ClinicalTrials.gg
Not yet recruitingNCT07821112ENDURANCEUpdated Sep 23, 2026

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

A Phase 2 interventional study of GammaTile® in Glioma, Glioblastoma and GBM, sponsored by University of California, Irvine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by University of California, Irvine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 851 studies in Glioma with a site in United States — 143 open to participants now, 229 under way, 6 of them phase 3. Glioma · United States.

Planned enrollment
448th of 737
20 · median 30
Started
2026
with 37 others
Phase 2
227 of 851
21 open now
Primary completion
2027-10
later than 135 of 228 live
Registered
849th of 851
by date

Among the 851 studies in Glioma with a site in United States, this one is the 448th largest by planned enrollment of the 737 interventional ones, is one of 38 that started in 2026, is one of 227 in phase 2, reaches primary completion later than 135 of the 228 other live ones, and was the 849th registered.

By phase

851 studies; the count open now beside each. This study's row is marked.

Phase 1338 · 64 open
Phase 2this study227 · 21 open
Phase 1/292 · 16 open
No phase86 · 24 open
Observational77 · 13 open
Phase 320 · 3 open
Phase 46 · 2 open
Other kind4 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 1979; this study’s year is marked. 38 started in 2026.

Size and results

Median enrollment 30 across the 737 interventional studies, 69 across the 77 observational. Of the 564 that completed or were terminated, 203 (36%) have results posted.

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02

Study 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.

03

Conditions studied

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

Keywords

  • Glioma
  • Glioblastoma
  • GBM
  • Astrocytoma
  • Oligodendroglioma
  • GammaTile
  • GammaTile®
  • ENDURANCE
  • Elderly Glioblastoma
  • Elderly GBM
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Supratentorial
  • A bi-dimensionally 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.
  • 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

Exclusion Criteria:

  • Staged surgery planned (prior 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.
  • not expected to be encompassed by the surgical resection.
  • Evidence of diffuse leptomeningeal disease that requires whole brain irradiation are excluded from this trial.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Newly Diagnosed Elderly or Frail Glioblastoma

    GammaTile®

    Device: GammaTile®

  • Experimental
    Recurrent Elderly or Frail Glioblastoma

    GammaTile®

    Device: GammaTile®

  • Experimental
    Newly Diagnosed Frail (Non-GBM) Malignant Glioma

    GammaTile®

    Device: GammaTile®

  • Experimental
    Recurrent Frail (Non-GBM) Malignant Glioma

    GammaTile®

    Device: GammaTile®

Interventions

  • DeviceGammaTile®

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

    Also known as: GammaTile

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 28 days

  2. 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.

    Time frame: 24 months

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) as measured by Response Assessment in Neuro-Oncology (RANO) 2.0 on brain MRI with and without contrast.

    Time frame: 24 months

  2. Overall Survival (OS)

    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.

    Time frame: 24 months

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 108 non-industry phase 2 interventional studies under Glioma, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 89. This study's planned 12 months is below that.

Counting every sponsor, half of 131 studies reached it within 54 months; a quarter within 40 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2026
First posted
Sep 15, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2029
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07821112
Collaborators
GT Medical Technologies, Inc.
Responsible party
Carlen Yuen (Assistant Professor, University of California, Irvine) — Principal investigator
First posted
Sep 15, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2029 (estimated)
Last update
Sep 23, 2026

Study contacts

Chao Family Comprehensive Cancer Center University of California, Irvine
Contact
ucstudy@uci.edu
1-877-827-8839
University of California Irvine Medical
Contact
Carlen Yuen, MD
principal investigator · Chao Family Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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