The safety and effectiveness of the NaviFUS System are being rigorously evaluated for its investigational use in combination with Bevacizumab to address recurrent glioblastoma (GBM). The University of Cincinnati, in collaboration with NaviFUS Corporation, has announced this critical clinical trial, which is yet to begin recruitment as of December 12, 2025.
In this article
What are the objectives of the trial?
The study aims to explore the safety and potential clinical advantages of using the NaviFUS System alongside Bevacizumab, a widely used monoclonal antibody treatment for GBM. This combinatory approach targets enhancing drug delivery through focused-ultrasound technology. GBM represents one of the most challenging and aggressive forms of brain cancer, often showing resistance to standard treatments. By facilitating localized drug delivery, this approach could offer a new avenue in fighting recurrent GBM.
What interventions are being tested?
The interventions include:
- Device: The NaviFUS System, designed to enhance therapeutic delivery across the blood-brain barrier through focused ultrasound techniques.
- Drug: Lumason, a microbubble contrast agent, which works synergistically with the ultrasound to temporarily open the blood-brain barrier.
- Drug: Bevacizumab, an anti-vascular endothelial growth factor (VEGF) therapy, frequently administered in GBM treatments to inhibit tumor angiogenesis.
This combination represents a paradigm shift in creating targeted therapies for brain tumors. Moreover, the integration of innovative medical devices provides opportunities for improving drug efficacy and patient outcomes.
What is the current status of the study?
The trial is listed as “not yet recruiting” on ClinicalTrials.gov under the identifier NCT07274787. While the collaborators have outlined the study framework, recruitment of participants is awaited. Updates on enrollment timelines or location specifics will likely be detailed in subsequent announcements.
The University of Cincinnati and NaviFUS Corporation are spearheading this effort. Both entities bring significant expertise, with the former contributing research infrastructure and the latter its proprietary device technology.
Frequently Asked Questions
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Is the NaviFUS System approved for commercial use?
No. The system is currently under evaluation in clinical trials and is not yet approved for general use.
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Who can participate in the trial?
Eligibility requirements, including age, health conditions, and diagnostic criteria, will be available once recruitment commences.
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What is the purpose of using Lumason in the trial?
Lumason’s role is integral to temporarily opening the blood-brain barrier, enabling localized and enhanced delivery of Bevacizumab into the affected areas of the brain.
Conclusion
The forthcoming evaluation of the NaviFUS System in combination with Bevacizumab marks a significant step forward in addressing treatment-resistant recurrent glioblastoma. As this clinical trial gears up for recruitment, it holds promise for expanding therapeutic options for a devastating condition. Keep monitoring updates for enrollment opportunities and study outcomes.
Disclaimer
This article is for informational purposes only and does not constitute medical, legal, or regulatory advice. Please consult professional guidance for specific concerns.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07274787?term=medical+device