Phase II Elderly/Frail Pts With Newly Diagnosed or Recurrent Malignant Glioma Treated With Cesium-131 GammaTile®

NCT07821112 | Not Yet Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: STUDY00001050UCI-25-151
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Glioma; Glioblastoma; GBM; Glioma, Malignant; Astrocytoma; Oligodendroglioma; Elderly GBM; Elderly Glioblastoma

Keywords

Glioma; Glioblastoma; GBM; Astrocytoma; Oligodendroglioma; GammaTile; GammaTile®; ENDURANCE; Elderly Glioblastoma; Elderly GBM

Outcome Measures

Primary Outcomes (2)

• 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

• 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. Adverse 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

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  24 months

• Overall Survival (OS)

  24 months

Study Arms (4)

Newly Diagnosed Elderly or Frail Glioblastoma

EXPERIMENTAL

GammaTile®

Device: GammaTile®

Recurrent Elderly or Frail Glioblastoma

EXPERIMENTAL

GammaTile®

Device: GammaTile®

Newly Diagnosed Frail (Non-GBM) Malignant Glioma

EXPERIMENTAL

GammaTile®

Device: GammaTile®

Recurrent Frail (Non-GBM) Malignant Glioma

EXPERIMENTAL

GammaTile®

Device: GammaTile®

Interventions

GammaTile® DEVICE

GammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.

Also known as: GammaTile

Newly Diagnosed Elderly or Frail Glioblastoma; Newly Diagnosed Frail (Non-GBM) Malignant Glioma; Recurrent Elderly or Frail Glioblastoma; Recurrent Frail (Non-GBM) Malignant Glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• GT Medical Technologies, Inc.: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Carlen Yuen, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

US (1)