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

Study acronym: BRIDGES
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 12 to 13
  2. Minor Trial sites expanded: 9 → 12 locations
  3. Minor Study sites: 7 to 9 Eligibility criteria expanded, about 8 words · Secondary endpoints: details revised at 1 of 5 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 5 entries
  4. Minor Study sites: 6 to 7v7
  5. Minor Study sites: 5 to 6v6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Study sites: 4 to 5v5
  2. Minor Study sites: 3 to 4v4
  3. Minor Study sites: 2 to 3v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2 · Start date changed from estimate of Nov 2025 to Dec 10, 2025v2 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Nov 2025 to Dec 10, 2025
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07195591
Lead Sponsor GT Medical Technologies, Inc.
Conditions Glioblastoma
Enrollment 766 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov