RecruitingPhase 3NCT07195591

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

Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM)


Sponsor

GT Medical Technologies, Inc.

Enrollment

766 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows: * A Screening/Baseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B. * A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B). * An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase. * An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg/m2/day orally for each Arm. * An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg/m2/day orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator. * An Early Discontinuation/Follow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days. For any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (BRIDGE) is testing whether placing radioactive tiles called GammaTile directly into the surgical cavity immediately after removing a newly diagnosed glioblastoma (an aggressive brain tumor) is safer or more effective than the current standard of care, which involves waiting for surgery to heal before starting radiation. **You may be eligible if...** - You are 18 years of age or older - Imaging suggests a newly diagnosed glioblastoma (brain cancer) - You are a suitable candidate for brain surgery and standard treatment - Your functional status (Karnofsky Performance Scale) is 70% or above — meaning you can care for yourself and carry out normal activity with minor effort **You may NOT be eligible if...** - You have a prior biopsy showing a different type of brain tumor (not IDH wild-type GBM) - You have contraindications to temozolomide chemotherapy, MRI, gadolinium contrast, or CT imaging - Your tumor involves multiple disconnected sites in the brain (multifocal enhancement) - Other medical or surgical factors make you ineligible at your doctor's discretion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGammaTile®

GammaTiles are a U.S. FDA-cleared, surgically targeted radiation therapy for patients with certain brain tumors. GammaTile consists of bioresorbable collagen tiles embedded with Cesium-131 (Cs-131) radioactive seeds

RADIATIONExternal Beam Radiation Therapy

External beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body

DRUGTemozolomide

TMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor


Locations(4)

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States

HMH Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Westchester Medical Center

Valhalla, New York, United States

Brown University Health

Providence, Rhode Island, United States

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NCT07195591


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