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New ultrasound test could spot fatty liver in kids without needles or scans

NCT ID NCT06095479

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a special ultrasound technique can accurately measure liver fat in children with non-alcoholic fatty liver disease (NAFLD). Researchers compared ultrasound results to MRI scans in 90 children aged 6 to 18. If it works, this could offer a faster, radiation-free way to diagnose and monitor fatty liver in kids.

What this could mean

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

Active substance
2D ultrasound scan and MRI examination
What this could lead to
If successful, this could provide a simpler, cheaper way to diagnose fatty liver disease in children without needing MRI.
What could go wrong
This is a small, early feasibility study, not a treatment trial. The ultrasound method may not be accurate enough to replace MRI in practice.

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

90 people

The number who actually took part.

Started

Jul 2022

Finished

Dec 2024

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

6 to 17 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 age of 6-18 years old (≥6 \& \<18) who are able to provide assent to participate and have a parent/legal guardian who is able to provide informed consent for the subject to participate. * Subject 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 II 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: * Evidence of hepatotoxicity in the clinical judgment of the investigator. * History of chronic liver disease (e.g., viral hepatitis, cholestatic hepatitis, or autoimmune liver disease). * Use of drugs associated with hepatic steatosis1: amiodarone, aethotrexate, 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 and acetylsalicylic acid exceeding 150 mg/kg. Note: patients taking tetracycline (≤ 2 g/day), acetylsalicylic acid (≤150 mg/kg) are allowed to be enrolled. * Subjects with hepatic lesions that cannot be excluded from the imaging field during ultrasound LFQ data acquisition. * Subjects anticipated or planned to undergo any therapeutic intervention during enrollment period that, at discretion of the Investigator, may affect liver fat content (e.g., bariatric surgery, chemotherapy). * History of previous liver surgery or hepatic implants that, at the discretion of the Investigator, may adversely impact ultrasound or MRI image quality or the subject's eligibility to undergo ultrasound or MRI. * Subjects with unstable clinical status, late stages of a given disease, or unpredictable clinical course of a given disease. * Subjects with evidence of COVID-19 or with the substantial risk of COVID-19 infection.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, China, 200092, China

More trials for these conditions

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