A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
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.
Arms & interventions
- DeviceGammaTile
Surgically Targeted Radiation Therapy
Outcome measures
Primary
Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects
No contrast enhancement in the area of the surgical bed
Time frame: 12 months
Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects
No contrast enhancement in the area of the surgical bed
Time frame: 3 years
Overall Survival in High Grade Glioma Subjects
Median duration of survival of subjects following surgical resection of tumor
Time frame: 9 months
Eligibility criteria
Study locations (54)
HonorHeath Scottsdale Osborn Medical Center
Phoenix, Arizona, 85027
University of Arkansas Medical Center
Little Rock, Arkansas, 72205
Eden Medical Center
Castro Valley, California, 94546
UCSD Moores Cancer Center
La Jolla, California, 92093
MemorialCare Health System
Laguna Hills, California, 92653
Desert Regional Medical Center
Palm Springs, California, 92262
California Pacific Medical Center, Sutter health
San Francisco, California, 94109
Centura
Denver, Colorado, 80201
Colorado Brain & Spine Institute: Swedish Campus
Englewood, Colorado, 80113
BayCare Health
Clearwater, Florida, 33756
Ascension St. Vincent's
Jacksonville, Florida, 32204
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida, 33176
Advent Health Orlando
Orlando, Florida, 32803
Orlando Health
Orlando, Florida, 32806
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida, 33606
Cleveland Clinic Florida- Weston
Weston, Florida, 33331
Piedmont Healthcare
Atlanta, Georgia, 30309
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
St. Alphonsus Regional Medical Center
Boise, Idaho, 83704
Goodman Campbell Brain and Spine
Carmel, Indiana, 46032
Indiana University, IU Health Methodist Hospital
Indianapolis, Indiana, 46202
KUMC Dept of Neurosurgery
Kansas City, Kansas, 66160
Univeristy of Louisville Health
Louisville, Kentucky, 40202
Norton Cancer Institute
Louisville, Kentucky, 40241
Willis-Knighton Medical Center
Shreveport, Louisiana, 71103
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Henry Ford Health System
Detroit, Michigan, 48202
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
University of Minnesota
Minneapolis, Minnesota, 55414
University of Nebraska
Omaha, Nebraska, 68198
Clinical Research dep. Davison Place. Englewood Health
Englewood, New Jersey, 07631
Albany Medical Center
Albany, New York, 12208
Mount Sinai Hospital
New York, New York, 10029
SUNY Upstate Medical Center
Syracuse, New York, 13210
Montefiore Einstein
The Bronx, New York, 10467
Westchester Medical Center
Valhalla, New York, 10595
University of North Carolina Health
Chapel Hill, North Carolina, 27599
Vidant Heath - ECU Medical Center
Greenville, North Carolina, 27834
Atlantic Brain & Spine
Wilmington, North Carolina, 28401
Mayfield Brain and Spine
Cincinnati, Ohio, 45209
Kettering Health
Kettering, Ohio, 45429
St Luke's University Health, Sacred Heart Campus
Allentown, Pennsylvania, 18102
Penn State Health
Hershey, Pennsylvania, 17033
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Brown University Health
Providence, Rhode Island, 02906
CHI Memorial Hospital, CommonSpirit
Chattanooga, Tennessee, 37404
UT Southwestern Simmons Cancer Center
Dallas, Texas, 75235
Baylor St. Luke's Medical Center | Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
University of Texas Health Science Center of San Antonio
San Antonio, Texas, 78229
Texas Oncology-The Woodlands
The Woodlands, Texas, 77380
INOVA Health
Fairfax, Virginia, 22031
Virginia Mason
Seattle, Washington, 98101