NCT04446416

Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients

An Open Label, Prospective, Pilot Study to Evaluate the Efficacy and Safety of Best Physician's Choice of Standard of Care Combined With NaviFUS System in Patients With Recurrent Glioblastoma Multiforme

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: NaviFUS Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, two stages, open-label, pilot study to investigate the efficacy and safety of FUS add-on bevacizumab (BEV) in rGBM patients. The BEV is the best physician's choice of standard of care for rGBM after prior radiotherapy and temozolomide chemotherapy in the LinKou Chang Gung Memorial Hospital. Eligible patients will be enrolled through the process of informed consent.

Detailed description

This trial will be divided into two stages. The study design and procedures will be as follows: Stage 1: Eligible patients will first be administered with BEV 10 mg/kg intravenous (IV) infusion. After 30-60 minutes, patients will receive microbubbles (MB) (SonoVue®) 0.1 mL/kg and optimal ultrasound exposure doses (based on the acoustic emission feedback FUS power control algorithm) generated from the NaviFUS System single exposure unit for up to two minutes every 2 weeks to transiently open the BBB. After 4 weeks of treatment with BEV and single unit FUS-MB treatment, if the patient experienced BBB opening using FUS treatment and BEV IV infusion without any serious adverse effects (such as brain significant bleeding), then the patient may proceed to stage 2. Stage 2: Patients who complete stage 1 will enter stage 2 to receive the BEV with MB-mediated multiple units of FUS treatment for up to five minutes (but the maximum exposure time per single unit is two minutes) every 2 weeks for up to 30 weeks or until evidence of progressive disease, unacceptable toxicity, non-compliance with study follow-up, or withdrawal of consent. After completion of study treatment, patients will be followed up for 28 days.

Conditions

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

Interventions

Type	Name	Description
DEVICE	NaviFUS System	Open the BBB using focused ultrasound and contrast agent SonoVue®
DRUG	Bevacizumab	An anti-angiogenic agent to block tumor growth

Timeline

• Start date: 2020-07-21
• Primary completion: 2022-09-30
• Completion: 2023-08-04
• First posted: 2020-06-24
• Last updated: 2026-04-09

Locations

1 site across 1 country: Taiwan