[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656054":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":31,"interventions":47,"overallOfficials":54,"centralContacts":59,"locations":67,"responsibleParty":83,"collaborators":86,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":24,"enrollmentInfo":100,"targetDuration":24,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":116,"overallStatus":117,"whyStopped":24,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of California, Irvine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants who were able to receive the GammaTile Implant","Feasibility is defined by proportion of participants who were able to be treated with GammaTile","28 days",{"measure":14,"description":15,"timeFrame":16},"Number of Participants with Treatment-related Adverse Events","Safety and tolerability will be determined by the proportion, nature, and severity of treatment-related adverse events in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.\n\nAdverse events (AEs) are reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, magnetic resonance imaging, and any other medically indicated assessments.","24 months",[18,21],{"measure":19,"description":20,"timeFrame":16},"Progression-Free Survival (PFS)","Progression-Free Survival (PFS) as measured by Response Assessment in Neuro-Oncology (RANO) 2.0 on brain MRI with and without contrast.",{"measure":22,"description":23,"timeFrame":16},"Overall Survival (OS)","Overall Survival (OS) as measured by time from registration to death of any cause as documented dates of registration and death within the electronic medical system.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE",[32,38,41,44],{"label":33,"type":34,"description":35,"interventionNames":36},"Newly Diagnosed Elderly or Frail Glioblastoma","EXPERIMENTAL","GammaTile®",[37],"Device: GammaTile®",{"label":39,"type":34,"description":35,"interventionNames":40},"Recurrent Elderly or Frail Glioblastoma",[37],{"label":42,"type":34,"description":35,"interventionNames":43},"Newly Diagnosed Frail (Non-GBM) Malignant Glioma",[37],{"label":45,"type":34,"description":35,"interventionNames":46},"Recurrent Frail (Non-GBM) Malignant Glioma",[37],[48],{"type":49,"name":35,"description":50,"armGroupLabels":51,"otherNames":52},"DEVICE","GammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.",[33,42,39,45],[53],"GammaTile",[55],{"name":56,"affiliation":57,"role":58},"Carlen Yuen, MD","Chao Family Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":24,"email":64},"Chao Family Comprehensive Cancer Center University of California, Irvine","CONTACT","1-877-827-8839","ucstudy@uci.edu",{"name":66,"role":62,"phone":24,"phoneExt":24,"email":24},"University of California Irvine Medical",[68],{"facility":69,"status":24,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Chao Family Comprehensive Cancer Center, University of California, Irvine","Orange","California","92868","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-117.85311,33.78779,{"lat":79,"lon":78},[82],{"name":56,"role":62,"phone":63,"phoneExt":24,"email":64},{"type":58,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Carlen Yuen","Assistant Professor",[87],{"name":88,"class":89},"GT Medical Technologies, Inc.","INDUSTRY","100656054","phase-2-phase-ii-elderlyfrail-pts-with-newly-diagnosed-or-recurrent-malignant-glioma-tx-treated-with-cesium-131-gammatile-100656054",false,"NCT07821112","Phase II Elderly\u002FFrail Pts With Newly Diagnosed or Recurrent Malignant Glioma Treated With Cesium-131 GammaTile®","A Phase II Study of Elderly and Frail Patients With Newly Diagnosed or Recurrent Malignant Glioma Treated With Cesium-131 GammaTile® (ENDURANCE Trial)","ENDURANCE","Inclusion Criteria:\n\n* Supratentorial\n* A bi-dimensionally measurable lesion of at least 10 mm, visible on two or more axial slices 5 mm apart.\n* The pre-operative tumor planned for resection is ≤ 7 cm in maximal dimension.\n* Tumor, which in the opinion of the enrolling neurosurgeon, is amenable to attempted gross total resection (GTR) or near total resection (NTR).\n* Anticipated GT placement (i.e., closest aspect of post resection tumor bed anticipated to receive GT placement) that is \\> 15mm from the optic chiasm or brainstem.\n* If multifocal, must be fully resectable in one operative bed. Surgical protocol will follow current institutional standards.\n* Able to receive 5-aminolevulinic acid (5-ALA, Gleolan) or other institutionally standard immunofluorescent-guidance such as fluorescein, prior to surgery to optimize GTR or NTR of enhancing tumor.\n* Karnofsky Performance Scale (KPS)\n\n  1. Elderly GBM: baseline KPS score of ≥ 60.\n  2. Frail GBM: baseline (pre-GBM diagnosis) is \\\u003C70 and surgical management is expected to improve KPS to ≥ 60.\n\nExclusion Criteria:\n\n* Staged surgery planned (prior biopsy allowed).\n* Bilateral tumors, or multi-focal tumors that cannot be encompassed in one operative field.\n* Spinal tumors are excluded.\n* Enhancing extension into brainstem or thalamus, or significant invasion into the corpus callosum that would preclude a high likelihood of GTR or NTR.\n* Leptomeningeal disease not expected to be encompassed by the surgical resection.\n* Evidence of diffuse leptomeningeal disease that requires whole brain irradiation are excluded from this trial.","ALL","18 Years",{"count":101,"type":102},20,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","This is a phase 2, open-label clinical trial determining feasibility, safety, and tolerability of GammaTile® in elderly or frail subjects with newly diagnosed or recurrent malignant gliomas.",[108,109,110,111,112,113,114,115],"Glioma","Glioblastoma","GBM","Glioma, Malignant","Astrocytoma","Oligodendroglioma","Elderly Glioblastoma","Elderly GBM",[108,109,110,112,113,53,35,96,114,115],"NOT_YET_RECRUITING","2026-09-18",{"date":120,"type":121},"2026-09-23","ACTUAL",{"date":123,"type":102},"2026-10",{"date":125,"type":102},"2029-10",{"name":5,"class":6},1]