The natural history of radiographically defined vertebrobasilar nonsaccular intracranial aneurysms.
Kelly D Flemming, David O Wiebers, Robert D Brown...
https://pubmed.ncbi.nlm.nih.gov/16123548Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID02638701
Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms
Led by University of California, San Francisco · Updated on 2025-07-08
8
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dolichoectatic vertebrobasilar (DVB) aneurysms are rare brain aneurysms often large and fusiform, making traditional surgical treatments risky or ineffective. These aneurysms carry a high risk of serious complications such as subarachnoid hemorrhage, ischemic stroke, and brainstem compression, with significant neurological deficits and mortality rates noted over time. Researchers are evaluating infliximab, a tumor necrosis factor-alpha (TNFα) inhibitor, for its potential to reduce aneurysm growth and complications since this therapy has shown benefits in other vascular inflammatory conditions but has not yet been studied for brain aneurysms. Participants will receive infliximab intravenously at a dose of 3 mg/kg at weeks 0, 3, and 7, followed by doses every 8 weeks for a total treatment duration of 12 months. Magnetic resonance imaging (MRI) will be performed at the start, 12 months, and 24 months to monitor changes in aneurysm size and blood flow characteristics. The study is sponsored by the University of California, San Francisco, and includes phase 1 and 2 evaluations. During the trial, participants will undergo regular assessments including MRI scans to measure aneurysm volume and computational fluid dynamics parameters such as flow velocity, shear stress, and oscillatory index over 12 months. Safety and adherence will be monitored throughout the study, with additional evaluations of aneurysm wall enhancement using imaging. The total participation period includes treatment and follow-up extending to at least 24 months to observe lasting effects.
CONDITIONS
Brief Title
Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Vertebral and/or basilar artery dolichoectactic aneurysm not suitable for microsurgical or endovascular treatment
- Age greater than 18 years at time of first study drug administration
You will not qualify if you...
- Use of anti-TNF or other biologic medication within the previous 12 months
- Neutropenia (absolute neutrophil count < 1,500/microliter)
- Thrombocytopenia (platelets < 100,000)
- Anemia (hemoglobin < 8 g/dL)
- Liver function tests (AST or ALT) greater than or equal to 3 times the upper limit of normal
- Renal insufficiency (serum creatinine > 2.0 mg/dL)
- Positive tuberculosis test without completed or ongoing treatment
- History of tuberculosis infection without treatment or preventive therapy
- Presence of open leg ulcers
- Chronic or persistent infections including untreated hepatitis B, HIV, listeriosis, TB, or opportunistic infections
- Active or severe infection requiring hospitalization or intravenous treatment within 30 days prior to randomization
- Receipt of live vaccine within 4 weeks prior to randomization
- History of malignancy within 5 years except treated localized cervical carcinoma in situ or non-metastatic skin carcinoma
- Any medical condition that increases risk during study participation
- Women of childbearing potential who are sexually active and do not agree to use contraception during the study
- Pregnant or breastfeeding women
- Use of investigational agents within 4 weeks or 5 half-lives prior to randomization
- History of drug or alcohol abuse within 6 months prior to randomization
- Known allergy or hypersensitivity to any study products
- Psychiatric disorder preventing informed consent
- Inability or unwillingness to follow the protocol
- Unable to undergo magnetic resonance imaging (MRI)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive infliximab intravenously for their dolichoectactic vertebrobasilar aneurysms as per protocol.
Multiple infusions at weeks 0, 3, 7, and then every 8 weeks up to 12 months
Follow-up
Duration - Up to 24 months from treatment start
Participants undergo MR imaging assessments to evaluate aneurysm changes after treatment.
MR imaging at baseline, 12 months, and 24 months
Trial Site Locations
Total: 1 location
1
UCSF Medical Center
San Francisco, California, United States, 94143
Actively Recruiting
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Research Team
D
Daniel L Cooke, MD
J
Jonathan Graf, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Wells I Mangrum, John Huston, Michael J Link...
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https://pubmed.ncbi.nlm.nih.gov/23428244