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.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | GT Medical Technologies, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 54 sites (Phoenix, Arizona and 53 other locations) |
| Status | Recruiting |
| Started | September 11, 2020 |
| Main results expected | October 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT04427384 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
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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
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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
- Study coordinator: Michael A. Garcia, MD, MS
- Email: mgarcia@gtmedtech.com
- Phone: (833) 662-0044
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.