TheraSphere for Recurrent Brain Cancer

(FRONTIER Trial)

Recruiting at 4 trial locations

Overseen By Franco Basarabescu

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Boston Scientific Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new radiation treatment using tiny radioactive beads for patients with aggressive brain cancer that has come back. The treatment aims to target the tumor more precisely and reduce side effects compared to standard treatments. GammaTile is a device that uses cesium-131 radiation-emitting seeds embedded in a collagen tile to provide targeted radiation therapy for brain tumors.

Eligibility Criteria

This trial is for adults over 18 with recurrent glioblastoma who've had prior treatment but not more than one round of radiotherapy or two surgeries. They must have adequate organ function, a life expectancy of at least 12 weeks, and be able to follow the trial procedures. Pregnant women can't participate, and those who can bear children must use birth control.

Inclusion Criteria

My organs and bone marrow are functioning well.

Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule

My scans show my tumor has grown and is 1 to 5 cm in size.

Exclusion Criteria

I have serious blood vessel issues that make certain medical procedures unsafe for me.

Subject has received any other investigational agents within 4 weeks of treatment, or is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team)

Known history of hypersensitivity reactions to iodinated and/or gadolinium-based contrast

Treatment Details

Interventions

• TheraSphere GBM (Brachytherapy)

Trial Overview The FRONTIER Study is testing TheraSphere GBM's safety and feasibility in patients with recurrent glioblastoma. It's an interventional study where participants receive this device to see if it's safe and technically possible to use as a treatment option.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology