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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeoul National University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of esophageal varices, ascites, hepatic encephalopathy, or acute biliary obstruction

History of liver cancer diagnosis or treatment

History of liver surgery

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Quantitative ultrasound (DeepUSFF)

    Device

    \*\*Novel Quantitative Ultrasound Technology Assessment\*\* This study evaluates Samsung Medison's proprietary DeepUSFF (Deep Learning-based Ultrasound Fat Fraction) technology, a next-generation quantitative ultrasound method for liver fat assessment that differs from conventional ultrasound approaches in several key aspects: advanced RF data analysis, proprietary technology, standardized protocol, direct MRI-PDFF correlation, specific MSALD poopulation and multicenter design.

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: Quantitative Ultrasound Fat Fraction AssessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Correlation between Ultrasound Fat Fraction and MRI-PDFF

earson correlation coefficient between quantitative ultrasound fat fraction (USFF) and MRI-PDFF

Time frame
At enrollment (single time point assessment)
2

Correlation between Ultrasound Fat Fraction and MRI-PDFF

Measure: Pearson correlation coefficient between quantitative ultrasound fat fraction (USFF) and MRI-PDFF

Time frame
At enrollment (single time point assessment)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Northeastern Ohio Radiology Research and Education Fund

Collaborator