Trial Filter
BETAAn intelligent search tool for clinical trials
Official Title
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
Sponsor
GT Medical Technologies, Inc.
Enrollment
600
Timeline
Sep 2020 → Dec 2028
About This Study
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.
Eligibility Criteria
Inclusion Criteria
- 1Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
- 2Willing and able to provide informed consent and to participate in all evaluations.
Exclusion Criteria
- 1Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
- 2Major 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.
- 3Subjects 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.
Locations
53 sites participating in this study
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
Kimberly Bojanowski
HonorHeath Scottsdale Osborn Medical Center
Phoenix, Arizona 85027
John Wanebo, MD
University of Arkansas Medical Center
Little Rock, Arkansas 72205
Analiz Rodriguez, MD, PhD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →