StudyFinder

A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

Recruiting

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.

I'm interested

All
Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
• Willing and able to provide informed consent and to participate in all evaluations.
Exclusion Criteria:

• Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
• 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.
• Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English).

Device: GammaTile

Brain Tumor, Recurrent, Brain Tumor, Brain Tumor, Primary, Brain Tumor - Metastatic, Brain Tumor, Adult: Glioblastoma, Brain Tumor, Adult Meningioma

Clark Chen - ccchen@umn.edu
Clark Chen
NA
STUDY00010689
NCT04427384
See this study on ClinicalTrials.gov

Back