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GammaTile for Newly Diagnosed Glioblastoma

This study is looking at a new way to treat newly diagnosed glioblastoma (a type of brain cancer) using GammaTile®. GammaTile is a small device with radioactive seeds that is placed during surgery. The study compares this approach with the standard treatment, which includes external beam radiation therapy (EBRT) and the chemotherapy drug Temozolomide (TMZ). You might be able to join if you are 18 or older and have a suspected new diagnosis of glioblastoma. The main goal is to see if GammaTile improves how long people live after surgery. The current status of this study is unclear, and it plans to enroll 766 participants.

Study design
This is a Phase 3, open-label study where participants are randomly assigned to one of two treatment groups. It aims to compare the new treatment to the standard treatment.
What's involved
You would go through a screening period of up to 21 days, followed by surgery. Depending on your group, you would then receive radiation and chemotherapy for 4 or 6 weeks, starting about a month after surgery.
Compensation
Not stated in the trial record.
Follow-up
The study measures overall survival, which means tracking how long participants live from the time of surgery until death.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07195591

Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care

Recruiting
PHASE3Ages 18+InterventionalTreatment
GT Medical Technologies, Inc.
~766 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:GammaTile®External Beam Radiation TherapyTemozolomide

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over Days from surgery to death.

Conditions

Glioblastoma

Explore related trials

Glioblastoma

Where it's being run

7 sites across 7 states
Arizona1
Maryland1
New Jersey1
New York1
North Carolina1
Pennsylvania1
Rhode Island1

Who to contact

Kimberly Johnson
[email protected]
(833)662-0044
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must be ≥18 years of age.
Have radiographic suspicion of newly diagnosed glioblastoma (GBM).
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

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.

What this trial measures

  • Overall SurvivalDays from surgery to death.

    The primary endpoint of the study is OS, defined as the day from surgery to death. Patients who are still alive (or lost to follow-up) at the time of data analysis will be censored at the last time point they were known to be alive.