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

Sponsor
NaviFUS Corporation
Study ID
NCT06496971
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    An anti-angiogenic agent to block tumor growth
  • Microbubble — DRUG
    Open the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble
  • Low-Intensity Focused Ultrasound — DEVICE
    Open the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble

Study Details

This will be a prospective, randomized, standard of care (SoC) controlled, parallel, open-label, multicenter pivotal study to investigate the efficacy and safety of Bevacizumab (BEV) in combination with or without microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.

Key Dates

First listed
Jul 11, 2024
Start date
Nov 8, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of care (SoC) BEV alone
    SoC group will follow the standard operating procedures of BEV (10 mg/kg intravenous (IV) infusion over 30-90 minutes, following the instructions in the drug package insert).
  • Experimental: Microbubble-mediated FUS treatment with BEV (FUS-MB+BEV)
    FUS-MB+BEV group will follow the standard operating procedures of BEV (10 mg/kg intravenous (IV) infusion over 30-90 minutes, following the instructions in the drug package insert). After at least 30 minutes, patients will be administered microbubbles (MB) (SonoVue® ) 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.

Primary Outcome Measure

6-month progression-free survival (PFS-6) of Bevacizumab (BEV) with or without microbubble-mediated focused ultrasound (FUS-MB) using NaviFUS System [ Time Frame: Up to 6 months ]

Central Contacts

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