[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"elderly-gbm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:elderly-gbm":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"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":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33,34],"Glioma","Glioblastoma","GBM","Glioma, Malignant","Astrocytoma","Oligodendroglioma","Elderly Glioblastoma","Elderly GBM",[27,28,29,31,32,36,37,15,33,34],"GammaTile","GammaTile®","NOT_YET_RECRUITING","2026-09-18",{"date":41,"type":42},"2026-09-23","ACTUAL",{"date":44,"type":21},"2026-10",{"date":46,"type":21},"2029-10",{"name":48,"class":49},"University of California, Irvine","OTHER"]