Hepatic Steatosis, Liver Disease Parenchymal, Metabolic Dysfunction-Associated Steatotic Liver Disease
Conditions
Keywords
Metabolic dysfunction-associated steatotic liver disease, Quantitative ultrasound, MRI-PDFF, Liver fat quantification, Hepatic steatosis, Deep learning
Brief 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.
Interventions
DEVICEQuantitative ultrasound (DeepUSFF)
\*\*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.
Sponsors
Northeastern Ohio Radiology Research and Education Fund
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single Group Cross-Sectional Diagnostic Accuracy Study All enrolled participants will undergo both diagnostic procedures (quantitative ultrasound and MRI-PDFF) within a 7-day window to minimize temporal variation in liver fat content. This single-group design allows for direct paired comparison between the two diagnostic methods in the same participants, eliminating inter-subject variability and providing optimal conditions for correlation analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between Ultrasound Fat Fraction and MRI-PDFF | At enrollment (single time point assessment) | earson correlation coefficient between quantitative ultrasound fat fraction (USFF) and MRI-PDFF |
Countries
South Korea, United States
Contacts
Primary ContactJeong Min Lee, MD
Backup ContactEun Jung Choi, RN
Outcome results
None listed