NCT07265011

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Jae Won Choi · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound and MRI	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.

Timeline

• Start date: 2024-12-31
• Primary completion: 2025-09-23
• Completion: 2025-09-23
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: South Korea