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

NCT02511028 | Completed Phase 1 FDA Drug

• 2 other identifiers: 15015615-N-0156
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Keywords

MRI; Multiple Sclerosis; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• change in gradient-echo T2*-weighted signal in an iron-rich brain structure, the globus pallidus

  determine if ferumoxytol induces long-lasting brain signal intensity changes in HV and MS

  6 months following ferumoxytol administration

Study Arms (1)

ferumoxytol

EXPERIMENTAL

A 510 mg dose (17 mL) of ferumoxytol diluted in 50 mL of 0.9% normal saline will be intravenously infused over 17 minutes

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

510mg (17mL) IV

ferumoxytol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 70 (inclusive)
• able to give informed consent
• brain MRI within 2 years of study enrollment that shows no clinically significant abnormalities, in the judgment of a board-certified and NIH-credentialed neuroradiologist
• age between 18 and 70, inclusive
• able to give informed consent
• diagnosis of multiple sclerosis according to revised McDonald Criteria

You may not qualify if:

• screening labs demonstrating any value for hepatic or renal function levels out of the range of normal, to include AST, ALT, bilirubin, alkaline phosphatase, creatinine, eGFR
• evidence of polycythemia vera with hemoglobin levels more than 1 standard deviation above the NIH laboratory s normal level
• iron overload syndromes, including hemochromatosis, or subjects with evidence of iron overload with a baseline ferritin level greater than 370 ng/ml and percent saturation of transferrin level greater than 40%.
• previous or current alcohol and/or substance abuse per medical history or medical records
• medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed)
• psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected
• pregnancy or current breastfeeding
• reported history of clinically significant impaired hearing, because people with impaired hearing are at increased risk of sound-induced damage from the MRI scanner
• known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions, anaphylaxis, to any drug
• clinically significant medical or neurological disorders that, in the judgment of the investigators might expose the patient to undue risk of harm confound study outcomes or prevent the participant from completing the study; examples of such conditions include but are not limited to diagnosis of certain types of cancer, cardiopulmonary conditions such as congestive heart failure, or uncontrolled hypertension
• or more gadolinium-enhancing lesions on the screening scan

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• National Institutes of Health Clinical Center (CC): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Daniel S Reich, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 29, 2015
• Study Start: November 27, 2015
• Primary Completion: August 1, 2018
• Study Completion: January 29, 2019
• Last Updated: April 20, 2026

Record last verified: 2025-09-17

Locations

US (1)