NCT07265011Completed
Ultrasound-Based Estimation of Hepatic Steatosis in Pediatric MASLD
Prospective Validation of an AI-Driven Ultrasound-Based Method for Estimating Hepatic Steatosis Using MRI-Derived Fat Fraction as Reference in Pediatric Metabolic Dysfunction-Associated Steatotic Liver Disease
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
The purpose of this study is to validate an artificial intelligence (AI)-based algorithm that estimates hepatic steatosis using ultrasound (US) B-mode images in pediatric participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The MRI proton density fat fraction (MRI-PDFF) serves as the reference standard for hepatic fat quantification.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 23 Nov 2025
- Start date
- 31 Dec 2024
- Primary completion date
- 23 Sept 2025
- Lead sponsor
- Jae Won Choi
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07265011
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 31 Dec 2024 to the primary completion date, 23 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- unable to cooperate with imaging procedures
- parent or legal guardian unable to understand the study explanation
- contraindications to MRI
- determined by the investigator to be otherwise unsuitable for participation after consultation
Who the study is looking for
- participants aged 8 to 18 years clinically indicated for liver ultrasound examination to evaluate hepatic steatosis
- participants with suspected or known metabolic dysfunction-associated steatotic liver disease (MASLD)
- able to understand the study purpose and provide written informed consent (from both participant and legal guardian).
- agree to undergo same-day liver MRI examination in addition to the ultrasound
Age in the registry: 8 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.