In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging

• Status: Completed
• Trial end date: 2019-01-29

Summary

Background:

• Contrast agents help things show up better on magnetic resonance imaging (MRI) scans. Researchers want to see if the drug ferumoxytol is a good contrast agent. They want to determine that it does not cause prolonged MRI changes in the brain and to see if it helps identify inflammation in multiple sclerosis

Objective:

• To learn how ferumoxytol can be used to image inflammation in multiple sclerosis (MS).

Eligibility:

• Adults ages 18 70 who have MS.

• Healthy volunteers ages 18 70.

Design:

• Participants will have 5 clinic visits over 6 months.

• Participants will be screened with a medical history, neurological exam, and blood draw. Full clinical measures will be obtained.

• Participants will have a 7 tesla brain MRI scan that may include gadolinium contrast agent. The MRI is a metal cylinder in a strong magnetic field. The participant will lie on a table that can slide in and out of the cylinder.

• During visit 2, ferumoxytol with be given through a catheter (a thin plastic tube) that is inserted with a needle into a vessel in the arm.- Participants will then have a 7 tesla MRI scan of the brain..

• At each of the next 3 clinic visits, participants will have a 7 tesla brain MRI and have blood drawn. The MRIs may include gadolinium.

• Participants may have a full neurologic exam at these visits. At the final visit, full clinical measures will be obtained.

• Participants may have more MRI scans if a 6-month MRI shows ferumoxytol still in the brain. Phase: Phase 1

Details

• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health Clinical Center (CC)
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health Clinical Center (CC)
• Treatments: Dextrans; Ferrosoferric Oxide