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

NCT07192159 | Recruiting FDA Device

• 1 other identifier: 2503-162-1625
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Metabolic dysfunction-associated steatotic liver disease; Quantitative ultrasound; MRI-PDFF; Liver fat quantification; Hepatic steatosis; Deep learning

Outcome Measures

Primary Outcomes (2)

• Correlation between Ultrasound Fat Fraction and MRI-PDFF

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

  At enrollment (single time point assessment)

• Correlation between Ultrasound Fat Fraction and MRI-PDFF

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

  At enrollment (single time point assessment)

Study Arms (1)

Quantitative Ultrasound Fat Fraction Assessment

EXPERIMENTAL

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.

Device: Quantitative ultrasound (DeepUSFF)

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.

Quantitative Ultrasound Fat Fraction Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Understanding and signing informed consent

You may not qualify if:

• Significant alcohol consumption in the past 2 years:
• Male: ≥30-60g/day average alcohol intake Female: ≥20-50g/day average alcohol intake
• Chronic liver disease:
• Histological diagnosis of chronic liver disease HBsAg positive Anti-HCV positive Other suspected chronic liver diseases
• Liver failure:
• Serum albumin \<3.2 g/dL INR \>1.3 Direct bilirubin \>1.3 mg/dL
• History of esophageal varices, ascites, hepatic encephalopathy, or acute biliary obstruction
• History of liver cancer diagnosis or treatment
• History of liver surgery
• Pregnancy
• Inability to obtain adequate liver ultrasound imaging:
• Patient cooperation impossible Inadequate image acquisition as determined by investigator
• Inability to obtain adequate liver MRI imaging: Patient cooperation impossible Severe obesity preventing MRI examination MRI contraindications (cardiac pacemaker, etc.) Other factors preventing adequate imaging as determined by investigator

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Northeastern Ohio Radiology Research and Education Fund: collaborator

Study Sites (2)

southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )

Boardman, Ohio, 44512, United States

RECRUITING

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Related Publications (3)

• Xie WJ, Zhang B. Learning the Formation Mechanism of Domain-Level Chromatin States with Epigenomics Data. Biophys J. 2019 May 21;116(10):2047-2056. doi: 10.1016/j.bpj.2019.04.006. Epub 2019 Apr 11.

  PMID: 31053260 BACKGROUND

• Fan C, Shen M, Nussinov Z, Liu Z, Sun Y, Liu YY. Reply to: Deep reinforced learning heuristic tested on spin-glass ground states: The larger picture. Nat Commun. 2023 Sep 14;14(1):5659. doi: 10.1038/s41467-023-41108-w. No abstract available.

  PMID: 37709759 BACKGROUND

• Zhou G, Qin Y, Petticord D, Qiao X, Jiang M. Plant-ant interactions mediate herbivore-induced conspecific negative density dependence in a subtropical forest. Sci Total Environ. 2024 Jun 1;927:172163. doi: 10.1016/j.scitotenv.2024.172163. Epub 2024 Apr 1.

  PMID: 38569958 BACKGROUND

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Richard Gary Barr, MD

  Northeastern Ohio Radiology Research and Education Fund

  STUDY DIRECTOR

Central Study Contacts

Jeong Min Lee, MD

CONTACT

+82-2-2072-3154; jmsh@snu.ac.kr

Eun Jung Choi, RN

CONTACT

+82-2-2072-4177; eunjung0213@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Single Group Cross-Sectional Diagnostic Accuracy Study All enrolled participants will undergo both diagnostic procedures (quantitative ultrasound and MRI-PDFF) within a 7-day window to minimize temporal variation in liver fat content. This single-group design allows for direct paired comparison between the two diagnostic methods in the same participants, eliminating inter-subject variability and providing optimal conditions for correlation analysis.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: June 24, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months following article publication
• Access Criteria: Requests should be directed to the corresponding author with a detailed research proposal Data sharing agreements will be required Institutional review board approval may be required for secondary analyses

Locations

US (1); KR (1)