About this trial
This is a Phase 1, open-label, single-center, dose-escalation study evaluating the safety and tolerability of intra-arterial bevacizumab (IA-BEV) given as an adjunct to middle meningeal artery embolization (MMAE) in adults with non-surgical chronic subdural hematoma (cSDH). Up to 18 participants who are already scheduled to undergo MMAE as standard of care will receive a single dose of bevacizumab, delivered directly into the middle meningeal artery immediately before embolization, during the same procedure. Three dose levels (2.0, 3.5, and 5.0 mg/kg) will be tested using a standard 3+3 dose-escalation design to identify the maximum tolerated dose. The study will also collect imaging and blood biomarker data to help understand which patients may benefit most from this combined treatment approach.
Eligibility criteria
Qualifiers
Age 18-85 years
Scheduled to undergo MMAE as standard of care for cSDH, no concurrent surgical evacuation planned (prior surgery for the target cSDH allowed if ≥14 days elapsed)
Radiographically confirmed cSDH meeting specified unilateral/bilateral density criteria
cSDH volume 20-100 cc
Disqualifiers
Requires immediate/urgent surgical evacuation
Prior large craniotomy, membranectomy, or MMAE for the current target cSDH
Life expectancy <1 year
Uncontrolled bleeding disorder (INR >1.7, aPTT >35s, platelets <100,000/μL)
Trial design
Treatments tested in this trial
- Bevacizumab (intra-arterial)
Treatment groups
Locations
Sponsors and collaborators
Dheeraj Gandhi
Lead sponsor
University of Maryland, Baltimore
Sponsor institution