illustration showing top view of brain through transparent skull with circle to indicate area of tumor.

TheraSphere™ GBM Y-90 Glass Microspheres

FRONTIER study

CAUTION: In the U.S. TheraSphere™ GBM is under an investigational device exemption for treatment of patients with recurrent glioblastoma and limited by Federal (or US) law to investigational use. The safety and effectiveness for this treatment has not been established.

FRONTIER study overview

The FRONTIER study is a first-in-human feasibility study assessing the use of TheraSphere™ GBM Y-90 Glass Microspheres in patients with recurrent glioblastoma (GBM). The purpose of the study is to evaluate the safety and feasibility of using this therapy in the brain to treat recurrent GBM.

Learn more about the FRONTIER study

Study design

Recurrent GBM

Up to 12 patients

Up to 5 sites

Summary

The FRONTIER study is a prospective, interventional, single-arm, multi-center study to assess the safety and technical feasibility of TheraSphere GBM Y-90 Glass Microspheres in patients with recurrent glioblastoma.

Patient criteria

Recurrent GBM patients
Treatment location in non-dominant hemisphere and non-eloquent regions
Accessible neurovascular anatomy allowing safe microcatheter placement (up to two locations)

Treatment

Single projected radiation absorbed dose to the treatment volume is 40 Gy ±10%

Primary outcome measures

Assessment of treatment-related limiting toxicities through 30 days post index procedure

Secondary outcome measures

Rate of any treatment-related adverse events and serious adverse events
Change in post-treatment neurological function
Technical success/feasibility of TheraSphere GBM Y-90
Objective Response Rate
Progression Free Survival
Overall Survival

Learn more about the full study design, patient criteria, and endpoints

Patient information

If you are a patient with recurrent GBM and looking for information about the FRONTIER study, you can review the patient brochure, watch a video explanation, and discuss with your doctor.

Filename: FRONTIER_Study_patient_brochure_PI-1474803-AA.pdf
Size: 1 MB
Format: application/pdf

Download a patient's guide to the FRONTIER study

Watch a video explaining the FRONTIER study

Referring physician information

If you have questions about the FRONTIER study and patient eligibility, please contact one of the principal investigators or site contacts below.

Northwestern University

City: Chicago, IL

Principal Investigator: Samdeep Mouli, MD 

Contact: Roger Stupp, MD

Contact: Samdeep Mouli, MD

Email:  
s-mouli@northwestern.edu

Lenox Hill Hospital

City: New York, NY

Principal Investigator: John Boockvar, MD  

Contact: Tamika Wong

Email:   twong4@northwell.edu   

Mayo Clinic Jacksonville

City: Jacksonville, FL

Principal Investigator: Alfredo Quinones-Hinojosa, MD

Contact: Aleeshba Basil

Email: Basil.aleeshba@mayo.edu

Johns Hopkins

City: Baltimore, MD

Principal Investigator: Clifford Weiss, MD  

Contact: Hannatu Bwayili

Email:   hbwayil1@jh.edu

University of California San Francisco

City: San Francisco, CA

Principal Investigator: Nicholas Butowski, MD

Contact: Stephanie Lewis

Email:  NeuroOncNewPatientCoord@ucsf.edu

Clinical trial managers

For more information about the FRONTIER study, please contact a clinical trial manager.

Franco Basarabescu at franco.basarabescu@bsci.com

Lilian Liu at lilian.liu@bsci.com

Sally Linda at sally.linda@bsci.com

CAUTION: In the U.S. TheraSphere™ GBM is under an investigational device exemption for treatment of patients with recurrent glioblastoma and limited by Federal (or US) law to investigational use. The safety and effectiveness for this treatment has not been established.

TheraSphere is a registered trademark of Theragenics Corporation used under license by Boston Scientific Medical Device Limited, a wholly owned indirect subsidiary of Boston Scientific Corporation.