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Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD

Recruiting

Evaluation of a Quantitative Ultrasound Model(DeepUSFF) for Liver Fat Quantification in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Multicenter Prospective Study Using MRI-PDFF as the Reference Standard

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Patients with clinically suspected MASLD based on abnormal ultrasound or liver function tests requiring liver ultrasound or MRI examination
* BMI ≥25 kg/m² or waist circumference \>90 cm (male) or \>80 cm (female), suggesting high likelihood of fatty liver disease
* Living liver transplant donors requiring preoperative liver ultrasound or MRI examination
* Age ≥18 years
* Understanding and signing informed consent

Exclusion Criteria:

* Significant alcohol consumption in the past 2 years:

Male: ≥30-60g/day average alcohol intake Female: ≥20-50g/day average alcohol intake

-Chronic liver disease:

Histological diagnosis of chronic liver disease HBsAg positive Anti-HCV positive Other suspected chronic liver diseases

-Liver failure:

Serum albumin \<3.2 g/dL INR \>1.3 Direct bilirubin \>1.3 mg/dL

* History of esophageal varices, ascites, hepatic encephalopathy, or acute biliary obstruction
* History of liver cancer diagnosis or treatment
* History of liver surgery
* Pregnancy
* Inability to obtain adequate liver ultrasound imaging:

Patient cooperation impossible Inadequate image acquisition as determined by investigator

-Inability to obtain adequate liver MRI imaging: Patient cooperation impossible Severe obesity preventing MRI examination MRI contraindications (cardiac pacemaker, etc.) Other factors preventing adequate imaging as determined by investigator

About the study

This multicenter prospective study aims to evaluate the correlation between quantitative ultrasound fat fraction (USFF) and MRI-PDFF (Proton Density Fat Fraction) for liver fat quantification in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The study will compare the diagnostic accuracy of quantitative ultrasound imaging against MRI-PDFF as the reference standard.

What is being tested

Sponsor: Seoul National University Hospital · Participants: 62 · Started: Jun 24, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07192159

Locations in the U.S.

Ohiosouthwoods imaging (Northeastern Ohio Radiology Research and Education Fund ), Boardman

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.