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Quantitative Ultrasound (RS85 and R20) for Liver Fat Quantification in MASLD Using MRI-PDFF as Reference
Sponsor: Seoul National University Hospital
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. ==\> V 4.0: Prospective multicenter study evaluating the correlation between Samsung Medison quantitative ultrasound (DeepUSFF) and MRI-PDFF in patients with MASLD across two ultrasound platforms (RS85 and R20). Total target enrollment 182 participants in two parallel device arms: RS85 arm (n=62; SNUH 31 + US site 31) and R20 arm (n=120; SNUH). Within the R20 arm, a paired-device substudy (n=60) evaluates interplatform reproducibility between R20 and RS85. Secondary objectives include intra- and inter-observer agreement of DeepUSFF on each platform.
Official title: Evaluation of a Quantitative Ultrasound Model for Liver Fat Quantification in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Multicenter Prospective Study Using MRI-PDFF as Reference, With Interplatform Reproducibility
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2025-06-24
Completion Date
2026-12-30
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Quantitative ultrasound (DeepUSFF)
\*\*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.
Locations (2)
southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )
Boardman, Ohio, United States
Seoul National University Hospital
Seoul, Seoul, South Korea