Actively Recruiting
Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD
Led by Seoul National University Hospital · Updated on 2025-09-25
62
Participants Needed
2
Research Sites
53 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
N
Northeastern Ohio Radiology Research and Education Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with suspected MASLD based on abnormal ultrasound or liver function tests needing liver ultrasound or MRI
- Body mass index of 25 kg/m² or higher, or waist circumference over 90 cm for males or 80 cm for females
- Living liver transplant donors needing preoperative liver ultrasound or MRI
- Age 18 years or older
- Able to understand and sign informed consent
You will not qualify if you...
- Significant alcohol use in past 2 years: males exceeding 30-60g/day, females exceeding 20-50g/day
- Chronic liver disease diagnosed by biopsy or positive hepatitis B or C tests
- Liver failure with serum albumin under 3.2 g/dL, INR over 1.3, or direct bilirubin over 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
- Unable to obtain adequate liver ultrasound due to poor cooperation or image quality
- Unable to obtain adequate liver MRI due to poor cooperation, severe obesity, MRI contraindications, or other imaging issues
AI-Screening
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Trial Site Locations
Total: 2 locations
1
southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )
Boardman, Ohio, United States, 44512
Actively Recruiting
2
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Actively Recruiting
Research Team
J
Jeong Min Lee, MD
CONTACT
E
Eun Jung Choi, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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