NCT07274787

Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma

An Open Label, Prospective, Pilot Study To Evaluate The Safety And Effectiveness Of The NaviFUS System In Conjunction With A Standard Treatment Regimen Of Bevacizumab (BEV) In Patients With Recurrent Glioblastoma

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary objective of this clinical investigation is to evaluate the safety of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM. Safety will be assessed using the following methods: Device-related Adverse Events (AEs) reported \[Time Frame: Through study completion, up to 24 weeks\]. To determine the incidence and severity of device-related AEs for bevacizumab plus NaviFUS System treatment in patients with recurrent glioblastoma multiforme (rGBM), the following safety parameters will be assessed: AEs, physical examination (PE), vital signs, neurological examination (NE), Karnofsky Performance Status (KPS), Mini-Mental State Examination (MMSE), clinical laboratory tests, proteinuria, and ECG.

Conditions

• GBM

Interventions

Type	Name	Description
DEVICE	NaviFUS System	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.
DRUG	Lumason	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.
DRUG	Bevacizumab	In this proposed clinical investigation, the NaviFUS System will be used in conjunction with BEV in recurrent GBM patients.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study