Study Comparing Avastin Bevacizumab With or Without NaviFUS Ultrasound System in Adults With Recurrent Glioblastoma Multiforme

What this Trial Is About

Researchers are investigating the safety and effectiveness of Bevacizumab BEV with or without microbubble-mediated focused ultrasound FUS using the NaviFUS System in patients with recurrent glioblastoma multiforme rGBM. This pivotal, randomized, open-label study compares standard care BEV alone to BEV combined with FUS in patients who have previously undergone surgery, radiotherapy, and chemotherapy with temozolomide. BEV is considered the best current treatment choice for these patients after prior therapies. Participants will be randomly assigned to one of two groups. One group will receive BEV alone via intravenous infusion at a dose of 10 mgkg over 30-90 minutes every two weeks. The other group will receive the same BEV treatment followed by administration of microbubbles SonoVue at 0.1 mLkg and focused ultrasound exposure controlled by the NaviFUS System. Treatments will continue every two weeks for up to 34 weeks or until disease progression, intolerable side effects, non-compliance, or withdrawal. During the study, participants will be monitored through regular assessments including MRI scans, quality of life questionnaires, cognitive tests Mini-Mental State Examination, and evaluation of corticosteroid use and adverse events. The primary outcome is progression-free survival at six months. Secondary outcomes include survival rates up to two years, tumor response, local disease control, and performance status. The total study participation can last up to 36 months with ongoing safety and efficacy monitoring.

A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubble-mediated Focused Ultrasound (FUS-MB) Using NaviFUS System in Recurrent Glioblastoma Multiforme Patients