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NCT07867886
NA

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

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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

Interventions

DEVICE

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