Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma

NCT07274787 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: UCCC-BN-24-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

GBM

Outcome Measures

Primary Outcomes (1)

• Safety -assessed using -Device-related Adverse Events (AEs) reported

  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 \[Time Frame: Through study completion, up to 24 weeks\].

  Through study completion, up to 24 weeks

Secondary Outcomes (9)

• Progression-free survival at 6-months and 12-months as determined using the Radiologic Assessment in Neuro-Oncology (RANO) criteria.

  Pr6-months and 12-months

• Median PFS at 6-months and 12-months as determined using the RANO criteria

  6-months and 12-months

• Objective response rate (ORR) as determined using the RANO criteria at Week 8, 16, and 24.

  Week 8, 16, and 24.

• Overall survival (OS) at 6 & 12 months.

  6 & 12 months

• Median OS at 18 months.

  18 months.

Study Arms (1)

NaviFUS + bevacizumab

EXPERIMENTAL

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

Device: NaviFUS System; Drug: Lumason; Drug: Bevacizumab

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.

NaviFUS + bevacizumab

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.

NaviFUS + bevacizumab

Bevacizumab DRUG

In this proposed clinical investigation, the NaviFUS System will be used in conjunction with BEV in recurrent GBM patients.

NaviFUS + bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male/female patients ≥ 18 years of age.
• Histologically confirmed glioblastoma at original diagnosis, recurrent after prior radiotherapy and temozolomide chemotherapy.
• Must have measurable disease ≥ 10mm (according to RANO criteria) .
• Interval since completion of radiation treatment (including radiation at original diagnosis and/or radiation for recurrent disease) ≥ 12 weeks.
• If on steroids, must be on a stable dose for ≥ 7 days prior to study treatment.
• Body mass index (BMI) ≥17 kg / m2.
• Minimum interval since last drug therapy:
• week for non-cytotoxic agents (e.g., interferon, tamoxifen), daily chemotherapy (e.g., metronomic temozolomide, cytoxan) or targeted therapies administered daily (e.g., gleevec, tarceva).
• weeks since last cytotoxic therapy.
• weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., carmustine).
• Life expectancy ≥ 12 weeks.
• KPS Score \> 60.
• Adequate hepatic, renal, coagulation, and hematopoietic function:
• Hemoglobin ≥ 8 g/dL.
• Platelets ≥ 100,000/mm3.

You may not qualify if:

• \) Previous treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR), including bevacizumab.
• \) New York Heart Association (NYHA) Grade II or greater congestive heart failure requiring hospitalization within 12 months prior to screening.
• \) Hypertension (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg).
• \) Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, severe cerebral or myocardial infarction, cardiac shunt, heart attack within the previous 12 months, stroke (except for transient ischemic attack; TIA) within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
• \) Unstable Pulmonary Disease or Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening.
• \) Implanted pacemaker, defibrillator or deep brain stimulator, or other implanted electronic devices in the brain or documented clinically significant arrhythmias.
• \) Major surgery such as intra-thoracic, intra-abdominal or intra-pelvic (with the exception of craniotomy), open biopsy or significant traumatic injury ≤ 4 weeks prior to screening, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to screening, or who have not recovered from side effects of such procedure or injury.
• \) Known human immunodeficiency virus (HIV) positivity.
• \) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of screening.
• \) Pregnant or breast-feeding women.
• \) Known sensitivity/allergy to MRI contrast agents, CT contrast agents, SonoVue® \[Lumason®\], bevacizumab, or any of their components.
• \) Abnormal baseline findings considered by the Investigator to indicate conditions that might affect study endpoints.
• \) Hemorrhage or cyst within the ROI.
• \) ROI in the deep center brain with crucial brain functions, such as in the region of the brain stem.
• \) The receipt of an investigational drug within a period of 4 weeks prior to the first FUS exposure.

Sponsors & Collaborators

• University of Cincinnati: lead
• NaviFUS Corporation: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

UCCC Clinical Trials Office

CONTACT

513-584-7698; cancer@uchealth.com

Kyle Wang, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open Label

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 10, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

US (1)