MedTrace Logo

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

NCT07192159 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-09-25

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Northeastern Ohio Radiology Research and Education Fund

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jeong Min Lee, MD · Seoul National University Hospital

  • Richard Gary Barr, MD · Northeastern Ohio Radiology Research and Education Fund

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2026-04-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07192159 on ClinicalTrials.gov