Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
- Conditions
- Brain TumorBrain Tumor - MetastaticBrain Tumor, Adult MeningiomaBrain Tumor, PrimaryBrain Tumor, Adult: GlioblastomaBrain Tumor, Recurrent
- Interventions
- Device: GammaTile
- Registration Number
- NCT04427384
- Lead Sponsor
- GT Medical Technologies, Inc.
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
- Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description GammaTile GammaTile Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.
- Primary Outcome Measures
Name Time Method Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects 3 years No contrast enhancement in the area of the surgical bed
Overall Survival in High Grade Glioma Subjects 9 months Median duration of survival of subjects following surgical resection of tumor
Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects 12 months No contrast enhancement in the area of the surgical bed
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
HonorHeath Scottsdale Osborn Medical Center
🇺🇸Phoenix, Arizona, United States
University of Arkansas Medical Center
🇺🇸Little Rock, Arkansas, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
MemorialCare Health System
🇺🇸Laguna Hills, California, United States
Desert Regional Medical Center
🇺🇸Palm Springs, California, United States
California Pacific Medical Center, Sutter health
🇺🇸San Francisco, California, United States
Centura
🇺🇸Denver, Colorado, United States
Colorado Brain & Spine Institute: Swedish Campus
🇺🇸Englewood, Colorado, United States
BayCare Health
🇺🇸Clearwater, Florida, United States
Miami Cancer Institute, Baptist Health South Florida
🇺🇸Miami, Florida, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
🇺🇸Tampa, Florida, United States
Cleveland Clinic Florida- Weston
🇺🇸Weston, Florida, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
St. Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Indiana University, IU Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
KUMC Dept of Neurosurgery
🇺🇸Kansas City, Kansas, United States
Univeristy of Louisville Health
🇺🇸Louisville, Kentucky, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Willis-Knighton Medical Center
🇺🇸Shreveport, Louisiana, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Clinical Research dep. Davison Place. Englewood Health
🇺🇸Englewood, New Jersey, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
SUNY Upstate Medical Center
🇺🇸Syracuse, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
University of North Carolina Health
🇺🇸Chapel Hill, North Carolina, United States
Vidant Heath - ECU Medical Center
🇺🇸Greenville, North Carolina, United States
Atlantic Brain & Spine
🇺🇸Wilmington, North Carolina, United States
Mayfield Brain and Spine
🇺🇸Cincinnati, Ohio, United States
Kettering Health
🇺🇸Kettering, Ohio, United States
St Luke's University Health, Sacred Heart Campus
🇺🇸Allentown, Pennsylvania, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Brown University Health
🇺🇸Providence, Rhode Island, United States
CHI Memorial Hospital, CommonSpirit
🇺🇸Chattanooga, Tennessee, United States
UT Southwestern Simmons Cancer Center
🇺🇸Dallas, Texas, United States
Baylor St. Luke's Medical Center | Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Texas Health Science Center of San Antonio
🇺🇸San Antonio, Texas, United States
Texas Oncology-The Woodlands
🇺🇸The Woodlands, Texas, United States
INOVA Health
🇺🇸Fairfax, Virginia, United States
Virginia Mason
🇺🇸Seattle, Washington, United States