Clinical Trial

Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)

Active, Not Recruiting Phase 3
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Summary
This trial will be a randomized controlled study comparing the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following metastatic tumor resection which is the current standard of care.
Protocol Amendment History 44 amendments
This ClinicalTrials.gov record has been amended 44 times since 2020-04-24; most recent amendment 2025-10-06.
Status change: Recruiting → Active, Not Recruiting 2025-08-25
Status change: Not Yet Recruiting → Recruiting 2021-04-13
Trial Details
NCT Number NCT04365374
Lead Sponsor GT Medical Technologies, Inc.
Conditions Brain Metastases
Enrollment 230 participants
Start Date 2021-04-06
Primary Completion 2029-08-30 (estimated)
Study Completion 2029-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-07