[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ayal A. Aizer, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100602997","phase-2-prophylactic-anti-seizure-medication-vs-no-anti-seizure-medication-for-patients-with-primary-motor-cortex-brain-metastases-100602997",false,"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","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30],"Seizures","Primary Motor Cortex","Brain Metastases From Non-small Cell Lung Cancer (NSCLC)","Brain Metastases, Adult","Brain Metastases From Extra-cranial Solid Tumors",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"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","RECRUITING","2026-03-17",{"date":62,"type":63},"2026-03-19","ACTUAL",{"date":65,"type":63},"2025-12-23",{"date":67,"type":20},"2030-02",{"name":69,"class":70},"Ayal A. Aizer, MD","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":71},"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":80,"type":20},60,[23],"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.",[29,84,28,30],"Brain Tumor - Metastatic",[86,87,88,89,90,91,43,44,92,93,94,95,96,97,98,99,100,101,102,103,104,105,47,106,107,108],"Brain Mets","Brain Metastases","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":62,"type":63},{"date":111,"type":63},"2025-12-30",{"date":113,"type":20},"2029-09",{"name":69,"class":70},""]