Sheba Medical Center has launched a groundbreaking clinical trial analyzing the potential of liquid biopsy following the disruption of the blood-brain barrier (BBB) using Barrier Disrupting Fields (BDF) in patients undergoing spine surgery. This innovative research centers on spinal tumor cases and holds promise for advancing diagnostic precision through non-invasive methods.
About the Study
Patients with spinal tumors are being recruited for this innovative study led by Sheba Medical Center to evaluate the use of liquid biopsy after BBB disruption during spine surgery, leveraging BDF technology. Liquid biopsy, renowned for its less invasive approach and analytical precision, may soon revolutionize how tumors are diagnosed and monitored.
Understanding Barrier Disrupting Fields and the Blood-Brain Barrier
What is the blood-brain barrier?
The blood-brain barrier is a selectively permeable membrane that helps protect the brain from harmful substances. However, for clinical procedures like tumor marker detection, temporarily disrupting this barrier opens opportunities for advanced diagnostics.
What are Barrier Disrupting Fields?
Barrier Disrupting Fields are specialized medical devices engineered to safely and precisely disrupt the BBB. Their application during spine surgery enhances access for sampling biomarkers from the cerebrospinal fluid and blood, facilitating accurate tumor analysis via liquid biopsy.
Clinical Significance of the Trial
This trial highlights the synergistic potential between BDF devices and liquid biopsy technologies. By enabling safe and controlled BBB disruption, BDF devices could make it feasible to extract molecular data essential for identifying tumor profiles and guiding targeted therapies.
Clinicians, regulatory professionals, and healthcare technologists should watch how these findings shape the use-case scenario for BDF’s clearance efficacy under Medical Device Regulations (MDR) criteria. Concurrently, outcomes could influence decisions on integrating BDF and liquid biopsy workflows in diagnostic infrastructure.
FAQ
-
What makes BDF-assisted BBB disruption safe?
The device employs controlled fields specifically designed not to harm brain tissue, meeting stringent standards for safety and performance.
-
How does this study differ from traditional biopsy approaches?
Traditional biopsy procedures are invasive, whereas liquid biopsy offers a non-invasive alternative, utilizing blood or cerebrospinal fluid markers for analysis.
-
Who can participate in the study?
Patients diagnosed with spinal tumors who meet study eligibility criteria are welcome to apply through Sheba Medical Center.
Conclusion
This clinical trial could pave the way for transformative developments in spinal tumor diagnostics, regulatory procedures, and liquid biopsy technologies. Professionals in clinical research, regulatory affairs, and diagnostics should stay attuned to the study’s findings.
Disclaimer
The information provided is intended for professionals and should not be considered legal advice. Readers are advised to consult applicable regulations and guidelines.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07224451?term=medical+device