A Prospective, Open-Label, Single-Arm Pilot Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)
NaviFUS Corporation
Summary
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.
Description
The study aims to demonstrate the high safety profile and effectiveness of BEV+FUS-MB targeted therapy for brain tumors. Any patient with a histological diagnosis of GBM who meets all of the specific eligibility criteria may participate in this study by signing informed consent in person or through their legal representative. Eligible patients will undergo a 2-week baseline observation screening period. Up to 10 eligible patients will be enrolled in this study. Eligible patients will follow the standard operating procedures of BEV (10 mg/kg intravenous (IV) infusion). After at least 30 minut…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients ≥ 18 years of age at the time of study enrollment. 2. Body mass index (BMI) ≥ 17 kg/m2. 3. 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. 4. Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment. 5. Patients must have radiographic evidence of either at least an 80% resection of e…
Interventions
- DeviceNaviFUS System
Open the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble
- DrugLumason
Open the BBB using focused ultrasound and microbubble
- DrugBevacizumab
An anti-angiogenic agent to block tumor growth
Location
- University of VirginiaCharlottesville, Virginia