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 — DEVICEThe 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 — DRUGThe 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 — DRUGIn 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 + bevacizumabNaviFUS 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
- UCCC Clinical Trials Office513-584-7698
- Kyle Wang, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | - |
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