Intra-Arterial Bevacizumab as an Adjunct to Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorDheeraj Gandhi

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

18 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Dheeraj Gandhi

Lead sponsor

University of Maryland, Baltimore

Sponsor institution