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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
NaviFUS Corporation
Study ID
NCT06329570
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 22, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FUS-MB+BEV
    FUS treatment will be administered after BEV infusion to facilitate BBB opening.

Primary Outcome Measure

Adverse Events (AEs) [ Time Frame: up to 52 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Jason Sheehan, M.D., Ph.D.
[email protected]
Arthur Lung, Ph.D.
[email protected]
02-25860560

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By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Virginia· Charlottesville, VA

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