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An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM
Sponsor: Boston Scientific Corporation
Summary
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.
Official title: The ODYSSEY Study: An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-10-01
Completion Date
2029-09-30
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Device: TheraSphere GBM treatment of TheraSphere GBM device
All patients participating in the study will receive the same device. The study is evaluating the safety and efficacy of the device when it is used to deliver radiation to the area of the brain containing the tumor. The amount of radiation a patient receives depends on the dose group (cohort) to which they are assigned. Patients will be treated in groups of three at each dose level. If a dose level is considered safe, the next group of patients will receive a higher dose
Locations (5)
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, France
Hôpital de La Timone
Marseille, France
Universitätsklinikum Tübingen
Tübingen, Germany
University Medical Center Utrecht
Utrecht, Netherlands
Vall d'Hebron Institute of Oncology
Barcelona, Spain