Status:
RECRUITING
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Lead Sponsor:
GT Medical Technologies, Inc.
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
766 Patients enrolled
Trial Details
Trial ID
NCT07195591
Start Date
December 10 2025
End Date
December 1 2031
Last Update
December 17 2025
Active Locations (2)
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1
Westchester Medical Center
Valhalla, New York, United States, 10595
2
Brown University Health
Providence, Rhode Island, United States, 02903