NaviFUS + Bevacizumab for Glioblastoma

Overseen By UCCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for patients with recurrent glioblastoma, a type of brain cancer. Specific eligibility details are not provided, but typically participants must meet certain health standards and have no conditions that would interfere with the study.

Inclusion Criteria

I am 18 years old or older.

Must have measurable disease ≥ 10mm (according to RANO criteria).

I can care for myself but may need occasional help.

Exclusion Criteria

Pregnant or breast-feeding women.

Known sensitivity/allergy to MRI contrast agents, CT contrast agents, SonoVue® [Lumason®], bevacizumab, or any of their components.

Any other condition that, in the Investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.

What Are the Treatments Tested in This Trial?

Interventions

• Bevacizumab

Trial Overview The trial tests the NaviFUS system's safety and early effectiveness when used alongside Lumason microbubbles and Bevacizumab (BEV) in treating recurrent glioblastoma.

How Is the Trial Designed?

Group I: NaviFUS + bevacizumab Experimental Treatment 3 Interventions

NaviFUS system with concomitant microbubble administration in conjunction with bevacizumab (BEV)

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

NaviFUS Corporation

Industry Sponsor

Trials

10

Recruited

120+