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Could an ultrasound replace MRI for heart monitoring?

NCT ID NCT05186415

Knowledge-focused Sponsor: Nemours Children's Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using a contrast dye during 3D ultrasound can accurately measure the size and function of the right heart chamber in people who had surgery for congenital heart disease. 25 participants received an injection of Lumason (an ultrasound contrast agent) and then had a 3D echocardiogram. The results were compared to standard cardiac MRI measurements to see if the ultrasound method is reliable enough for routine use.

What this could mean

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

Active substance
Sulfur hexafluoride lipid microspheres (Lumason)
What this could lead to
If successful, this could provide a faster, cheaper, and safer way to monitor heart function in people with repaired congenital heart disease, reducing the need for frequent MRIs.
What could go wrong
This is a small, early-phase study with only 25 participants, so results may not apply to everyone. The contrast agent also carries a small risk of allergic reactions.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

25 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2024

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

11 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: 1. All patients aged 11 or greater with repaired congenital heart disease and residual pulmonary insufficiency who are referred to Nemours A.I. DuPont Hospital for Children for clinically indicated cardiac MRI will be eligible for inclusion. 2. Informed written consent of parent or legal guardian. 3. Informed written assent of subject, if appropriate. Exclusion Criteria: 1. Any patients in which Lumason is contraindicated (i.e. prior anaphylactoid reaction) will be ineligible for the clinical ultrasound and ineligible for the study. 2. History of allergic reaction to Lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid) 3. Pregnant women will be excluded from the study as well since Lumason has not been studied in pregnancy.

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Conditions

The condition(s) this trial relates to.

pulmonary valve insufficiency respiratory failure tetralogy of fallot

As listed by the trial registrant

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

Pulmonary insufficiency Tetralogy of fallot

Contacts and locations

Locations

  • Nemours Childrens Hospital

    Wilmington, Delaware, 19803, United States

More trials for these conditions

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