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NCT04365374 · ClinicalTrials.gov registry record · Phase 3
Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)
A Phase 3 study of Brain Metastases, sponsored by GT Medical Technologies.
- Active
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT04365374: Active Phase 3 study of Brain Metastases, sponsored by GT Medical Technologies.
NCT04365374 is a Phase 3 study of Brain Metastases that is active but no longer recruiting, run by GT Medical Technologies. The registered enrollment target is 230 participants, above the 210-participant average among 67 other Brain Metastases trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04365374, a Phase 3 study of Brain Metastases, is active but no longer recruiting, sponsored by GT Medical Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Surgical bed control is defined as the absence of new nodular contrast enhancement in the index lesion surgical bed.
Conditions Studied
Interventions
- RADIATION Stereotactic Radiation Therapy
- DEVICE Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)
Study Locations (20)
Florida
- Ascension St. Vincent's- Riverside - Jacksonville
- Baptist MD Anderson Cancer Center- Jacksonville - Jacksonville
- HCA Florida First Coast Neurology- Orange Park - Orange Park
- Advent health Orlando - Orlando
- Orlando Health - Orlando
- Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital - Tampa
Georgia
- Piedmont Hospital - Atlanta
- Winship Cancer Institute of Emory University - Atlanta
Minnesota
- Abbott Northwestern Hospital - Minneapolis
- University Of Minnesota - Minneapolis
Missouri
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- SSM Health Saint Louis University Hospital - St Louis
Arizona
- HonorHeath Scottsdale Osborn Medical Center - Phoenix
Arkansas
- University of Arkansas Medical Center - Little Rock
Illinois
- RUSH University - Chicago
Indiana
- Indiana University, IU Health Methodist Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2021-04-06 |
| Est. Completion | 2029-08-30 |
| Phase | Phase 3 |
What the registry record for NCT04365374 still lists
NCT04365374 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 210-participant average among 67 other Brain Metastases trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Brain Metastases appearing as the primary indexed condition, and to 2 interventions - of which Stereotactic Radiation Therapy is the first listed.
NCT04365374 names 20 study sites across 12 states, led by Florida, Georgia, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04365374 about?
NCT04365374 is a clinical study titled "Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)". 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.
What is the current status of trial NCT04365374?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2021-04-06. Estimated completion is 2029-08-30.
What conditions does trial NCT04365374 study?
This clinical trial studies the following conditions: Brain Metastases.
What interventions are being tested in trial NCT04365374?
The interventions under investigation include: Stereotactic Radiation Therapy (RADIATION), Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) (DEVICE).
Who is sponsoring clinical trial NCT04365374?
This trial is sponsored by GT Medical Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04365374 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04365374's enrollment target sits among peer trials
230 4th of 67 higher than 64 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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