SURG-90. Rate of infection after craniotomy for brain tumor resection and permanent implantation of surgically targeted radiation therapy: initial report on the first 250 consecutive patients from a multi-institutional prospective study

INTRODUCTION Surgically targeted radiation therapy (STaRT) using Cesium-131 collagen tile brain brachytherapy (GammaTile®, GT Medical Technologies, Tempe, Arizona, USA) is FDA cleared for operable newly diagnosed intracranial malignant neoplasms and recurrent intracranial neoplasms. OBJECTIVE To assess the rate of infection after brain tumor resection (R) and permanent implantation of STaRT on a prospective, multi-institutional observational study. METHODS The prospective, observational registry (NCT04427384) evaluates clinical outcomes that measure the effectiveness and safety of R+STaRT. As a secondary endpoint of the registry, wound infections are pre-specified as an adverse event (AE) of particular focus and are tracked and attributed using Common Terminology for Adverse Events version 5. The first 250 consecutive patients undergoing R+STaRT from 30 centers were chosen for evaluation to help ensure adequate follow up, and these patients were treated with brain tumor resection and STaRT between 11/2020 and 10/2023. RESULTS 73.6% of cases were for recurrent tumors and 26.4% were for newly diagnosed tumors. 46.3% were glioblastomas, 34.3% were brain metastases, 12.4% were meningiomas, and 7.0% were “other.” Median follow-up was 11.9 months (range 0-36.3 months). There were surgical wound infections among 5 patients, four Grade 3 and one Grade 4. From the day of surgery, 4 infections were noted within the first 30 days, none occurred between 31-90 days, and 1 was noted 117 days after surgery. CONCLUSION This interim data analysis of the first 250 consecutive patients from 30 centers show an infection rate (Grade 3 or 4) of 2%, which is consistent with what would be expected with craniotomy without STaRT. This data supports the safety of STaRT in a wide variety of clinical scenarios.