In Situ Injection of Anti-angiogenics in Patients With Brain Arteriovenous Malformations Not Elig… (NCT07075757) | Clinical Trial Compass
Not Yet RecruitingPhase 1
In Situ Injection of Anti-angiogenics in Patients With Brain Arteriovenous Malformations Not Eligible for Exclusion Treatment
France20 participantsStarted 2025-10-01
Plain-language summary
Brain arteriovenous malformations (bAVMs) are rare aggressive vascular malformations affecting mostly young and healthy adults. The most frequent revealing condition (in almost 50% of cases) is an intra-cerebral hemorrhage, which is a considerable source of disability and mortality. The only way to prevent a bleeding or a rebleeding is to perform an exclusion treatment (endovascular embolization, microsurgery, stereotactic radiosurgery, or a combination of these techniques). The major drawback of these treatments is the risk of severe complications, which can reach 20%, especially in patients presenting a bAVM with complex angio-architecture (i.e., grade IV to V in the Spetzler Martin grading scale). There is a growing evidence about the strong implication of angiogenesis (mainly mediated by the type A vascular endothelial growth factor \[VEGF-A\]) on the size and growth of the bAVM and even in the occurrence of bleeding events. Our hypothesis is that an in situ injection of bevacizumab, a monoclonal antibody inhibiting VEGF-A, in patients with bAVM deemed not suitable for exclusion treatment may be safe and help to reduce the nidus volume.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age ≥18 and \< 65 years at the time of inclusion
âś“. bAVM (i.e.: located in the brain, brain stem or cerebellum)
âś“. Spetzler-Martin grade IV - V on a brain MRI performed less than 2 months before inclusion
âś“. History of rupture and/or with intractable symptoms related to the bAVM (i.e.: intractable seizure, steal phenomenon, compressive symptoms)
Exclusion criteria
âś•. Adequate bone marrow function at inclusion :
âś•. Normal liver function (alanine transaminase \[ALT\] \< 56 UI/L and aspartate aminotransferase \[AST\] \< 40 UI/L) at inclusion
✕. Normal renal function (creatinine clearance ≥ 30 ml/min calculated with the Cockcroft-Gault formula) at inclusion
âś•. Complete COVID-19 vaccinal scheme, according to the French recommendations
âś•0. Affiliation to French Healthcare system (AME excluded)
What they're measuring
1
Dose limiting toxicity
Timeframe: Days 0 (day of the injection) to day 30