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

Sponsor
NaviFUS Corporation
Study ID
NCT04446416
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jun 24, 2020
Start date
Jul 21, 2020
Status verified
Apr 2026
Primary completion
Sep 30, 2022
Completion
Aug 4, 2023

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab plus NaviFUS System
    Device: NaviFUS System BBB Disruption by FUS in recurrent GBM 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 every 2 weeks to transiently open the BBB. Drug: Bevacizumab 10 mg/kg every 2 weeks for up to 36 weeks or until evidence of progressive disease, unacceptable toxicity, non-compliance with study follow-up, or withdrawal of consent.

Primary Outcome Measure

Adverse Event [ Time Frame: 38 weeks ]

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