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GammaTile® for Brain Tumors

(ENDURANCE Trial)

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Uo
Overseen ByUniversity of California Irvine Medical
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

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Carlen Yuen, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for elderly or frail adults who have just been diagnosed with, or have a recurrence of, malignant brain tumors like glioblastoma or astrocytoma. Participants must be considered too old or weak for standard treatments.

Inclusion Criteria

A bi-dimensionally measurable lesion of at least 10 mm, visible on two or more axial slices 5 mm apart
Anticipated GT placement > 15mm from the optic chiasm or brainstem
My tumor is located in the upper part of my brain.
See 5 more

Exclusion Criteria

My leptomeningeal disease cannot be fully removed by surgery.
My tumor has grown into areas of the brain that make full or near-full removal unlikely.
I do not have a tumor in my spine.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • GammaTile®

Trial Overview

The study is testing GammaTile®, a small implant that delivers radiation directly to the brain tumor site during surgery. The goal is to see if this treatment is safe and manageable in older or frail patients.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Recurrent Frail (Non-GBM) Malignant GliomaExperimental Treatment1 Intervention
Group II: Recurrent Elderly or Frail GlioblastomaExperimental Treatment1 Intervention
Group III: Newly Diagnosed Frail (Non-GBM) Malignant GliomaExperimental Treatment1 Intervention
Group IV: Newly Diagnosed Elderly or Frail GlioblastomaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

GT Medical Technologies, Inc.

Industry Sponsor

Trials
6
Recruited
1,700+

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