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A new MRI test could spot a hidden Heart-Lung danger in babies

NCT ID NCT06440408

Knowledge-focused Sponsor: Children's Hospital of Philadelphia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This pilot study tests whether a special MRI technique can measure wall shear stress—the force of blood against vein walls—in the pulmonary veins of infants. These veins carry blood from the lungs to the heart, and narrowing them (pulmonary vein stenosis) is a life-threatening condition. The study includes infants with normal hearts and those with pulmonary vein stenosis, using ferumoxytol as a contrast agent to enhance the images. If successful, this approach could lead to better screening and treatment guidance for at-risk infants.

What this could mean

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

Active substance
Ferumoxytol (contrast agent for cardiac MRI)
What this could lead to
If successful, this imaging technique could help identify infants at risk for pulmonary vein stenosis earlier and guide treatment decisions.
What could go wrong
This is a small pilot study with only 20 participants, so results may not apply broadly. The technique is experimental and may not reliably measure wall shear stress in all infants.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

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

Started

Sep 2024

Expected to finish

Jun 2028

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

Up to 18 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.

Normal (Controls) Subjects Inclusion Criteria 1. Males or Females less than 18 years of age. 2. Weight \> 3 kg. 3. Undergoing cMRI with ferumoxytol as part of clinical care. 4. Structurally normal heart (by echocardiography) with exception of small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies. 5. Parental/guardian permission (informed consent). Normal (Controls) Subjects Exclusion Criteria 1. Congenital heart disease (except small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies). 2. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 3. Patient not receiving ferumoxytol as part of their cMRI due to a known hypersensitivity to the drug, or a known diagnosis of iron overload. High-Risk Subject Inclusion Criteria 1. Males or Females less than 12 months of age. 2. Diagnosis of severe BPD (group 1) or TAPVC s/p repair (group 2). 3. Weight \> 3 kg. 4. Receiving respiratory support with an invasive airway (tracheostomy or endotracheal tube) (group 1 only). 5. Undergoing cMRI with ferumoxytol as part of clinical care (group 2 only). 6. Parental/guardian permission (informed consent). High-Risk Subject Exclusion Criteria 1. Congenital heart disease with single ventricle physiology. 2. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 3. Patient has a contraindication to ferumoxytol or any intravenous iron product such as a known hypersensitivity to the drug, or a known diagnosis of iron overload.

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia congenital pulmonary veins atresia or stenosis congenital total pulmonary venous return anomaly Stenosis, Pulmonary Vein

As listed by the trial registrant

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

Pulmonary vein stenosis

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

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.