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Iron-Based MRI dye could replace risky gadolinium for vein scans

NCT ID NCT07452250

Diagnosis Sponsor: Min Zhou Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new MRI contrast agent called ferumoxytol, made from iron nanoparticles, to see if it can safely and effectively image veins in people with vein diseases. Current dyes can be risky for patients with kidney problems, but ferumoxytol may be safer and last longer in the blood. The trial will enroll 50 adults and give them increasing doses to find the smallest amount needed for clear images.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferumoxytol injection (iron-based contrast agent)
What this could lead to
If successful, this could provide a safer alternative to current MRI dyes for diagnosing vein problems, especially for patients with kidney issues.
What could go wrong
This is a small, early-phase trial (50 people) focused on imaging quality, not treatment. The iron-based dye may still cause allergic reactions or not work as well as hoped.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2026

An estimate. End dates often move.

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

18 years and older

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: * Age \>= 18 years. * Suspected or preliminarily diagnosed venous structural abnormalities (e.g., lower-extremity veins, central veins) or venous circulation disorders requiring Fe-MRV evaluation. * Able and willing to provide written informed consent. Exclusion Criteria: * History of allergy/hypersensitivity to iron or dextran, or known allergy-prone constitution. * Currently receiving other oral or intravenous iron products. * Hemosiderosis or hemochromatosis. * Prior hypersensitivity reaction to intravenous iron products, or any condition associated with iron overload. * Unable to undergo MRI for psychological reasons (e.g., claustrophobia) or physical reasons (e.g., non-MRI-compatible metallic implants/foreign bodies). * End-stage disease or life expectancy \< 1 year. * Pregnant women. * Any other condition judged by the investigator to make the participant unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

vein disorder

As listed by the trial registrant

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

Venous diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    RECRUITING

    Nanjing, Jiangsu, 210008, China