Recruiting

Phase 3

TMZ with GammaTileBeginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care

Sponsor:

GT Medical Technologies, Inc.

Code:

NCT07195591

Conditions

Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GammaTile®

External Beam Radiation Therapy

Temozolomide

Study Details

Brief 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.

Conditions

Glioblastoma

Study ID

NCT07195591

Start date

Dec 10, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

766 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Maximal safe resection followed by EBRT with concurrent TMZ followed by adjuvant TMZ (Arm A)

All patients will undergo tumor resection. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 30-fraction course of EBRT for 6 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles.

experimental: Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B)

All patients will undergo tumor resection + GammaTile implantation. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 20-fraction course of EBRT for 4 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles.

Interventions

GammaTile®

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

External 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

Temozolomide

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

Primary outcome measure

Overall Survival [ Time Frame: Days from surgery to death. ]

Central Contacts and Locations

Central contacts

Kimberly Johnson

(833)662-0044 kjohnson@gammatile.com

Locations

HonorHealth Scottsdale Osborn Medical Center

Recruiting

Scottsdale, Arizona, United States, 85251

Contacts

Maria Canchola, BSN, RN-BC

mcanchola@honorhealth.com

Principal Investigator:

John Wanebo, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jordina Rincon-Torroella, MD

410-955-1040 jrincon2@jhmi.edu

Principal Investigator:

Jordina Rincon-Torroella, MD

Jersey Shore University Medical Center | Hackensack

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Diane Doherty, MSN, RN-BC, OCN

diane.doherty@hmhn.org

Principal Investigator:

Nitesh Patel, MD

Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Contacts

Cristina Falo, PhD

Cristina.Falo@wmchealth.org

Principal Investigator:

Simon Hanft, MD

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Shayla Vickers, RN

Shayla.Vickers@ecuhealth.org

Principal Investigator:

K. Stuart Lee, MD

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Sarah Kimutis

724-228-1414 Sarah.Kimutis@ahn.org

Principal Investigator:

Matthew Shepard, MD

Brown University Health

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Maria Duffy

mduffy@brownhealth.org

Principal Investigator:

Clark Chen, MD, PhD

More Information

Sponsor

GT Medical Technologies, Inc.

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

Glioblastoma
Newly Diagnosed
GammaTile
External Beam Radiation Therapy
Temozolomide
Brain
Tumor
Brachytherapy
Radiation Therapy
Surgery
Resection
GBM
BRIDGES
EBRT
TMZ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GT Medical Technologies, Inc. on 2026-08-10.