Treatment Targets for Inflamed Intracranial Atherosclerosis on Vessel Wall MRI

NCT03084523 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2000031256
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Intracranial atherosclerosis (ICAS) accounts for 10 to 40%, depending on ethnicity, of the 700,000 ischemic strokes in the United States every year. The annual rate of recurrent stroke in patients with optimally treated ICAS remains more than twice the average of other stroke etiologies (12.5% vs. 5). A robust literature has established that vessel wall magnetic resonance imaging (vwMRI) of extracranial carotid vessel wall enhancement (VWE) can predict stroke, independent of stenosis. VWE has been reported in symptomatic ICAS, but the role of local and systemic inflammation is unknown. Inflammatory biomarkers are elevated in symptomatic extracranial atherosclerosis, but the association with vwMRI findings in ICAS has not yet been explored. VWE is typically demonstrated by the uptake of gadolinium MRI contrast into the aneurysm wall or atherosclerotic plaque. A novel MRI contrast agent, ferumoxytol, allows multi-contrast weighting on T1w and T2w images and provides important insight into the role of local vessel wall inflammation by accumulating in macrophages on delayed T2\* sequences. To identify effective prevention and treatment strategies for cerebrovascular disease, we need to critically evaluate vwMRI techniques, determine VWE prevalence, and explore the link between VWE and inflammation.

Conditions

Stroke; Intracranial Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Vessel Wall Enhancement with Gadolinium compared to Vessel Wall Enhancement with Ferumoxytol in intracranial atherosclerosis (ICAS) group.

  Both patient groups will have a high-resolution vessel wall enhancement-gadolinium MRI at baseline with a delayed high-resolution vessel wall enhancement-Ferumoxytol MRI. Prevalence will be analyzed between the different participants in each group. Hypothesis: Participants with intracranial atherosclerosis will have a high prevalence of vessel wall enhancement.

  1 year

Study Arms (1)

1

EXPERIMENTAL

80 patients with intracranial atherosclerosis

Drug: Ferumoxytol Injectable Product

Interventions

Ferumoxytol Injectable Product DRUG

Patients will be administered a single dose of ferumoxytol as an MRI contrast

Also known as: Feraheme

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• intracranial atherosclerosis (stenosis ≥50%)
• recent ischemic stroke (less than or equal to 14 days)

You may not qualify if:

• Less than 18 years old
• Documented history of atrial fibrillation
• Carotid stenosis greater than 70%
• Pregnant women
• Contrast allergy
• Acute or chronic kidney disease with glomerular filtration rate\<30 ml/min/1.73m2
• Intravenous iron sensitivity
• Serum ferritin and transferrin saturation above age-adjusted upper limit of normal. If serum ferritin is above normal, but transferrin saturation is normal, the patient is not excluded.
• Pacemaker or other MRI contraindications

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Stroke; Intracranial Arteriosclerosis

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Adam de Havenon, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: March 21, 2017
• Study Start: April 26, 2017
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-08

Locations

US (1)