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

Part of paid clinical trials in Boardman, Ohio.

Sponsor
Seoul National University Hospital
Study ID
NCT07192159
Status
Recruiting
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Conditions

  • Hepatic Steatosis
  • Liver Disease Parenchymal
  • Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 24, 2025
Status verified
Sep 2025
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Quantitative Ultrasound Fat Fraction Assessment
    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.

Primary Outcome Measure

Correlation between Ultrasound Fat Fraction and MRI-PDFF [ Time Frame: At enrollment (single time point assessment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )BoardmanOhio44512
Richard Barr, MD
[email protected]
+13307706925

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southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )· Boardman, OH

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