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Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD
RECRUITINGN/ASponsored by Seoul National University Hospital
Actively Recruiting
PhaseN/A
SponsorSeoul National University Hospital
Started2025-06-24
Est. completion2026-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07192159
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions4
Hepatic SteatosisLiver DiseaseLiver Disease ParenchymalMetabolic Dysfunction-Associated Steatotic Liver Disease
Locations1 site
southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )
Boardman, Ohio, 44512
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Actively Recruiting
PhaseN/A
SponsorSeoul National University Hospital
Started2025-06-24
Est. completion2026-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07192159