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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

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
Richard Barr, MD+13307706925rgbarr525@gmail.com

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