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

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 fracti

Trial Details

NCT ID
NCT07195591
Phase
PHASE3
Sponsor
GT Medical Technologies, Inc.
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • GammaTile®
  • External Beam Radiation Therapy
  • Temozolomide
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Neptune City, New Jersey, United States|40.20011,-74.02792
  • Valhalla, New York, United States|41.07482,-73.77513
  • Greenville, North Carolina, United States|35.61266,-77.36635

Key Eligibility 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 wi…
  • Are medically and surgically appropriate for resection.

For full eligibility, visit ClinicalTrials.gov.

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