Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD
Recruiting now · Not applicable
Conditions studied: Metabolic Dysfunction-Associated Steatotic Liver Disease, Hepatic Steatosis, Liver Disease Parenchymal
In brief
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.
Key facts
- Study ID
- NCT07192159
- Run by
- Seoul National University Hospital
- People needed
- 62
- Starts
- 2025-06-24
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- southwoods imaging (Northeastern Ohio Radiology Research and Education Fund ) — Boardman, Ohio, United States (enrolling)
- Seoul National University Hospital — Seoul, Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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