FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM
Boston Scientific Corporation
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.
Description
Glioblastoma (GBM) is a highly aggressive brain cancer with a grave prognosis, resulting in \<7% of patients surviving to five years post-diagnosis. External beam radiotherapy (EBRT) is currently a mainstay treatment for GBM; however, the dose delivered is limited by side effects. The targeted radiotherapy of the TheraSphere GBM Y-90 Glass Microsphere System (TheraSphere GBM) has promising potential to provide GBM patients with reduced side effects compared to external beam radiotherapy as well as a more effective treatment for this catastrophic disease. The TheraSphere GBM device utilized in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF) 2. Life expectancy ≥ 12 weeks 3. Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule 4. History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria 5. Have radiographic evidence of tumor progression/recurrence with measurable disease (≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according to RANO criteria 6. Prior surgery and treatment with combination of radiotherapy and chemothera…
Interventions
- DeviceTheraSphere GBM
Single treatment of TheraSphere GBM device
Locations (9)
- University of Alabama BirminghamBirmingham, Alabama
- University of California San DiegoSan Diego, California
- University of California San FranciscoSan Francisco, California
- Mayo JacksonvilleJacksonville, Florida
- Northwestern UniverityChicago, Illinois
- Johns Hopkins Interventional Radiology CenterBaltimore, Maryland