Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD
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
Seoul National University Hospital
62 participants
Jun 24, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria13
- 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
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Interventions
\*\*Novel Quantitative Ultrasound Technology Assessment\*\* This study evaluates Samsung Medison's proprietary DeepUSFF (Deep Learning-based Ultrasound Fat Fraction) technology, a next-generation quantitative ultrasound method for liver fat assessment that differs from conventional ultrasound approaches in several key aspects: advanced RF data analysis, proprietary technology, standardized protocol, direct MRI-PDFF correlation, specific MSALD poopulation and multicenter design.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07192159