The overarching objective of this multicenter, prospective, observational registry study is to evaluate “real-world” clinical outcomes and patient-reported outcomes measuring safety and efficacy of a permanently implanted device with Cs-131 seeds embedded in a collagen carrier tile for intracranial neoplasms. 

Radiotherapy (RT) is the most effective adjuvant therapy for intracranial tumors. There is no current consensus as to the single best type of RT at diagnosis or recurrence. Intraoperative brachytherapy allows immediate initiation of RT when residual tumor burden is minimal. However, traditional methods have been limited by uneven dose distribution, complicated workflow, extended procedural times, equipment costs, frequent adverse events (AEs), and time-delays limiting adjunctive therapies. In response, a permanently implanted device with Cs-131 radiation seeds embedded in a bioresorbable collagen carrier tile (GammaTile, GT Medical Technologies, Tempe, AZ USA) was developed. Described as surgically targeted radiation therapy (STaRT) to distinguish it from external beam RT, it has demonstrated excellent safety and local control outcomes in early commercial use.

The registry is planned for 600 prospectively enrolled subjects at up to 50 sites. Adults undergoing intracranial tumor resection (R) with intra-operative STaRT placement are eligible. Information including demographics, pathology, survival, AEs, quality of life, serial MRIs, and surgical bed and/or distant recurrence will be collected through 5 years.

The first worldwide observational study of R+STaRT opened in 11/14/2020 and includes 41 subjects from 9 U.S. centers with new or recurrent gliomas, metastases, meningiomas, others. Available clinical and patient-reported outcomes will be reported. To-date, it appears feasible and with similar peri-op/post-op neurologic events, length-of-stay, as compared to historical controls.

This study will benchmark clinical outcomes of R+STaRT, allow for comparisons to existing treatments, and facilitate future clinical trials design. The device is FDA-cleared for use in newly diagnosed malignant and all recurrent intracranial neoplasms.