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

September 9, 2026 updated by: Carlen Yuen, University of California, Irvine

A Phase II Study of Elderly and Frail Patients With Newly Diagnosed or Recurrent Malignant Glioma Treated With Cesium-131 GammaTile® (ENDURANCE Trial)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chao Family Comprehensive Cancer Center University of California, Irvine
  • Phone Number: 1-877-827-8839
  • Email: ucstudy@uci.edu

Study Contact Backup

  • Name: University of California Irvine Medical

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center, University of California, Irvine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Newly Diagnosed Elderly or Frail Glioblastoma
GammaTile®
Device: GammaTile®
GammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.
Other Names:
  • GammaTile
Experimental: Recurrent Elderly or Frail Glioblastoma
GammaTile®
Device: GammaTile®
GammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.
Other Names:
  • GammaTile
Experimental: Newly Diagnosed Frail (Non-GBM) Malignant Glioma
GammaTile®
Device: GammaTile®
GammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.
Other Names:
  • GammaTile
Experimental: Recurrent Frail (Non-GBM) Malignant Glioma
GammaTile®
Device: GammaTile®
GammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.
Other Names:
  • GammaTile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants who were able to receive the GammaTile Implant
Time Frame: 28 days
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
Time Frame: 24 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 24 months
Progression-Free Survival (PFS) as measured by Response Assessment in Neuro-Oncology (RANO) 2.0 on brain MRI with and without contrast.
24 months
Overall Survival (OS)
Time Frame: 24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

GT Medical Technologies, Inc.

Investigators

  • Principal Investigator: Carlen Yuen, MD, Chao Family Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001050
  • UCI-25-151 (Other Identifier: UCI CFCCC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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