GliomaPhase 2ENDURANCENCT07821112
Phase II Elderly/Frail Pts With Newly Diagnosed or Recurrent Malignant Glioma Treated With Cesium-131 GammaTile®
A Phase 2 study testing GammaTile® in people with Glioma and Glioblastoma, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma, GBM
- What is being tested?
- GammaTile®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Carlen Yuen, MD, 1-877-827-8839, ucstudy@uci.edu
About this study
Official title: 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.
- Conditions
- Glioma, Glioblastoma, GBM, Glioma, Malignant, Astrocytoma, Oligodendroglioma
- Being tested
- GammaTile®
- Keywords
- Glioma, Glioblastoma, GBM, Astrocytoma, Oligodendroglioma, GammaTile, GammaTile®, ENDURANCE, Elderly Glioblastoma, Elderly GBM
- Medical subject headings
- Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammaTile®Device
Also called GammaTile
GammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed Elderly or Frail Glioblastoma | Experimental | GammaTile® Receives: Device: GammaTile® |
| Recurrent Elderly or Frail Glioblastoma | Experimental | GammaTile® Receives: Device: GammaTile® |
| Newly Diagnosed Frail (Non-GBM) Malignant Glioma | Experimental | GammaTile® Receives: Device: GammaTile® |
| Recurrent Frail (Non-GBM) Malignant Glioma | Experimental | GammaTile® Receives: Device: GammaTile® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- GT Medical Technologies, Inc.
- Responsible party
- Principal investigator, Carlen Yuen, University of California, Irvine
- Investigators
- Carlen Yuen, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821112
- Sponsor's protocol ID
- STUDY00001050
- Other IDs
- UCI-25-151
- Acronym
- ENDURANCE
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Elderly and Frail Patients With Newly Diagnosed or Recurrent Malignant Glioma Treated With Cesium-131 GammaTile® (ENDURANCE Trial)
- ClinicalTrials.gov ID
- NCT07821112
- Acronym / sponsor ID
- ENDURANCE / STUDY00001050
- Conditions
- Glioma, Glioblastoma, GBM, Glioma, Malignant, Astrocytoma, Oligodendroglioma
- Keywords
- Glioma, Glioblastoma, GBM, Astrocytoma, Oligodendroglioma, GammaTile, GammaTile®, ENDURANCE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- GT Medical Technologies, Inc.
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed Elderly or Frail Glioblastoma | Experimental | Device: GammaTile®GammaTile® |
| Recurrent Elderly or Frail Glioblastoma | Experimental | Device: GammaTile®GammaTile® |
| Newly Diagnosed Frail (Non-GBM) Malignant Glioma | Experimental | Device: GammaTile®GammaTile® |
| Recurrent Frail (Non-GBM) Malignant Glioma | Experimental | Device: GammaTile®GammaTile® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GammaTile®Also: GammaTileGammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds. | Device | Newly Diagnosed Elderly or Frail Glioblastoma, Newly Diagnosed Frail (Non-GBM) Malignant Glioma, Recurrent Elderly or Frail Glioblastoma, Recurrent Frail (Non-GBM) Malignant Glioma |
Primary outcome
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
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.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Carlen Yuen, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GammaTile® in people with Glioma and Glioblastoma, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who were able to receive the GammaTile Implant (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.