In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging
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. \<TAB\>- 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.
Timeline
- Start
- 2015-11-27
- Primary completion
- 2018-08-01
- Completion
- 2019-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferumoxytol | Diagnostic / imaging agent | 510 mg | Intravenous |