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)
- Glioblastoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- GT Medical Technologies, Inc.
- Enrolment target
- 766
- Started
- 10 December 2025
- Main results due
- December 2031
- Study sites
- 12
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(12)
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States
Recruiting
Advent Health
Orlando, Florida, United States
Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
Johns Hopkins University
Baltimore, Maryland, United States
Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Recruiting
Jersey Shore University Medical Center | Hackensack
Neptune City, New Jersey, United States
Recruiting
Westchester Medical Center
Valhalla, New York, United States
Recruiting
East Carolina University
Greenville, North Carolina, United States
Recruiting
The Ohio State University
Columbus, Ohio, United States
Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Recruiting
Brown University Health
Providence, Rhode Island, United States
Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Recruiting
Showing 12 of 12 sites. 12 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07195591. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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