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Could a simple ultrasound replace MRI for fatty liver in kids?

NCT ID NCT04800094

Diagnosis Sponsor: Philips Clinical & Medical Affairs Global 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new ultrasound software that measures liver fat in children and teens aged 5 to 21 with or at risk for fatty liver disease. Researchers compared the ultrasound results to standard MRI scans to see if the ultrasound could accurately detect liver fat. If it works, this could offer a quicker, cheaper way to diagnose and monitor the condition without the need for MRI.

What this could mean

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

Active substance
Investigational Liver Fat Quantification Software (ultrasound device)
What this could lead to
If successful, this could provide a faster, cheaper, and radiation-free way to diagnose and monitor fatty liver disease in children using ultrasound instead of MRI.
What could go wrong
This is a small pilot study with only 30 participants, so results may not apply to everyone. The ultrasound method is still experimental and needs more testing before it can replace MRI.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Mar 2021

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

5 to 21 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: * Subjects at least 5 years old up through and including 21 years old who are able to provide informed consent to participate or have a legal representative/parent/legal guardian who is able to provide informed consent for the subject to participate. * Subjects must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination. In addition, at least one of the following criteria must also be met: * Overweight or obese (BMI-for-age ≥ 85th percentile). * Diagnosed with Type 2 diabetes per standard clinical guidelines. * Diagnosed with hypercholesterolemia per standard clinical guidelines. * Diagnosed with or clinically suspected of having NAFLD/NASH based on previous medical record, medical imaging, liver biopsy, and/or laboratory testing. Exclusion Criteria: * History of moderate/heavy/binge alcohol consumption exceeding NIAAA guidelines. * Evidence of hepatotoxicity or cirrhosis in the clinical judgment of the investigator. * History of chronic liver disease other than NAFLD (e.g., viral, cholestatic, or autoimmune). * Use of drugs associated with hepatic steatosis: * Amiodarone * Methotrexate * Nucleoside reverse transcriptase inhibitors (didanosine, stavudine) * Valproic acid * Dexamethasone * Tamoxifen * 5-FU-based adjuvant chemotherapy * Apo-B inhibitors (mipomersen, lomitapide) * Tetracycline exceeding 2 g/day * Acetylsalicylic acid exceeding 150 mg/kg

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases liver disorder metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Non - alcoholic steatohepatitis Non-alcoholic fatty liver disease

Contacts and locations

Locations

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

More trials for these conditions

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