About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of esophageal varices, ascites, hepatic encephalopathy, or acute biliary obstruction
History of liver cancer diagnosis or treatment
History of liver surgery
Pregnancy
Trial design
Single group
Treatments tested in this trial
Quantitative ultrasound (DeepUSFF)
Device\*\*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.
Treatment groups
Trial outcomes
Primary outcomes
Correlation between Ultrasound Fat Fraction and MRI-PDFF
earson correlation coefficient between quantitative ultrasound fat fraction (USFF) and MRI-PDFF
Correlation between Ultrasound Fat Fraction and MRI-PDFF
Measure: Pearson correlation coefficient between quantitative ultrasound fat fraction (USFF) and MRI-PDFF
Sponsors and contacts
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Seoul National University Hospital
Lead sponsor
Northeastern Ohio Radiology Research and Education Fund
Collaborator