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Can an Iron-Based dye reveal hidden inflammation in progressive MS?

NCT ID NCT05357833

Diagnosis Sponsor: University of Utah Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This pilot study tests whether a special MRI contrast agent called ferumoxytol can highlight areas of active inflammation in the brains of people with secondary progressive multiple sclerosis (SPMS). The goal is to see if this imaging method can distinguish chronic-active lesions—which may drive worsening disability—from inactive ones. Adults aged 35 to 65 with SPMS will receive an intravenous infusion of ferumoxytol and a standard contrast agent, then undergo MRI scans before and after to measure signal changes. The study also checks the safety and tolerability of ferumoxytol in this group.

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 MRI contrast agent) and gadoteridol (a standard MRI contrast agent)
What this could lead to
If successful, this could lead to a new MRI technique to identify active inflammation in progressive MS, helping doctors monitor disease and potentially guide treatment decisions.
What could go wrong
This is a very small early-phase pilot study, so results may not be conclusive. The imaging marker may not reliably distinguish active from inactive lesions, and ferumoxytol carries risks like allergic reactions or iron overload.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

11 people

The number who actually took part.

Started

Jun 2022

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 65 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.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults age 35 to 65 years 2. Clinically diagnosed with secondary progressive multiple sclerosis (SPMS) (2017 McDonald Criteria) 3. Worsening 25 foot walk time (worsening SPMS cohort) over the preceding 2 years. 4. Ambulatory with ability to walk at least 20 meters without rest, with or without aid 5. Ability and willingness to attend study visits and complete the study Exclusion Criteria: 1. Clinically diagnosed with relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), clinical isolated syndrome (CIS), or radiologically isolated syndrome (RIS) 2. Clinical MS relapse and/or new MRI lesion(s) within the preceding 2 years 3. Positive pregnancy test 4. Gadolinium contrast allergy 5. Acute or chronic kidney disease with eGFR \<30 ml/min/1.73m2 6. Pacemaker or other MRI contraindications per American College of Radiology guidelines 7. Intravenous iron sensitivity 8. Serum ferritin and transferrin saturation above age-adjusted upper limit of normal (if serum ferritin is above normal, but transferrin saturation is normal, the subject is NOT excluded)

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis multiple sclerosis secondary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis Multiple sclerosis, secondary progressive Secondary progressive multiple sclerosis

Contacts and locations

Locations

  • University of Utah Health Imaging and Neurosciences Center

    Salt Lake City, Utah, 84108, United States

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