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Radioactive tiles target brain tumors in frail patients

NCT ID NCT07821112

Disease control Sponsor: University of California, Irvine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether GammaTile, a collagen tile embedded with radioactive cesium-131 seeds, can be safely placed in the brain after surgery for malignant glioma. The trial enrolls elderly or frail patients with newly diagnosed or recurrent tumors. The main goals are to see how many participants can receive the implant and to track treatment-related side effects. The study also measures how long patients live without their cancer getting worse and their overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GammaTile, a bioabsorbable collagen tile embedded with radioactive cesium-131 seeds
What this could lead to
If it works, this could offer a treatment option for elderly or frail glioma patients who may not tolerate standard radiation therapy.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply broadly. The implant carries risks of bleeding, infection, and radiation side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

astrocytoma (excluding glioblastoma) glioblastoma glioma malignant glioma oligodendroglioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Astrocytoma Elderly GBM Elderly glioblastoma GBM Glioblastoma GLIOMA Glioma, malignant Oligodendroglioma

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

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