Quantitative US for Hepatic Steatosis

Seoul National University

Status: Completed

Conditions: Hepatic Steatosis

Treatments: Diagnostic Test: Quantitative ultrasound imaging parameter (QUS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04180631

SNUH-1808-155-967

Details and patient eligibility

About

The purpose of this study is to investigate the diagnostic performance of quantitative ultrasound imaging parameter for the assessment of hepatic steatosis in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients with clinically suspected non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), or living-donor candidates for liver transplantation, or volunteers
• Signed informed consent

Exclusion criteria

• chronic liver disease patients (serum HBsAg positive or anti-hepatitis C virus (HCV), histologic confirmation)
• chronic alcoholics
• serum alanine transaminase (ALT)>5 times the upper limit of normal within 3 months
• previous liver surgery
• acute hepatitis or bile duct obstruction

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

Quantitative ultrasound imaging parameter

Experimental group

Description:

Quantitative ultrasound imaging parameter (QUS)

Treatment:

Diagnostic Test: Quantitative ultrasound imaging parameter (QUS)