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

NCT02511028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ferumoxytol

510mg (17mL) IV

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Daniel S Reich, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-27
Primary Completion
2018-08-01
Completion
2019-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02511028 on ClinicalTrials.gov