Ultrasound-Based Estimation of Hepatic Steatosis in Pediatric MASLD

NCT ID: NCT07265011

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-09-23

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Liver Ultrasound and MRI

Group Type: EXPERIMENTAL

Ultrasound and MRI

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jae Won Choi

OTHER

Sponsor Role: lead

Responsible Party

Jae Won Choi

Clinical Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUH-2312-148-1496

Identifier Type: -

Identifier Source: org_study_id