Ultrasound-Based Estimation of Hepatic Steatosis in Pediatric MASLD

NCT07265011 | Completed

• 1 other identifier: SNUH-2312-148-1496
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MASLD; Pediatric

Keywords

MASLD; NAFLD; Fatty Liver; Pediatrics

Outcome Measures

Primary Outcomes (1)

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

  Reference standard: MRI-PDFF (percentage) \- intraclass correlation coefficient (ICC)

  At time of imaging (single visit)

Secondary Outcomes (3)

• Correlation Between AI-USFF and MRI-PDFF

  At time of imaging (single visit)

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

  At time of imaging (single visit)

• Inter-Vendor Reproducibility of AI-USFF

  At time of imaging (single visit)

Study Arms (1)

Liver Ultrasound and MRI

EXPERIMENTAL

Diagnostic Test: Ultrasound and MRI

Interventions

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.

Liver Ultrasound and MRI

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jae Won Choi: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

Ultrasonography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: December 31, 2024
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

KR (1)