FRONTIER Phase 1 Study Evaluating Safety of TheraSphere GBM Device for Treating Recurrent Glioblastoma in Adults

What this Trial Is About

Glioblastoma GBM is a very aggressive brain cancer with a poor outlook, where less than 7% of patients live five years after diagnosis. Researchers are evaluating the safety and technical feasibility of the TheraSphere GBM Y-90 Glass Microsphere System, a targeted internal radiation therapy, in patients with recurrent GBM. This early feasibility study aims to explore whether this new treatment can deliver radiation more precisely to tumors and potentially reduce side effects compared to traditional external beam radiotherapy. The TheraSphere GBM device uses tiny glass microspheres containing yttrium-90, delivered through a catheter placed near the tumor via blood vessels. The treatment targets the tumor by taking advantage of blood flow, allowing a high dose of radiation to the tumor area. Participants are grouped based on the brain hemisphere and regions treated, receiving a projected radiation dose of 40 Gy 10%. The study involves angiographic evaluation to map blood vessels before treatment and confirms the treatment volume. Participants will be closely monitored through imaging tests like PET-CT and MRI to assess the delivery of radiation and tumor response. Researchers will track safety by recording various toxicities and side effects within 30 days after treatment, as well as longer-term outcomes such as neurological function, progression-free survival, and overall survival through six months post-treatment. The total study participation spans from enrollment through study completion with careful follow-up to evaluate treatment feasibility and patient safety.

A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM