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ACTIVE NOT RECRUITING Phase 3

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

NCT04365374 · View on ClinicalTrials.gov ↗

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

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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GT Medical Technologies, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04365374 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Georgia, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04365374?

This trial is sponsored by GT Medical Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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