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Completed

NCT Number: NCT07265011

Ultrasound-Based Estimation of Hepatic Steatosis in Pediatric MASLD

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.

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Key information

Conditions

MASLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Pediatric

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ultrasound and MRI

Diagnostic Test

Participants undergo same-day liver imaging including conventional B-mode ultrasound, quantitative ultrasound, and magnetic resonance imaging (MRI).

Conventional Ultrasound: B-mode imaging performed on three ultrasound systems (Canon Aplio i800, Philips EPIQ, and Supersonic AIXPLORER) to acquire grayscale liver images for artificial intelligence (AI) analysis.

Quantitative Ultrasound: Attenuation imaging (ATI) and shear wave elastography/dispersion measurements performed to assess hepatic fat and stiffness.

MRI: Proton density fat fraction (PDFF) measurement used as the reference standard for hepatic steatosis quantification.

All imaging is performed on the same day for each participant to ensure temporal consistency across modalities and vendors.

Primary outcomes

  1. Agreement Between AI-Predicted Ultrasound Fat Fraction (AI-USFF) and MRI Proton Density Fat Fraction (MRI-PDFF)

    Time frame: At time of imaging (single visit)

    Reference standard: MRI-PDFF (percentage)

    • intraclass correlation coefficient (ICC)

Secondary outcomes

  1. Correlation Between AI-USFF and MRI-PDFF

    Time frame: At time of imaging (single visit)

    Reference standard: MRI-PDFF (percentage)

    • Pearson correlation coefficient (r)

  2. Diagnostic Performance of AI-USFF for MRI-Based Hepatic Steatosis Grades

    Time frame: At time of imaging (single visit)

    The diagnostic performance of AI-USFF for detecting mild, moderate, and severe hepatic steatosis, as defined by MRI-PDFF thresholds, will be evaluated using area under the receiver operating characteristic curve (AUC).

  3. Inter-Vendor Reproducibility of AI-USFF

    Time frame: At time of imaging (single visit)

    Reproducibility of AI-USFF across the three ultrasound systems are assessed using the intraclass correlation coefficient (ICC [2,k]).

Sponsors and collaborators

Lead sponsor

Jae Won Choi

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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