Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
1 other identifier
observational
600
1 country
54
Brief Summary
The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
September 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 13, 2026
February 1, 2026
8.1 years
June 5, 2020
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects
No contrast enhancement in the area of the surgical bed
12 months
Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects
No contrast enhancement in the area of the surgical bed
3 years
Overall Survival in High Grade Glioma Subjects
Median duration of survival of subjects following surgical resection of tumor
9 months
Study Arms (1)
GammaTile
Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.
Interventions
Eligibility Criteria
Patients who received STaRT (GammaTile) intraoperatively.
You may qualify if:
- Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
- Willing and able to provide informed consent and to participate in all evaluations.
You may not qualify if:
- Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
HonorHeath Scottsdale Osborn Medical Center
Phoenix, Arizona, 85027, United States
University of Arkansas Medical Center
Little Rock, Arkansas, 72205, United States
Eden Medical Center
Castro Valley, California, 94546, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
MemorialCare Health System
Laguna Hills, California, 92653, United States
Desert Regional Medical Center
Palm Springs, California, 92262, United States
California Pacific Medical Center, Sutter health
San Francisco, California, 94109, United States
Centura
Denver, Colorado, 80201, United States
Colorado Brain & Spine Institute: Swedish Campus
Englewood, Colorado, 80113, United States
BayCare Health
Clearwater, Florida, 33756, United States
Ascension St. Vincent's
Jacksonville, Florida, 32204, United States
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida, 33176, United States
Advent Health Orlando
Orlando, Florida, 32803, United States
Orlando Health
Orlando, Florida, 32806, United States
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida, 33606, United States
Cleveland Clinic Florida- Weston
Weston, Florida, 33331, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
St. Alphonsus Regional Medical Center
Boise, Idaho, 83704, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, 46032, United States
Indiana University, IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
KUMC Dept of Neurosurgery
Kansas City, Kansas, 66160, United States
Univeristy of Louisville Health
Louisville, Kentucky, 40202, United States
Norton Cancer Institute
Louisville, Kentucky, 40241, United States
Willis-Knighton Medical Center
Shreveport, Louisiana, 71103, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
University of Minnesota
Minneapolis, Minnesota, 55414, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Clinical Research dep. Davison Place. Englewood Health
Englewood, New Jersey, 07631, United States
Albany Medical Center
Albany, New York, 12208, United States
Mount Sinai Hospital
New York, New York, 10029, United States
SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
Montefiore Einstein
The Bronx, New York, 10467, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina Health
Chapel Hill, North Carolina, 27599, United States
Vidant Heath - ECU Medical Center
Greenville, North Carolina, 27834, United States
Atlantic Brain & Spine
Wilmington, North Carolina, 28401, United States
Mayfield Brain and Spine
Cincinnati, Ohio, 45209, United States
Kettering Health
Kettering, Ohio, 45429, United States
St Luke's University Health, Sacred Heart Campus
Allentown, Pennsylvania, 18102, United States
Penn State Health
Hershey, Pennsylvania, 17033, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
Brown University Health
Providence, Rhode Island, 02906, United States
CHI Memorial Hospital, CommonSpirit
Chattanooga, Tennessee, 37404, United States
UT Southwestern Simmons Cancer Center
Dallas, Texas, 75235, United States
Baylor St. Luke's Medical Center | Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center of San Antonio
San Antonio, Texas, 78229, United States
Texas Oncology-The Woodlands
The Woodlands, Texas, 77380, United States
INOVA Health
Fairfax, Virginia, 22031, United States
Virginia Mason
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael A. Garcia, MD, MS
GT Medical Technologies
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
June 11, 2020
Study Start
September 11, 2020
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share