Clinical trial Recruiting at 49 sites Observational

Registry of patients with brain tumors treated with GammaTiles

Official title: A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

Run by GT Medical Technologies, Inc. · NCT04427384 · Data updated 2026-11-12

This study is testing how well GammaTiles treatment works for people with brain tumors after surgery, looking at their health and quality of life over five years.

More Brain Tumor trials

Quick facts

Study typeObservational
SexAll
Enrollment600 (estimated)
SponsorGT Medical Technologies, Inc.
Industry-sponsored
Drugs / interventionsradiation
Locations54 sites (Phoenix, Arizona and 53 other locations)
StatusRecruiting
StartedSeptember 11, 2020
Main results expectedOctober 31, 2028
Study endsDecember 31, 2028
Registry record updatedJuly 22, 2026
Trial IDNCT04427384 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients who have undergone maximum safe resection of their brain tumors and are willing to participate in follow-up evaluations.

Probably not a fit

Patients with major medical or psychiatric illnesses that could interfere with treatment completion or follow-up assessments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry study aims to evaluate the real-world clinical outcomes and patient-reported outcomes of patients with brain tumors who have undergone treatment with STaRT using GammaTiles. A total of 600 patients who have had maximum safe resection of their brain tumors will be enrolled, and data will be collected on various outcomes including local control, overall survival, quality of life, neurocognition, and adverse events over a period of five years. The study will benchmark the effectiveness and safety of this treatment approach against existing standard-of-care therapies.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of GammaTiles for treating brain tumors, potentially improving patient outcomes.

How similar studies have gone: This is the first observational registry study of R+STaRT using GammaTiles, making it a novel approach in this area.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
2. Willing and able to provide informed consent and to participate in all evaluations.

Exclusion Criteria:

1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
2. Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.
3. Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.

Where it's running

  • HonorHeath Scottsdale Osborn Medical Center
    Phoenix, Arizona, United States
    Recruiting
  • University of Arkansas Medical Center
    Little Rock, Arkansas, United States
    Recruiting
  • Eden Medical Center
    Castro Valley, California, United States
    Recruiting
  • UCSD Moores Cancer Center
    La Jolla, California, United States
    Recruiting
  • MemorialCare Health System
    Laguna Hills, California, United States
    Recruiting
  • Desert Regional Medical Center
    Palm Springs, California, United States
    Recruiting
Show 44 more locations
  • California Pacific Medical Center, Sutter health
    San Francisco, California, United States
    Recruiting
  • Colorado Brain & Spine Institute: Swedish Campus
    Englewood, Colorado, United States
    Recruiting
  • BayCare Health
    Clearwater, Florida, United States
    Recruiting
  • Ascension St. Vincent's
    Jacksonville, Florida, United States
    Recruiting
  • Miami Cancer Institute, Baptist Health South Florida
    Miami, Florida, United States
    Recruiting
  • Advent Health Orlando
    Orlando, Florida, United States
    Recruiting
  • Orlando Health
    Orlando, Florida, United States
    Recruiting
  • Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
    Tampa, Florida, United States
    Recruiting
  • Cleveland Clinic Florida- Weston
    Weston, Florida, United States
    Recruiting
  • Piedmont Healthcare
    Atlanta, Georgia, United States
    Recruiting
  • Winship Cancer Institute of Emory University
    Atlanta, Georgia, United States
    Recruiting
  • St. Alphonsus Regional Medical Center
    Boise, Idaho, United States
    Recruiting
  • Goodman Campbell Brain and Spine
    Carmel, Indiana, United States
    Recruiting
  • Indiana University, IU Health Methodist Hospital
    Indianapolis, Indiana, United States
    Recruiting
  • KUMC Dept of Neurosurgery
    Kansas City, Kansas, United States
    Recruiting
  • Univeristy of Louisville Health
    Louisville, Kentucky, United States
    Recruiting
  • Norton Cancer Institute
    Louisville, Kentucky, United States
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Henry Ford Health System
    Detroit, Michigan, United States
    Recruiting
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota, United States
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting
  • University of Nebraska
    Omaha, Nebraska, United States
    Recruiting
  • Albany Medical Center
    Albany, New York, United States
    Recruiting
  • SUNY Upstate Medical Center
    Syracuse, New York, United States
    Recruiting
  • Montefiore Einstein
    The Bronx, New York, United States
    Recruiting
  • Westchester Medical Center
    Valhalla, New York, United States
    Recruiting
  • Vidant Heath - ECU Medical Center
    Greenville, North Carolina, United States
    Recruiting
  • Atlantic Brain & Spine
    Wilmington, North Carolina, United States
    Recruiting
  • Mayfield Brain and Spine
    Cincinnati, Ohio, United States
    Recruiting
  • Kettering Health
    Kettering, Ohio, United States
    Recruiting
  • St Luke's University Health, Sacred Heart Campus
    Allentown, Pennsylvania, United States
    Recruiting
  • Penn State Health
    Hershey, Pennsylvania, United States
    Recruiting
  • Allegheny Health Network
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • Brown University Health
    Providence, Rhode Island, United States
    Recruiting
  • CHI Memorial Hospital, CommonSpirit
    Chattanooga, Tennessee, United States
    Recruiting
  • UT Southwestern Simmons Cancer Center
    Dallas, Texas, United States
    Recruiting
  • Baylor St. Luke's Medical Center | Baylor College of Medicine
    Houston, Texas, United States
    Recruiting
  • Houston Methodist Hospital
    Houston, Texas, United States
    Recruiting
  • University of Texas Health Science Center of San Antonio
    San Antonio, Texas, United States
    Recruiting
  • Texas Oncology-The Woodlands
    The Woodlands, Texas, United States
    Recruiting
  • INOVA Health
    Fairfax, Virginia, United States
    Recruiting
  • Virginia Mason
    Seattle, Washington, United States
    Recruiting
  • Centura
    Denver, Colorado, United States
    Not yet recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.