New ultrasound test could spot fatty liver in kids without needles or scans
NCT ID NCT06095479
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
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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
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90 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Dec 2024
- Lead sponsor
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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
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6 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092, China
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Other studies related to the condition(s) this trial covers.
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