This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.
Male or female patients ≥ 18 years of age at the time of study enrollment.
Body mass index (BMI) ≥ 17 kg/m2.
Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (CE-MRI), following prior radiotherapy and temozolomide chemotherapy.
Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment.
Patients who have radiographic evidence of multifocal enhancing tumors.
Patients who have undergone previous treatment with anti-angiogenic therapy, including Bevacizumab, or other VEGF inhibitors or VEGF-receptor signaling inhibitors.
Patients who have previously received Carmustine wafers implantation during re-operation.
Patients who have previously received or are currently undergoing tumor treating fields (TTF) treatment.
Single group
NaviFUS System
DeviceOpen the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble
Lumason
DrugOpen the BBB using focused ultrasound and microbubble
Bevacizumab
DrugAn anti-angiogenic agent to block tumor growth
Adverse Events (AEs)
The incidence and severity of AEs associated with FUS-MB+BEV treatment in patients with rGBM
6-month Progression-Free Survival (PFS-6)
PFS-6 is the proportion of patients who remain progression-free at the 6-month time point, as determined by Response Assessment in Neuro-Oncology (RANO) Criteria, from the time of their first treatment.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of first treatment to the earliest date of the first objective documentation of radiographic progression disease based on RANO Criteria, death, or last known follow-up due to any cause whichever occurs first. PFS will be followed continuously till the End-of-Study.
One-year Survival Rate
One-year survival rate is the proportion of patients who remain alive at the one-year time point from the time of their first treatment.
Overall Survival (OS)
OS is defined as the time from the date of first treatment to the earliest date of death or last known follow-up due to any cause whichever occurs first. OS will be followed continuously while subjects are on study and via phone interviews every 3 months during the survival follow-up phase of the study.
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NaviFUS Corporation
Lead sponsor
NaviFUS US LLC
Collaborator
