alopecia\n    * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n    * Any chronic skin condition that does not require systemic therapy\n    * Patients without active disease in the last 5 years may be included but only after consultation with the sponsor-investigator\n    * Patients with celiac disease controlled by diet alone\n29. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n30. History of another primary malignancy except for:\n\n    * Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n    * Adequately treated carcinoma in situ without evidence of disease.\n31. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).\n    * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent.\n    * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n    * Steroids used to treat edema from SRS as per protocol.\n32. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n33. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n34. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n35. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:\n\n    * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n    * All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n    * Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n    * Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n36. Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:\n\n    * tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice),\n    * hepatitis B (known positive HBV surface antigen (HBsAg) result),\n    * hepatitis C, or\n    * human immunodeficiency virus (positive HIV 1\u002F2 antibodies).\n\nNOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with HIV\u002FAIDS with adequate antiviral therapy to control viral load would be allowed if they are stable and have been on treatment for ≥ 4 weeks prior to first dose of study drug(s). Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy. Testing not required.\n\nEligibility Criteria for surgical sub-study\n\nInclusion Criteria\n\nSubjects planned for surgical resection of their brain metastasis must meet the following criteria:\n\n1. Subject is planned for surgical resection of their brain metastasis. NOTE: subjects with acutely symptomatic brain metastasis requiring surgical resection within 1 week are not eligible for the sub-study.\n2. Subject meets inclusion criteria #1, 2, 4, 6, 8-16 above.1 Female patients of child-bearing potential and male patients must be willing to abstain from heterosexual intercourse or use contraception as described in protocol.\n\nExclusion Criteria\n\nSubjects meeting any of the criteria below may not participate in the surgical sub-study:\n\n1. Subject has acutely symptomatic brain metastasis requiring surgical resection within 1 week.\n2. Subject meets criteria #1, 2, 4, 7-17, 20-25, 27-28, 30, 33-34 above from section.",{"count":508,"type":21},41,[164,24],"This study is a Phase I\u002FII study evaluating the safety and effectiveness of focused radiation therapy (radiosurgery) together with olaparib, followed by immunotherapy, for patients with brain metastases from triple negative or BRCA-mutated breast cancers.\n\nThis study will have a Phase I portion in which subjects will be enrolled based on 3+3 dose escalation rules. Three dose levels of olaparib will be studied.\n\nCycle 1 of study treatment will consist of Olaparib given twice daily concurrently with stereotactic radiosurgery (SRS). Olaparib will start one week prior to SRS and continue during and following SRS (1-5 fractions) for up to 28 days total. The number of doses of Olaparib will be dependent on how long it takes a subject to recover from SRS (ideally the subject will be off steroids, if they are required, at the start of Cycle 2, with exceptions outlined later in this section).\n\nOnce the subject has recovered from SRS (based on investigator discretion) that will be considered the DLT period. Cycle 2 will be initiated with physician's choice systemic therapy and durvalumab. Cycle 2+ will equal 21 days. During Cycles 2 and 3, physician's choice systemic monotherapy will be given along with durvalumab per protocol. Each cycle will last 21 days. Imaging to evaluate intracranial and extracranial disease will be performed after Cycle 3, and subjects with response will continue with the systemic therapy and durvalumab until progression (intracranial or extracranial), unacceptable toxicity or death.",[512,28],"Breast Cancer","2025-12-22",{"date":301,"type":33},{"date":516,"type":33},"2022-03-09",{"date":518,"type":21},"2026-11",{"name":520,"class":40},"Colette Shen",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":356,"phases":4,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":66},"100476185","circulating-biomarkers-repository-in-adults-diagnosed-with-primary-and-metastatic-brain-tumors-100476185","NCT05480644","Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors","Inclusion Criteria:\n\n* Have a confirmed diagnosis of primary or metastatic brain tumor (histology or imaging as appropriate)\n\nExclusion Criteria:\n\n* None",{"count":528,"type":21},300,"The purpose of this protocol is to create a repository of blood samples from patients diagnosed with primary and metastatic brain tumors who are being seen in the Department of Radiation Oncology at Duke Cancer Center.",[531,28],"Brain Tumor, Primary","2025-11-18",{"date":534,"type":33},"2025-11-19",{"date":536,"type":33},"2022-12-01",{"date":538,"type":21},"2032-12",{"name":540,"class":40},"Duke University",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":548,"enrollmentInfo":549,"targetDuration":4,"studyType":356,"phases":4,"briefSummary":551,"conditions":552,"keywords":556,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":568,"locationsCount":570},"100608184","ai-assisted-diagnosis-of-malignant-brain-tumors-100608184","NCT07198256","AI-assisted Diagnosis of Malignant Brain Tumors","Research on AI-assisted Diagnosis of Common Malignant Brain Tumors Based on Magnetic Resonance Imaging","Inclusion Criteria:\n\n* Patients diagnosed with glioma, brain metastases, and brain lymphoma by pathology, with the patient being at least 18 years old; preoperative MRI was complete.\n\nExclusion Criteria:\n\n* Poor image quality; history of previous brain surgery or radiotherapy; accompanied by other intracranial lesions.","100 Years",{"count":550,"type":21},3000,"This study aims to establish a large-scale, multi-center MRI database for malignant brain tumors. It will develop an artificial intelligence system for the segmentation and classification of multiple subtypes of brain tumors (including glioma, metastatic tumor and lymphoma et al.) using deep learning technology. This will address the issues of small sample sizes and limited classification performance in existing methods, thereby improving the accuracy of non-invasive preoperative diagnosis, reducing the need for biopsies, and having significant clinical translational value.",[553,28,554,555],"Gliomas","Lymphoma","Brain Tumor Adult",[557,558,89,559,560,561],"brain tumor","glioma","lymphoma","magnetic resonance imaging","artificial intelligence","2025-09-22",{"date":564,"type":33},"2025-09-30",{"date":566,"type":33},"2025-09-01",{"date":120,"type":21},{"name":569,"class":40},"Second Affiliated Hospital, School of Medicine, Zhejiang University",2,{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":356,"phases":4,"briefSummary":580,"conditions":581,"keywords":587,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":66},"100550662","comparison-of-molecular-genetic-concordance-of-the-primary-tumor-and-brain-metastases-of-colorectal-cancer-100550662","NCT06449989","Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer","GENCONCOR-1","Inclusion Criteria:\n\n1. Men and women over 18 years of age.\n2. Histologically confirmed cancer of the colon or rectum.\n3. Histologically confirmed metastatic lesion of the brain.\n4. Neurosurgical resection for brain metastases of colorectal cancer.\n5. Presence of paired tumor samples (both primary tumor and intracranial material).\n\nExclusion Criteria:\n\n1. Missing one sample from a pair of tumor samples.\n2. Low quality or lack of tumor material for molecular genetic research.",{"count":579,"type":21},30,"GENCONCOR-1 study is translational research aimed to investigate the concordance of the molecular genetic profile of the primary tumor and brain metastases (BM) of colorectal cancer (CRC). The study was conducted by post hoc analysis of pairs of samples of histological material with determination of the mutational status of genes KRAS, NRAS, BRAF, HER2 and MSI.",[582,28,583,584,585,586],"Colorectal Cancer Metastatic","Ras (KRAS or NRAS) Gene Mutation","BRAF Gene Mutation","HER2 Gene Mutation","MSI",[582,28,583,584,585,586],"2025-08-07",{"date":590,"type":33},"2025-08-12",{"date":592,"type":33},"2024-04-01",{"date":594,"type":21},"2027-09",{"name":596,"class":40},"Blokhin's Russian Cancer Research Center",{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":22,"phases":605,"briefSummary":606,"conditions":607,"keywords":609,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":41},"100546965","phase-2-sacituzumab-govitecan-and-bevacizumab-for-nsclc-brain-metastases-100546965","NCT06401824","Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases","A Single Arm Phase II Study Evaluating Intracranial Efficacy of Sacituzumab Govitecan (SG) With Bevacizumab in Patients With Active, Asymptomatic Brain Metastases From Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n  1. Signed informed consent must be obtained prior to participation in the study.\n  2. Participant is an adult ≥ 18 years of age at the time of informed consent.\n  3. ECOG performance status ≤1.\n  4. Estimated life expectancy of 12 weeks or more.\n  5. Pathology proven metastatic non-squamous NSCLC\n  6. For those without an actionable oncogenic driver: progression on immunotherapy and\u002For platinum-doublet chemotherapy (concurrent or sequential, in any order). If contra-indication for immunotherapy: progression on platinum-doublet chemotherapy.\n  7. For those with an actionable oncogenic driver: progression on targeted therapy and platinum-doublet chemotherapy. For the latter group, previous ICI is allowed but not mandatory.\n  8. BM not in eloquent area (all patients have at least to be discussed with a neurologist, and preferably they are discussed in the local neuro-oncology MDT).\n  9. Maximum BM size 2 cm in longest diameter (for each BM).\n  10. At least one untreated brain metastasis ≥ 5mm:\n\n      1. Patients with largest measurable intracranial lesion ≥5 mm but \\\u003C10 mm may be allowed to enroll upon agreement with the principal investigator (for patients with target lesions of ≥ 5mm but \\\u003C10 mm, 1.5 mm slice thickness brain MRI is required).\n      2. Prior local treatment is permissible provided unequivocal progression in the lesion has since occurred (discussed in neuro-oncology MDT) or if new lesions have occurred.\n      3. For at least 7 days prior to first dose of SG and bevacizumab in this study: Patient must be asymptomatic from CNS metastases and on a stable dose of corticosteroids, with a maximum of 4 mg dexamethasone\u002Fday. Anti-epileptic dose should also be stable for 7 days.\n  11. Participant must have recovered from all toxicities related to prior treatments to grade ≤ 1 (CTCAE v 5.0). Exception to this criterion are alopecia and neuropathy of any grades.\n  12. Adequate organ function including the following laboratory values at the screening visit:\n\n      * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (without growth factor support),\n      * Platelets ≥ 100 x 109\u002FL (without growth factor support),\n      * Hemoglobin (Hb) ≥ 6 mmol\u002Fl (= 9 g\u002Fdl) (7 days without transfusions or growth factor support),\n      * Aspartate transaminase (AST) ≤ 2.5 x ULN, or ≤ 5 × ULN if known liver metastases\n      * Alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 × ULN if known liver metastases\n      * Serum albumin \\> 3 g\u002FdL\n      * Total bilirubin ≤ 1.5 ULN,\n      * Creatinine clearance ≥ 30 mL\u002Fmin by calculation using Cockcroft-Gault formula or based on 24-hour urine sample assessment.\n  13. Participant is capable of following instructions regarding study treatment administration, and must be able to communicate with the Investigator and comply with the requirements of the study procedures.\n  14. Negative serum or urine pregnancy test within 7 days prior to study treatment in women with childbearing potential. Patient must be willing to use effective methods of contraception. Female patients must be postmenopausal, surgically sterile, or they must agree to use a physical barrier method of contraception in addition to either an intrauterine device or hormonal contraception until at least 4 months after termination of study drug.\n\nExclusion Criteria:\n\n* A potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Leptomeningeal metastasis (based on MRI or CSF cytology, if strong suspicion despite negative MRI, CSF analysis should be done).\n  2. Previous treatment with TROP2 inhibitor or angiogenesis inhibitor.\n  3. Known hypersensitivity to the study drugs, its metabolites, or formulation excipient.\n  4. Positive serum pregnancy test or women who are breastfeeding.\n  5. Contra-indication for MRI.\n  6. History of allogeneic bone marrow or solid organ transplant.\n  7. Have had a prior anticancer biologic agent (ADC, ICI) within 4 weeks prior to enrolment or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrolment and have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry.\n\n     a. Note: Patients participating in observational studies are eligible.\n  8. Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent.\n\n     1. Note: patients with any grade vitiligo or alopecia are an exception to this criterion and will qualify for the study.\n     2. Note: if patients received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n  9. Have an active second malignancy. Note: patients with a history of malignancy that has been treated completely, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumours with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n  10. Met any of the following criteria for cardiac disease:\n\n      1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment.\n      2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.\n      3. New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of \\\u003C 40%.\n  11. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrolment.\n  12. Have active serious infection requiring antibiotics.\n  13. Have known history of HIV-1 or 2 (or positive HIV-1\u002F2 antibody, if done at screening) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.\n  14. Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.\n  15. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n  16. Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study\n  17. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.\n  18. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary embolism within 1 months of enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, uncontrolled pleural effusion, etc.); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc.); or prior pneumonectomy.\n  19. Contra-indications specific to bevacizumab\n\n      1. Inadequately controlled hypertension (defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg). Anti-hypertensive therapy to achieve these parameters is allowable.\n      2. Prior history of hypertensive crisis or hypertensive encephalopathy.\n      3. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to start of treatment.\n      4. History of hemoptysis (≥ one-half teaspoon of bright red blood per episode) within 1 month prior to start of treatment.\n      5. Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).\n      6. Current or recent (within 10 days of start of treatment) use of aspirin (\\> 325 mg\u002Fday) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol.\n      7. Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for \\> 2 weeks prior to start of treatment. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks prior to start of treatment.\n      8. Prophylactic anticoagulation for the patency of venous access devices is allowed, provided the activity of the agent results in an INR \\\u003C 1.5 × ULN and aPTT is within normal limits within 14 days prior to start of treatment.\n      9. Prophylactic use of low-molecular-weight heparin (i.e., enoxaparin 40 mg\u002Fday) is permitted.\n      10. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab.\n      11. History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to start of treatment.\n      12. Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.\n      13. Evidence of abdominal free air not explained by paracentesis or recent surgical procedure.\n      14. Serious, non-healing wound, active ulcer, or untreated bone fracture.\n      15. Proteinuria, as demonstrated by urine dipstick or \\> 1.0 g of protein in a 24-hour urine collection. All patients with ≥ 2+ protein on dipstick urinalysis at baseline must undergo a 24-hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours.\n      16. Clear tumour infiltration into the thoracic great vessels is seen on imaging.\n      17. Clear cavitation of pulmonary lesions is seen on imaging.",{"count":7,"type":21},[24],"This study will evaluate whether the combination of sacituzumab govitecan (SG) and bevacizumab will result in shrinkage of brain metastases from patients with non-squamous non-small cell lung cancer (NSCLC), with disease progression on chemotherapy and immunotherapy.",[608,28],"NSCLC Stage IV",[610,89,611,612],"non small cell lung cancer","bevacizumab","sacituzumab govitecan","2025-05-02",{"date":615,"type":33},"2025-05-06",{"date":617,"type":33},"2025-04-24",{"date":619,"type":21},"2027-04-01",{"name":230,"class":40},{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":548,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":634,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":478},"100443172","phase-2-rapid-simple-targeted-radiation-treatment-for-brain-metastases-100443172","NCT05050929","RAPid SimPLE Targeted Radiation Treatment for Brain Metastases","Randomized Phase II Non-Inferiority Study of 5-Day Versus 1-Day RAPid SimPLE (RAPPLE) Targeted Radiation Treatment for Brain Metastases","RAPPLE","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for participation in this study:\n\n* Age ≥ 18\n* Pathological diagnosis of a non-hematopoietic malignancy\n* Brain metastases of any size\n* Any number of untreated or progressing, previously treated brain metastases that can all be contoured and targeted\n* Presence of extracranial disease\n* Diagnosis-Specific Graded Prognostic Assessment ≤ 2.0. (https:\u002F\u002Fbrainmetgpa.com\u002F) or Graded Prognostic Assessment ≤ 2.0 (Appendix I)\n* Able to complete the EuroQOL (EQ-5D-5L) questionnaire\n* Willing and able to have regular imaging follow up\n* Feasible to start protocol treatment within 14 days of participant enrolment\n* Karnofsky Performance Score (KPS) ≥ 50\n\nExclusion Criteria:\n\nSubjects are excluded from the study if any of the following criteria apply:\n\n* Inability to have a brain MRI\n* WBRT less than 3 months prior to randomization\n* Disseminated leptomeningeal carcinomatosis (limited pachymeningeal disease is permitted)\n* Multiple sclerosis\n* Neurologically declining despite corticosteroids\n* Appropriate for surgery or stereotactic radiosurgery\n* Germ cell and primary brain tumours\n* Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission\n* Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the participant's safety, preclude safe administration of the planned protocol treatment, or prevent the participant from being managed according to the protocol guidelines\n* Pregnancy\n* Potentially fertile men or women of childbearing potential who are unwilling to employ highly effective contraception",{"count":630,"type":21},100,[24],"The aim of the study is to show that rapid, simple targeted radiotherapy to brain metastases with 8 Gy \u002F 1 is non-inferior to 20 Gy \u002F 5 in terms of overall survival for patients with poor prognosis.",[28],[635,636,637,638,639],"radiotherapy","randomized clinical trial","phase II","non-inferiority","overall survival","2025-04-15",{"date":642,"type":33},"2025-04-17",{"date":644,"type":33},"2022-07-01",{"date":646,"type":21},"2027-12-30",{"name":648,"class":40},"British Columbia Cancer Agency",{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":657,"maxAge":548,"enrollmentInfo":658,"targetDuration":4,"studyType":22,"phases":660,"briefSummary":661,"conditions":662,"keywords":663,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":673,"locationsCount":66},"100563064","beat-breast-trial-of-de-iptv-in-patients-with-primary-breast-cancer-with-brain-metastases-who-are-not-suitable-for-stereotactic-radiotherapy-100563064","NCT06611306","BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.","BEAT-Breast - Improving Outcomes for Breast Cancer Patients With Brain Metastases: a Pilot Nonrandomised Single Arm Phase 2 Clinical Trial in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy","BEAT-Breast","Inclusion Criteria\n\n1. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up\n2. Adult (aged 16+) patients, resident in the United Kingdom.\n3. Histologically confirmed primary breast cancer with brain metastases on MRI imaging\n4. The treating oncologist considers whole-brain radiotherapy to be the most suitable treatment outside of the trial.\n5. Eastern Cooperative Oncology Group Performance status 0, 1 or 2\n6. Able to respond to question about their quality of life, symptoms, and side effects remotely (via telephone assessments\n7. Life expectancy from extra-cranial disease \\>3 months\n\nExclusion Criteria\n\n1. Leptomeningeal disease\n2. \"Miliary\" pattern of metastases: patients with over 15 metastases are excluded (clinician-based assessment)\n3. Cystic metastases\n4. Previous whole or partial brain radiotherapy (previous surgery or SRS is acceptable)\n5. Plan for hippocampal-sparing whole brain radiotherapy.\n6. Unable to give informed consent.\n7. Prognosis less than 3 months\n8. Pregnant or nursing women\n9. Unable to complete a brain MRI and\u002For known allergy to gadolinium.","16 Years",{"count":659,"type":21},42,[53],"The aim of this study is to demonstrate if it is possible to delivering a novel and modern radiotherapy approach (Dose Escalated internal PTV (DE-iPTV)) and to collect health related quality of life in patients whose breast cancer has spread to the brain (brain metastases) at 8 weeks post enrolling into the study.\n\nThe main questions that have been set out to to answer are:\n\n* Is it possible to deliver the novel radiotherapy approach, DE-iPTV?\n* Is it possible to measure health -related quality of life?\n* What impact does the novel radiotherapy approach have on: patient's quality of life, control of the brain metastasis (control of the lesion) and steroid use?\n\nParticipants will:\n\n* Receive 5 doses of radiotherapy\n* Complete weekly quality of life (EQ-5D) assessments and medication (steroid) diaries (via telephone\u002F postal) until 12 weeks post enrolment\n* Be reviewed in clinic with up-to-date MRI scans at 8, 12 and 24 weeks post-enrolment\n* Complete a more detailed HRQoL panel of assessments will be assessed at baseline, 8 weeks, 12 weeks and 24 weeks post enrolment.",[28,512],[391,664,665],"Brain metastases","Metastatic Breast Cancer","2024-10-10",{"date":668,"type":33},"2024-10-15",{"date":670,"type":21},"2025-01-06",{"date":672,"type":21},"2026-12",{"name":674,"class":40},"Imperial College London",{"id":676,"slug":677,"hasResults":12,"nctId":678,"briefTitle":679,"officialTitle":679,"acronym":680,"eligibilityCriteria":681,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":682,"targetDuration":684,"studyType":356,"phases":4,"briefSummary":685,"conditions":686,"keywords":687,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":66},"100393050","local-ablative-therapy-for-patients-with-multiple-4-10-brain-metastases-100393050","NCT04397978","Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases","LAT-MUM","Inclusion Criteria:\n\n1. Male or female, ≥ 18 years of age\n2. Minimal 4 and up to a maximum of 10 synchronous BM diagnosed on a high resolution contrast-enhanced MRI scan (T1 gadolinium) not dated more than 4 weeks prior to inclusion.\n3. Maximal lesion diameter of single gross tumor volume (GTV) of 3 cm\n4. Maximal cumulative GTV (+CTV for cavity) of 30cm3\n5. Karnofsky performance status ≥ 70\n6. DS-GPA or expected overall survival (if no DS-GPA applicable) of ≥ 1.5 or \\>3 months respectively.\n7. Any solid primary tumour. Lymphoma, germ cell tumor, small cell lung carcinoma and multiple myeloma are excluded.\n8. Ability to provide written informed consent and to participate in the procedure of the questionnaires.\n\nExclusion Criteria:\n\n1. BM not amenable to SRT\n2. Previous SRT or surgery on the same lesion\n3. Co-morbidities considered clinically precluding the safe use of an MRI examination or SRT\n4. Any psychological, sociological or geographical issue potentially hampering compliance with the study\n5. Pregnancy\n6. Concurrent use of systemic therapy\n7. More than 10 BM on planning-MRI\n8. Maximum cumulative GTV (+CTV for cavity) of more than 30cm3 on planning-MRI\n9. A brainstem metastasis with a PTV of more than 20 cm3\n10. Leptomeningeal disease",{"count":683,"type":21},180,"3 Years","To observe the quality of life (QOL) and to report on toxicity and outcome parameters after the (repeated) use of local ablative therapy (LAT) i.e. stereotactic radiotherapy (SRT) for patients with multiple (4-10) brain metastases",[28],[688,664,689],"Stereotactic radiotherapy","Multiple (4-10)","2024-06-28",{"date":692,"type":33},"2024-07-01",{"date":694,"type":33},"2020-10-10",{"date":696,"type":21},"2025-06-01",{"name":698,"class":40},"Universitaire Ziekenhuizen KU Leuven",{"id":700,"slug":701,"hasResults":12,"nctId":702,"briefTitle":703,"officialTitle":704,"acronym":4,"eligibilityCriteria":705,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":706,"targetDuration":4,"studyType":22,"phases":707,"briefSummary":708,"conditions":709,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":711,"lastUpdatePostDateStruct":712,"startDateStruct":714,"completionDateStruct":716,"leadSponsor":717,"locationsCount":66},"100533850","a-feasibility-study-of-ihd-srt-for-bm-100533850","NCT06231186","a Feasibility Study of iHD-SRT for BM","Isotoxic High Dose (iHD) Fractionated Stereotactic Radiation Therapy (fSRT) for Intact Brain Metastases : a Feasibility Study","Inclusion Criteria:\n\n* Ability to understand and willingness to participate the research and sign the consent form\n* ECOG PS 0-2\n* The primary or metastatic lesion was confirmed by pathological histology as a malignant tumor\n* Head MRI diagnosis of brain metastasis with measurable lesions and technically feasible SRT (no more than 15 in number and 20cc in volume)\n* Estimated survival time ≥ 3 months\n\nExclusion Criteria:\n\n* Diffuse brain metastases, or combined with meningeal metastases, or technically difficult to perform SRT\n* With severe internal medicine complications or absolute contraindications for radiotherapy\n* other sufficient reasons to be unqualified, such as potential non-compliance with the clinical protocol, etc",{"count":217,"type":21},[53],"Brain metastasis is the most challenging disease in the field of tumor treatment, with a median overall survival of only 1-2 months for untreated patients. Stereotactic radiotherapy (SRT) has the advantages of precise positioning, relatively concentrated dosage, shorter course, and lower toxicity. Several studies could effectively protect cognitive function and achieve better tumor control rate. Currently, it has gradually replaced WBRT as standard local treatment choice for brain metastases. SRT includes Stereotactic Radiosurgery (SRS) and Fractional Stereotactic Radiotherapy (fSRT). With the continuous updating of domestic radiation therapy equipment, the use of high-resolution multi leaf gratings enables the accuracy of fSRT based on linear accelerators to reach 0.5mm or even lower levels, and has gradually become one of the main choices for local treatment of a limited number of patients with brain metastases.\n\nHowever, there is currently no prospective randomized controlled study data analyzing the clinical benefits of different segmentation and dosages of SRT. In retrospective data comparing different segmentation schemes, researchers found that higher BED was associated with better local control. However, the ASTRO guidelines recommend relatively conservative doses for SRT of brain metastases, especially as the lesion volume increases, and the recommended dose of BED10 for SRT was only 48 Gy (30 Gy\u002F5 Fx). This is based on the consideration that higher radiation exposure will bring a higher risk of radiation-induced brain necrosis. However, with the continuous updates of SRT treatment equipment and technology, existing technologies can achieve higher dose coverage for more brain metastases while meeting the normal tissue limit. Therefore, this study conducted a prospective intervention study to explore the feasibility and safety of optimizing SRT dosage based on normal tissue tolerance for the treatment of brain metastases, in order to further improve the therapeutic effect of intracranial lesions with brain metastases.\n\nThis study is designed as a single arm open prospective study, assuming that under this treatment regimen, the proportion of patients with lesion prescription dose BED10\\>50 Gy is 90%, and the incidence of radiation-induced brain necrosis within 1 year is 8.5%. The planned enrollment period is 2 years and follow-up period is 1 year. A total of 35 people need to be enrolled.",[28,710],"Stereotactic Radiotherapy","2024-04-08",{"date":713,"type":33},"2024-04-10",{"date":715,"type":33},"2024-03-15",{"date":672,"type":21},{"name":718,"class":40},"Ruijin Hospital"]