Brain Tumor Clinical Trial
Official title:
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2028 |
Est. primary completion date | October 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English). |
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical Center | Albany | New York |
United States | St Luke's University Health, Sacred Heart Campus | Allentown | Pennsylvania |
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 | Eden Medical Center | Castro Valley | California |
United States | University of North Carolina Health | Chapel Hill | North Carolina |
United States | Mayfield Brain and Spine | Cincinnati | Ohio |
United States | BayCare Health | Clearwater | Florida |
United States | UT Southwestern Simmons Cancer Center | Dallas | Texas |
United States | Centura | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Clinical Research dep. Davison Place. Englewood Health | Englewood | New Jersey |
United States | Colorado Brain & Spine Institute: Swedish Campus | Englewood | Colorado |
United States | Vidant Heath - ECU Medical Center | Greenville | North Carolina |
United States | CHI Baylor St. Luke's Medical Center | Houston | Texas |
United States | Houston Methodist Hospital | Houston | Texas |
United States | Indiana University, IU Health Methodist Hospital | Indianapolis | Indiana |
United States | KUMC Dept of Neurosurgery | Kansas City | Kansas |
United States | Kettering Health | Kettering | Ohio |
United States | UCSD Moores Cancer Center | La Jolla | California |
United States | University of Arkansas Medical Center | Little Rock | Arkansas |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | Univeristy of Louisville Health | Louisville | Kentucky |
United States | Miami Cancer Institute, Baptist Health South Florida | Miami | Florida |
United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Mount Sinai Hospital | New York | New York |
United States | University of Nebraska | Omaha | Nebraska |
United States | Advent Health Orlando | Orlando | Florida |
United States | Orlando Health | Orlando | Florida |
United States | Desert Regional Medical Center | Palm Springs | California |
United States | HonorHeath Scottsdale Osborn Medical Center | Phoenix | Arizona |
United States | University of Texas Health Science Center of San Antonio | San Antonio | Texas |
United States | California Pacific Medical Center, Sutter health | San Francisco | California |
United States | Virginia Mason | Seattle | Washington |
United States | Willis-Knighton Medical Center | Shreveport | Louisiana |
United States | SUNY Upstate Medical Center | Syracuse | New York |
United States | Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital | Tampa | Florida |
United States | Texas Oncology-The Woodlands | The Woodlands | Texas |
United States | Westchester Medical Center | Valhalla | New York |
United States | Cleveland Clinic Florida- Weston | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
GT Medical Technologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects | No contrast enhancement in the area of the surgical bed | 12 months | |
Primary | Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects | No contrast enhancement in the area of the surgical bed | 3 years | |
Primary | Overall Survival in High Grade Glioma Subjects | Median duration of survival of subjects following surgical resection of tumor | 9 months |
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