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

Last updated: September 17, 2025
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatic Fibrosis

Treatment

Quantitative ultrasound (DeepUSFF)

Clinical Study ID

NCT07192159
2503-162-1625
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with clinically suspected MASLD based on abnormal ultrasound or liverfunction tests requiring liver ultrasound or MRI examination

  • BMI ≥25 kg/m² or waist circumference >90 cm (male) or >80 cm (female), suggestinghigh likelihood of fatty liver disease

  • Living liver transplant donors requiring preoperative liver ultrasound or MRIexamination

  • Age ≥18 years

  • Understanding and signing informed consent

Exclusion

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 biliaryobstruction

  • 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

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: Quantitative ultrasound (DeepUSFF)
Phase:
Study Start date:
June 24, 2025
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Seoul National University Hospital

    Seoul 1835848, Seoul 1835847 03080
    South Korea

    Active - Recruiting

  • southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )

    Boardman 5147784, Ohio 5165418 44512
    United States

    Active - Recruiting

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