Clinical trial · Interventional
Phase II Elderly/Frail 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)
NCT07821112CI-TRIAL-00126327ENDURANCEnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytic Tumor | CURATED_BROADER | 0.80 |
| Elderly GBM | — | UNRESOLVED | — |
| Elderly Glioblastoma | — | UNRESOLVED | — |
| GBM | Glioblastoma | ALIAS | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Glioma, Malignant | Malignant Glioma | ALIAS | 0.90 |
| Oligodendroglioma | Oligodendroglioma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GammaTile® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Newly Diagnosed Elderly or Frail Glioblastoma
- description
- GammaTile®
- interventionNames
- Device: GammaTile®
- type
- EXPERIMENTAL
- label
- Recurrent Elderly or Frail Glioblastoma
- description
- GammaTile®
- interventionNames
- Device: GammaTile®
- type
- EXPERIMENTAL
- label
- Newly Diagnosed Frail (Non-GBM) Malignant Glioma
- description
- GammaTile®
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Supratentorial * A bi-dimensionally measurable lesion of at least 10 mm, visible on two or more axial slices 5 mm apart. * The pre-operative tumor planned for resection is ≤ 7 cm in maximal dimension. * Tumor, which in the opinion of the enrolling neurosurgeon, is amenable to attempted gross total resection (GTR) or near total resection (NTR). * 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. * If multifocal, must be fully resectable in one operative bed. Surgical protocol will follow current institutional standards. * 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. * Karnofsky Performance Scale (KPS) 1. Elderly GBM: baseline KPS score of ≥ 60. 2. Frail GBM: baseline (pre-GBM diagnosis) is \<70 and surgical management is expected to improve KPS to ≥ 60. Exclusion Criteria: * Staged surgery planned (prior biopsy allowed). * Bilateral tumors, or multi-focal tumors that cannot be encompassed in one operative field. * Spinal tumors are excluded. * Enhancing extension into brainstem or thalamus, or significant invasion into the corpus callosum that would preclude a high likelihood of GTR or NTR. * Leptomeningeal disease not expected to be encompassed by the surgical resection. * Evidence of diffuse leptomeningeal disease that requires whole brain irradiation are excluded from this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.