Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT07274787
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • NaviFUS System — DEVICE
    The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB. The NaviFUS System is indicated for use to enhance the permeability of conventionally administered therapeutic agents into targeted brain tissue to enhance their therapeutic effects.
  • Lumason — DRUG
    The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB.
  • Bevacizumab — DRUG
    In this proposed clinical investigation, the NaviFUS System will be used in conjunction with BEV in recurrent GBM patients.

Study Details

This study will evaluate the safety and early effectiveness of the NaviFUS system with concomitant microbubble administration in conjunction with BEV in recurrent GBM patients.

Key Dates

Start date
Dec 1, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2029

Study Design

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

Arms

  • Experimental: NaviFUS + bevacizumab
    NaviFUS system with concomitant microbubble administration in conjunction with bevacizumab (BEV)

Primary Outcome Measure

Safety -assessed using -Device-related Adverse Events (AEs) reported [ Time Frame: Through study completion, up to 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati Medical CenterCincinnatiOhio45219-

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