RecruitingPhase 1NCT05303467

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

FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM


Sponsor

Boston Scientific Corporation

Enrollment

36 participants

Start Date

Jul 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a device called TheraSphere GBM, which delivers tiny radioactive beads directly into a recurrent glioblastoma (an aggressive brain tumor) to try to shrink or control it. It is a first-in-human safety study. **You may be eligible if...** - You are 18 or older with a confirmed glioblastoma diagnosis that has come back or continued to grow after standard treatment - Your tumor is measurable on MRI (between 1–5 cm) - You have already received surgery, combined radiation and chemotherapy (temozolomide) - You have a life expectancy of at least 12 weeks and reasonable health to undergo the procedure **You may NOT be eligible if...** - You have not had prior standard treatment for glioblastoma - Your tumor is too large or not measurable by MRI - You are not able to tolerate the procedure or follow-up requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETheraSphere GBM

Single treatment of TheraSphere GBM device


Locations(9)

University of Alabama Birmingham

Birmingham, Alabama, United States

University of California San Diego

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Mayo Jacksonville

Jacksonville, Florida, United States

Northwestern Univerity

Chicago, Illinois, United States

Johns Hopkins Interventional Radiology Center

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Lenox Hill Hospital

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05303467


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