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Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma

NCT07274787 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • NaviFUS Corporation

    collaborator INDUSTRY

  • University of Cincinnati

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-06-01
Completion
2029-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07274787 on ClinicalTrials.gov