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Brain cancer breakthrough? GammaTile trial aims to boost survival

NCT ID NCT07195591

Disease control Sponsor: GT Medical Technologies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This Phase 3 trial tests whether adding a special radiation tile (GammaTile) during brain surgery improves survival for people with newly diagnosed glioblastoma, a fast-growing brain cancer. About 766 participants will be randomly assigned to standard treatment (surgery, radiation, and chemo) or standard treatment plus GammaTile. The study is currently recruiting and will compare overall survival between the two groups.

What this could mean

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

Active substance
GammaTile (radiation-emitting tiles placed during surgery), external beam radiation, and temozolomide chemotherapy
What this could lead to
If successful, this could offer a more effective way to control glioblastoma by delivering radiation directly to the tumor site during surgery, potentially extending survival.
What could go wrong
This is an early-stage Phase 3 trial, and results may not confirm a benefit. Adding GammaTile could increase side effects like brain swelling or infection, and the treatment still requires ongoing chemotherapy.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 766 people

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

Started

Dec 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Major Criteria Includes the Following: Inclusion Criteria * Patients must be ≥18 years of age. * Have radiographic suspicion of newly diagnosed glioblastoma (GBM). o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and efficacy analyses. * Are medically and surgically appropriate for resection. * Have an estimated Karnofsky Performance Scale (KPS) score of ≥70. * Are able to receive standard of care treatment. Exclusion Criteria * A previous biopsy diagnosis other than IDH wild-type GBM. * Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography. * Have multi-focal enhancing tumors that cannot be encompassed in one operative field.

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Conditions

The condition(s) this trial relates to.

glioblastoma neoplasm

As listed by the trial registrant

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

Glioblastoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Allegheny Health Network

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Brown University Health

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Emory Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • HonorHealth Scottsdale Osborn Medical Center

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • Jersey Shore University Medical Center | Hackensack

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

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