Quantitative Ultrasound (RS85 and R20) for Liver Fat Quantification in MASLD Using MRI-PDFF as Reference

Study acronym: DeepUSFF
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Enrollment increased: 62 → 182 participants Show 8 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Jun 30, 2026 to Dec 30, 2026
    • Trial arms changed: 1 → 2
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints expanded, about 39 words
    • Study description expanded, about 78 words
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 5 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07192159
Lead Sponsor Seoul National University Hospital
Collaborators: Northeastern Ohio Radiology Research and Education Fund
Conditions
(from sponsor)		 Metabolic Dysfunction-Associated Steatotic Liver Disease, Hepatic Steatosis, Liver Disease Parenchymal
Related terms Fatty Liver
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov