Actively Recruiting
Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)
Led by NaviFUS Corporation · Updated on 2026-04-09
10
Participants Needed
1
Research Sites
179 weeks
Total Duration
On this page
Sponsors
N
NaviFUS Corporation
Lead Sponsor
N
NaviFUS US LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.
CONDITIONS
Official Title
Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older at enrollment
- Body mass index (BMI) of 17 kg/m2 or higher
- Histological diagnosis of glioblastoma with clear evidence of recurrence confirmed by contrast-enhanced MRI after prior radiotherapy and temozolomide chemotherapy
- Completed any surgery for recurrence and have recovered from surgery effects
- Radiographic evidence of at least 80% tumor resection after recurrence or residual tumor volume less than or equal to 20 cm3
- Stable or decreasing corticosteroid dose for at least 1 week before first treatment if corticosteroids are used
- At least 4 weeks since major invasive procedures and recovered from surgery effects
- At least 1 week since minor surgical procedures or core biopsies
- Recovered from prior therapy toxic effects: 4 weeks since investigational drug or device, 4 weeks since chemotherapy, 6 weeks since nitrosourea chemotherapy, and 12 weeks since radiotherapy completion
- Life expectancy of 12 weeks or more
- Karnofsky Performance Status (KPS) of 70 or higher
- Adequate blood counts and organ function within 2 weeks before treatment
- Targeted FUS exposure area located close to cortex and at least 30 mm beneath skull bone
- Negative pregnancy test within 2 weeks before treatment for females of childbearing potential
- Agree to use effective contraception from before first treatment until 6 months after last treatment if applicable
- Able and willing to have an intravenous line for Bevacizumab and have hair shaved where FUS membrane contacts
- Able to provide informed consent and comply with study procedures
You will not qualify if you...
- Presence of multifocal enhancing tumors on imaging
- Previous treatment with anti-angiogenic therapy including Bevacizumab or other VEGF inhibitors
- Prior implantation of Carmustine wafers during re-operation
- Current or prior tumor treating fields (TTF) therapy
- Significant cardiovascular disease including NYHA Grade II or higher heart failure within past 12 months, unstable angina, recent myocardial infarction within 6 months, or cardiac shunt
- Stroke (except transient ischemic attack) within past 6 months
- Implanted electronic devices such as pacemakers, defibrillators, neurostimulators, or cochlear implants
- Uncontrolled hypertension with systolic >150 mmHg or diastolic >100 mmHg despite medication within 2 weeks before treatment
- History or evidence of bleeding disorders, pulmonary hemorrhage grade 2 or higher within 1 month, or arterial/venous thrombosis within 6 months
- Unstable pulmonary disease or COPD exacerbation requiring hospitalization
- Psychiatric or social conditions limiting compliance
- Known HIV positive status
- Active bacterial or fungal infection requiring intravenous antibiotics
- Active gastroduodenal ulcer, gastrointestinal perforations, fistula, or intra-abdominal abscess within 6 months
- Use of anticoagulant or antiplatelet therapy within 1 week before treatment
- Known allergies to MRI or CT contrast agents, Lumason®, Avastin®, or components
- Pregnant or breastfeeding women
- Use of recreational drugs or history of addiction
- Other severe uncontrolled medical conditions that increase risk or affect compliance
- Any condition that may increase patient risk or affect study evaluation at investigator's discretion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
S
Sheang-Tze Fung, Ph.D.
CONTACT
A
Arthur Lung, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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