Status:
RECRUITING
Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Northeastern Ohio Radiology Research and Education Fund
Conditions:
Metabolic Dysfunction-Associated Steatotic Liver Disease
Hepatic Steatosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 patie...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT07192159
Start Date
June 24 2025
End Date
June 30 2026
Last Update
September 25 2025
Active Locations (2)
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1
southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )
Boardman, Ohio, United States, 44512
2
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080