An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM

概要

The purpose of this study is to test Y90 glass microspheres for people with recurrent brain cancer. Participation in this study will help researchers find the best dose for the treatment of the disease. The study will look at the safety of the Y90 glass microsphere device and if it works to help stop the growth of the tumor. In this study, the device is delivered directly to the tumor through the blood vessels/arteries using a catheter(s) (a specialized tubing). The device (very small glass beads) gives radiation directly to the tumor and nearby area. Although radiation is a standard treatment for most types of brain cancer, the delivery of radiation using the Y90 glass microsphere device differs and is an investigational procedure. To deliver the device a catheter(s) will be inserted through a blood vessel/artery in the forearm or groin, followed by an in-hospital stay after the treatment of up-to 36 hours. Participants will have regular follow-up visits with the study doctor to monitor their health and assess how the tumor responds to treatment. These visits will take place weekly during the first month, monthly for the next five months, and then approximately every two months until one year after treatment.