[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-metastases-from-non-small-cell-lung-cancer-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-metastases-from-non-small-cell-lung-cancer-nsclc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,78,130,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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",false,"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\\-","ALL","18 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,28],"Brain Metastases, Adult","Brain Metastases From Non-small Cell Lung Cancer (NSCLC)",[30,31,32,33,34,35,36],"Brain Metastases","Radiation Therapy","NSCLC","Quality of Life","FACT-Br","NANO Scale","Pragmatic Trial","RECRUITING","2026-05-20",{"date":40,"type":41},"2026-05-26","ACTUAL",{"date":43,"type":41},"2025-06-05",{"date":45,"type":21},"2030-12",{"name":47,"class":48},"University of Vermont Medical Center","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":49},"100632303","novel-ga68-psma-petct-tracer-to-differentiate-between-radiation-necrosis-and-tumor-progression-in-brain-metastases-100632303","NCT07511933","Novel Ga68-PSMA PET\u002FCT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases","Novel Ga68-PSMA PET\u002FCT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Stereotactic Irradiated Brain Metastases. A Feasibility Study.","Inclusion Criteria:\n\nFor all groups:\n\n* Written informed consent\n* Age ≥ 18 years old\n* WHO PS 0-3\n* Measurable lesion ≥10mm according to RANO BM\n\nFor brain metastases groups:\n\n\\- newly diagnosed brain metastases from either NSCLC (group 1) or melanoma (group 2) or breast cancer (group 7).\n\nFor radiation necrosis groups:\n\n\\- Brain lesion at the location of a formerly brain metastases that has been treated with SRT (\\> 9 months ago), with the definite diagnosis of radiation necrosis at the location of formerly SRT-treated brain metastases of NSCLC (group 3), melanoma (group 4) and\u002F or breast cancer (group 8).\n\nFor diagnostic dilemma groups:\n\n\\- Brain lesion at the location of a formerly brain metastases with a diagnostic dilemma of radiation necrosis and recurrent brain metastases of NSCLC (group 5), melanoma (group 6) and\u002F or breast cancer (group 9).\n\nExclusion Criteria:\n\nFor all groups:\n\n* Known allergy to Ga68-PSMA\n* Epileptic seizure less than 7 days before Ga68-PSMA PET\u002FCT scan\n* Life expectancy less than 3 months\n* Patients with known prostate carcinoma\n* Pregnancy",{"count":58,"type":21},100,[60],"NA","This study aims to evaluate the diagnostic potential of 68-Gallium PSMA-PET\u002FCT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.",[28,63,64],"Brain Metastases From Melanoma","Brain Metastases From Breast Cancer",[30,66,67,68],"Radiation Necrosis","Diagnostic Imaging","Radiation-induced Toxicity","2026-03-30",{"date":71,"type":41},"2026-04-06",{"date":73,"type":41},"2019-12-24",{"date":75,"type":21},"2027-07-01",{"name":77,"class":48},"The Netherlands Cancer Institute",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":49},"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":86,"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.",[90,91,28,27,92],"Seizures","Primary Motor Cortex","Brain Metastases From Extra-cranial Solid Tumors",[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120],"brain metastases","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":123,"type":41},"2026-03-19",{"date":125,"type":41},"2025-12-23",{"date":127,"type":21},"2030-02",{"name":129,"class":48},"Ayal A. Aizer, MD",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":49},"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":138,"type":21},60,[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.",[27,142,28,92],"Brain Tumor - Metastatic",[144,30,145,146,147,148,105,106,149,150,151,152,66,153,154,155,156,157,158,159,160,161,109,162,163,164],"Brain Mets","Brain-directed stereotactic radiation","Brain radiation","Volatile Brain Metastases","Intracranial lesion","RANO","PTV","Planning Target Volume","Local Recurrence","Adaptive","VMAT","Volumetric Modulated Arc Therapy","Margin","Volatile","Rapid","Growth","Shift","neurocognitive","survival","same day","randomized",{"date":123,"type":41},{"date":167,"type":41},"2025-12-30",{"date":169,"type":21},"2029-09",{"name":129,"class":48},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100595585","risk-and-prognosis-of-brain-metastasis-in-non-small-cell-lung-cancer-100595585","NCT07034365","Risk and Prognosis of Brain Metastasis in Non-Small Cell Lung Cancer","Risk and Prognosis of Brain Metastasis in Non-Small Cell Lung Cancer: A Multicenter, Prospective, Observational Study","Inclusion Criteria:\n\n* Pathologically confirmed non-small cell lung cancer;\n* Age≥18 years old;\n* KPS score≥70;\n* Complete systemic imaging (including brain MRI) before treatment initiation, including contrast-enhanced MRI of the brain;\n* Receiving standard treatment;\n* Informed consent of the patient.\n\nExclusion Criteria:\n\n* Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);\n* Physical examination findings, clinical laboratory abnormalities, or other uncontrolled medical conditions identified by the investigator as potentially interfering with study results interpretation or increasing the patient's risk of - Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance;\n* Pregnant or lactating women.",{"count":179,"type":21},2000,"OBSERVATIONAL","This multi-center, prospective, observational study aim to construct a comprehensive model, integrating common clinical pathological parameters, radiographic features and multi-omics data, for assessing the risk and prognosis of brain metastasis in NSCLC. This model is intended to address the following clinical needs: (1) Identify patients at high risk of brain metastasis; (2) Optimize the combined strategies of local and systemic treatments; (3) Predict the survival outcomes of patients with brain metastases from NSCLC and provide evidence-based support for individualized treatment decisions.",[183,28],"NSCLC (Non-small Cell Lung Cancer)",[32,94,185],"prognosis","NOT_YET_RECRUITING","2025-06-25",{"date":189,"type":41},"2025-06-29",{"date":191,"type":21},"2025-08",{"date":193,"type":21},"2027-05",{"name":195,"class":48},"Fudan University"]