A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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 criteria
Qualifiers
Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
Life expectancy ≥ 12 weeks
Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule
History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria
Disqualifiers
Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa, tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain, brainstem, corticospinal tract, internal capsule, cerebral peduncle), tumor approximating or invading the brainstem and/or optic chiasma, leptomeningeal disease, or extracranial metastatic disease
Have received more than 1 course of prior cranial radiotherapy (EBRT)
Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy
Have received more than 2 systemic treatment protocols (lines of treatment), not including maintenance temozolomide
Trial design
Treatments tested in this trial
- TheraSphere GBM
Treatment groups
36 Participants
are divided into 4 treatment groupsLocations
9Alabama
University of Alabama Birmingham35294, Birmingham United States
California
University of California San Diego92103, San Diego United States
University of California San Francisco94143, San Francisco United States
Florida
Mayo Jacksonville32224, Jacksonville United States
Sponsors and collaborators
Boston Scientific Corporation
Lead sponsor
Source ClinicalTrials.gov