Using brief electric fields during spine surgery to let CNS tumor markers into the blood
Official title: Liquid Biopsy Following Blood-Brain Barrier Disruption Using Barrier Disrupting Fields in Patients Undergoing Spine Surgery
Run by Sheba Medical Center · NCT07224451 · Data updated 2026-11-12
Try whether a short, targeted application of electric pulses during intradural spinal tumor surgery makes brain-derived proteins detectable in a blood sample for adults having this operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Ramat Gan) |
| Status | Recruiting |
| Started | October 16, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | November 4, 2025 |
| Trial ID | NCT07224451 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who can consent and are scheduled for intradural spinal tumor resection with intraoperative neuromonitoring at the study site are ideal candidates.
✕Probably not a fit
People not undergoing intradural spine surgery or those excluded by criteria (for example, implanted electrical devices, anticoagulation, pregnancy, seizures, or ongoing CSF leak) would not be eligible and are unlikely to benefit from this procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective feasibility study will apply barrier-disrupting fields (BDF)—short pulsed electric fields—during intradural spinal tumor resections to transiently open the blood-arachnoid barrier. Researchers will collect paired cerebrospinal fluid (CSF) and blood samples perioperatively and measure changes in CNS-derived biomarkers such as S100A, S100B and prostaglandin D2 isomerase. BDF treatment parameters are planned individually using finite-element simulations based on MRI to target desired electric fields on the arachnoid barrier. The primary efficacy endpoint is the rise in blood biomarker concentration after BDF compared with the subject's CSF levels, and safety will be tracked by recording procedure-related adverse events graded by CTCAE v5.0.
Why it matters
Potential benefit: If successful, this approach could allow less invasive blood-based detection of CNS tumor markers, reducing reliance on CSF sampling or invasive procedures.
How similar studies have gone: Preclinical rodent studies have shown BDF can enable CNS drug delivery and blood detection of brain proteins, but the clinical application for human blood-based CNS biomarker detection is novel and unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult subjects over the age of 18 * Able to sign informed consent * Candidates for intradural tumor resection spinal surgery with intraoperative neuromonitoring. Exclusion Criteria: * Pacemakers, or other implanted electric medical devices * Pregnant or lactating females * Major medical, neurologic or psychiatric condition who are judged as unable to fully comply with the study * History of skull fractures or previous brain surgery * American Society of Anesthesiologists grade \>2 * Anticoagulants treatment * Damage to the dura resulting in CSF leak * Patients with seizures/epilepsy
Where it's running
-
Sheba Medical Center
Ramat Gan, Israel Recruiting
Study contacts
- Principal investigator: Ran Harel, MD — Sheba Medical Center
- Study coordinator: Yael Mardor, PhD
- Email: yael.mardor@sheba.health.gov.il, yael.mardor@gmail.com
- Phone: +97235302993
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.