Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD

Seoul National University

Status: Enrolling

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease; Hepatic Steatosis; Liver Disease Parenchymal

Treatments: Device: Quantitative ultrasound (DeepUSFF)

Study type: Interventional

Funder types: Other

Identifiers

NCT07192159

2503-162-1625

Details and patient eligibility

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.

Full description

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common liver disease requiring accurate assessment for treatment planning and monitoring. While liver biopsy remains the gold standard, it is invasive with potential complications. MRI-PDFF has emerged as an accurate non-invasive method, but it is expensive and has limited accessibility. Quantitative ultrasound techniques using RF data have been developed to provide objective liver fat assessment.

Objective: To prospectively evaluate the correlation between quantitative ultrasound-derived fat fraction (DeepUSFF) and MRI-PDFF in patients with suspected MASLD across different ethnicities and varying degrees of hepatic steatosis.

Methods: This prospective multicenter study will recruit 62 patients (31 from each participating center) suspected of having MASLD. All participants will undergo both quantitative ultrasound examination and non-contrast liver MRI within one week. The primary endpoint is the correlation coefficient between ultrasound fat fraction and MRI-PDFF. Secondary endpoints include diagnostic accuracy metrics and inter-observer reproducibility.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Quantitative Ultrasound Fat Fraction Assessment

Experimental group

Description:

All enrolled participants undergo two non-invasive diagnostic imaging procedures within a 7-day window for direct comparison of liver fat quantification methods: 1. \*\*Quantitative Ultrasound Examination\*\*: Performed using Samsung RS85 ultrasound system with CA1-7S convex probe to obtain ultrasound fat fraction (DeepUSFF). The examination includes standard liver ultrasound assessment followed by quantitative fat fraction measurements in the right hepatic lobe (S5 or S8 segments). Multiple measurements (5 per session) are obtained during breath-holding to ensure reproducibility. Total examination time: approximately 10-15 minutes. 2. \*\*Non-contrast Liver MRI with PDFF\*\*: Magnetic resonance imaging with proton density fat fraction (MRI-PDFF) sequence and MR elastography performed within 7 days of the ultrasound examination. The MRI protocol includes breath-hold sequences (10-20 seconds each) for optimal image quality. Total examination time: approximately 15 minutes.

Treatment:

Device: Quantitative ultrasound (DeepUSFF)