NCT07821112Not yet recruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 9 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- University of California, Irvine
- Diseases
- Glioblastoma
- NCT number
- NCT07821112
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From Oct 2026 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Staged surgery planned (prior biopsy allowed).
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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)
- Elderly GBM: baseline KPS score of ≥ 60.
- Frail GBM: baseline (pre-GBM diagnosis) is \<70 and surgical management is expected to improve KPS to ≥ 60.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California, Irvine Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.