NCT07192159NARecruiting

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

Seoul National University Hospital

Start Date

6/24/2025

Completion Date

6/30/2026

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.

Detailed Description

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common liver disease requiring accurate assessment for treatment planning and monitoring. While liver biopsy remains the gold standard, it is invasive with potential complications. MRI-PDFF has emerged as an accurate non-invasive method, but it is expensive and has limited accessibility. Quantitative ultrasound techniques using RF data have been developed to provide objective liver fat assessment. Objective: To prospectively evaluate the correlation between quantitative ultrasound-derived fat fraction (DeepUSFF) and MRI-PDFF in patients with suspected MASLD across different ethnicities and varying degrees of hepatic steatosis. Methods: This prospective multicenter study will recruit 62 patients (31 from each participating center) suspected of having MASLD. All participants will undergo both quantitative ultrasound examination and non-contrast liver MRI within one week. The primary endpoint is the correlation coefficient between ultrasound fat fraction and MRI-PDFF. Secondary endpoints include diagnostic accuracy metrics and inter-observer reproducibility.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Quantitative ultrasound (DeepUSFF)

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Conditions

Metabolic Dysfunction-Associated Steatotic Liver DiseaseHepatic SteatosisLiver Disease Parenchymal

Locations

southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )

Boardman, Ohio 44512

United States

Seoul National University Hospital

Seoul, Seoul 03080

South Korea