A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro (ONC)
Current Status: Open
Phase: IV
Principal Investigator: Aizenberg, Michele
Contact Information:
Jill Skorupa
jilskorupa@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04427384?term=NCT04427384&rank=1
Summary
This study is a multi-center, prospective, open-label, non-randomized, observational collection of clinical outcomes and patient reported outcomes. It is a Phase IV-Non-Interventional (NI)/Observational Trial of an FDA- Cleared Device. The primary objectives of this prospective non-interventional (NI) study are to evaluate real-world clinical outcomes and patient reported outcomes (PRO) that measure the effectiveness and safety of GammaTilesTM (GT). Data will be used to 1) benchmark clinical outcomes of GT therapy, 2) allow for comparisons of these outcomes to published clinical outcomes in the target population treated with standard of care (SOC) treatment(s), and (3) test for non-inferiority of surgical bed recurrence-free survival to current identified SOC for recurrent metastatic tumors and recurrent meningiomas as well as test for non-inferiority of mean overall survival for recurrent high grade gliomas.