Spots Global Cancer Trial Database for Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
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Trial Identification
Brief Title: Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
Official Title: A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
Study ID: NCT04427384
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
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
UT Southwestern Simmons Cancer Center, Dallas, Texas, United States
CHI Baylor St. Luke's Medical Center, Houston, Texas, United States
Houston Methodist Hospital, 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
Virginia Mason, Seattle, Washington, United States
Contact Details
Name: Michael A. Garcia, MD, MS
Affiliation: GT Medical Technologies
Role: STUDY_DIRECTOR
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