Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD
Sponsored by Seoul National University Hospital
About this trial
Last updated 8 months ago
Study ID
2503-162-1625
Status
Recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Started a year ago
What is this trial 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.
What are the participation requirements?
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