Ultrasound-Based Estimation of Hepatic Steatosis in Pediatric MASLD

Jae Won Choi

Status: Completed

Conditions: MASLD; Pediatric

Treatments: Diagnostic Test: Ultrasound and MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT07265011

SNUH-2312-148-1496

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Liver Ultrasound and MRI

Experimental group

Treatment:

Diagnostic Test: Ultrasound and MRI