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Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
NCT04427384 · GT Medical Technologies, Inc.
In plain English
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Official title
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
About this study
Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.
Eligibility 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.
Study design
Enrollment target: 600 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2020-09-11
Estimated completion: 2028-12-31
Last updated: 2026-02-13
Interventions
Device: GammaTile
Primary outcomes
- • Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects (12 months)
- • Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects (3 years)
- • Overall Survival in High Grade Glioma Subjects (9 months)
Sponsor
GT Medical Technologies, Inc. · industry
Contacts & investigators
ContactMichael A. Garcia, MD, MS · contact · mgarcia@gtmedtech.com · (833) 662-0044
ContactSita Patel, PhD, PharmD · contact · spatel@gtmedtech.com · (833)662-0044
InvestigatorMichael A. Garcia, MD, MS · study_director, GT Medical Technologies
All locations (54)
HonorHeath Scottsdale Osborn Medical CenterRecruiting
Phoenix, Arizona, United States
University of Arkansas Medical CenterRecruiting
Little Rock, Arkansas, United States
Eden Medical CenterRecruiting
Castro Valley, California, United States
UCSD Moores Cancer CenterRecruiting
La Jolla, California, United States
MemorialCare Health SystemRecruiting
Laguna Hills, California, United States
Desert Regional Medical CenterRecruiting
Palm Springs, California, United States
California Pacific Medical Center, Sutter healthRecruiting
San Francisco, California, United States
CenturaNot Yet Recruiting
Denver, Colorado, United States
Colorado Brain & Spine Institute: Swedish CampusRecruiting
Englewood, Colorado, United States
BayCare HealthRecruiting
Clearwater, Florida, United States
Ascension St. Vincent'sRecruiting
Jacksonville, Florida, United States
Miami Cancer Institute, Baptist Health South FloridaRecruiting
Miami, Florida, United States
Advent Health OrlandoRecruiting
Orlando, Florida, United States
Orlando HealthRecruiting
Orlando, Florida, United States
Florida Health Sciences Center, Inc. d/b/a Tampa General HospitalRecruiting
Tampa, Florida, United States
Cleveland Clinic Florida- WestonRecruiting
Weston, Florida, United States
Piedmont HealthcareRecruiting
Atlanta, Georgia, United States
Winship Cancer Institute of Emory UniversityRecruiting
Atlanta, Georgia, United States
St. Alphonsus Regional Medical CenterRecruiting
Boise, Idaho, United States
Goodman Campbell Brain and SpineRecruiting
Carmel, Indiana, United States
Indiana University, IU Health Methodist HospitalRecruiting
Indianapolis, Indiana, United States
KUMC Dept of NeurosurgeryRecruiting
Kansas City, Kansas, United States
Univeristy of Louisville HealthRecruiting
Louisville, Kentucky, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
Willis-Knighton Medical CenterWithdrawn
Shreveport, Louisiana, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Abbott Northwestern HospitalRecruiting
Minneapolis, Minnesota, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
University of NebraskaRecruiting
Omaha, Nebraska, United States
Clinical Research dep. Davison Place. Englewood HealthNot Yet Recruiting
Englewood, New Jersey, United States
Albany Medical CenterRecruiting
Albany, New York, United States
Mount Sinai HospitalActive Not Recruiting
New York, New York, United States
SUNY Upstate Medical CenterRecruiting
Syracuse, New York, United States
Montefiore EinsteinRecruiting
The Bronx, New York, United States
Westchester Medical CenterRecruiting
Valhalla, New York, United States
University of North Carolina HealthRecruiting
Chapel Hill, North Carolina, United States
Vidant Heath - ECU Medical CenterRecruiting
Greenville, North Carolina, United States
Atlantic Brain & SpineRecruiting
Wilmington, North Carolina, United States
Mayfield Brain and SpineRecruiting
Cincinnati, Ohio, United States
Kettering HealthRecruiting
Kettering, Ohio, United States
St Luke's University Health, Sacred Heart CampusRecruiting
Allentown, Pennsylvania, United States
Penn State HealthRecruiting
Hershey, Pennsylvania, United States
Allegheny Health NetworkRecruiting
Pittsburgh, Pennsylvania, United States
Brown University HealthRecruiting
Providence, Rhode Island, United States
CHI Memorial Hospital, CommonSpiritRecruiting
Chattanooga, Tennessee, United States
UT Southwestern Simmons Cancer CenterRecruiting
Dallas, Texas, United States
Baylor St. Luke's Medical Center | Baylor College of MedicineRecruiting
Houston, Texas, United States
Houston Methodist HospitalRecruiting
Houston, Texas, United States
University of Texas Health Science Center of San AntonioRecruiting
San Antonio, Texas, United States
Texas Oncology-The WoodlandsRecruiting
The Woodlands, Texas, United States
INOVA HealthRecruiting
Fairfax, Virginia, United States
Virginia MasonRecruiting
Seattle, Washington, United States