Iron nanoparticle could light up MS brain inflammation on MRI
NCT ID NCT02511028
First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 19 times
Summary
This early-phase study tested whether ferumoxytol, an iron-based contrast agent, can help MRI scans better detect inflammation in the brains of people with multiple sclerosis (MS). Fourteen participants (some with MS, some healthy) received a single IV dose of ferumoxytol and had multiple 7-tesla MRI scans over six months. The goal was to see if the drug causes lasting changes in brain signals and whether it can highlight areas of inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ferumoxytol (an iron-based contrast agent given by IV)
- What this could lead to
- If successful, ferumoxytol could become a new way to see inflammation in the brains of people with multiple sclerosis using MRI.
- What could go wrong
- This is a very small, early-phase study with only 14 participants. It is testing imaging, not treatment, so it won't directly improve MS symptoms. Ferumoxytol may cause long-lasting MRI signal changes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
14 people
The number who actually took part.
- Started
-
Nov 2015
- Finished
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Jan 2019
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: HEALTHY VOLUNTEER INCLUSION CRITERIA * 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 PATIENT INCLUSION CRITERIA * age between 18 and 70, inclusive * able to give informed consent * diagnosis of multiple sclerosis according to revised McDonald Criteria EXCLUSION CRITERIA: GENERAL EXCLUSION CRITERIA: * 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 ADDITIONAL PATIENT EXCLUSION CRITERION: -4 or more gadolinium-enhancing lesions on the screening scan
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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