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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 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.

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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.

Conditions Studied

Brain Metastases

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

FieldValue
Enrollment Target 230 participants
Start Date 2021-04-06
Est. Completion 2029-08-30
Phase Phase 3

Sponsor

GT Medical Technologies

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04365374

The ClinicalTrials.gov registry entry for NCT04365374 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 210-participant average among 67 other Brain Metastases trials with a reported enrollment target (10% higher). The listed sponsor is GT Medical Technologies, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.