NCT06329570

Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: NaviFUS Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 minutes, patients will be administered microbubbles (MB) (Lumason®) at a dose of 0.1 mL/kg, along with optimal ultrasound exposure doses determined by the acoustic emission feedback FUS power control algorithm of the NaviFUS System. The treatment will be administered every 2 weeks up to 34 weeks or until evidence of progression disease (PD), intolerable toxicity precluding further treatment, non-compliance with study follow-up, or withdrawal of consent, whichever occurs first.

Conditions

• Glioblastoma Multiforme
• Glioblastoma
• Glioma
• Brain Tumor
• Neoplasms
• Neoplasms, Nerve Tissue

Interventions

Type	Name	Description
DEVICE	NaviFUS System	Open the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble
DRUG	Lumason	Open the BBB using focused ultrasound and microbubble
DRUG	Bevacizumab	An anti-angiogenic agent to block tumor growth

Timeline

• Start date: 2024-10-22
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2024-03-26
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study