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

NCT ID: NCT07192159

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-24
• Study Completion Date: 2026-06-30

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.

Detailed Description

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common liver disease requiring accurate assessment for treatment planning and monitoring. While liver biopsy remains the gold standard, it is invasive with potential complications. MRI-PDFF has emerged as an accurate non-invasive method, but it is expensive and has limited accessibility. Quantitative ultrasound techniques using RF data have been developed to provide objective liver fat assessment.

Objective: To prospectively evaluate the correlation between quantitative ultrasound-derived fat fraction (DeepUSFF) and MRI-PDFF in patients with suspected MASLD across different ethnicities and varying degrees of hepatic steatosis.

Methods: This prospective multicenter study will recruit 62 patients (31 from each participating center) suspected of having MASLD. All participants will undergo both quantitative ultrasound examination and non-contrast liver MRI within one week. The primary endpoint is the correlation coefficient between ultrasound fat fraction and MRI-PDFF. Secondary endpoints include diagnostic accuracy metrics and inter-observer reproducibility.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Quantitative ultrasound (DeepUSFF)

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northeastern Ohio Radiology Research and Education Fund

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong Min Lee

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Richard Gary Barr, MD

Role: STUDY_DIRECTOR

Northeastern Ohio Radiology Research and Education Fund

Locations

southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )

Boardman, Ohio, United States

Site Status: RECRUITING

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status: RECRUITING

Countries

United States; South Korea

Central Contacts

Jeong Min Lee, MD

Role: CONTACT

jmsh@snu.ac.kr

+82-2-2072-3154

Eun Jung Choi, RN

Role: CONTACT

eunjung0213@snu.ac.kr

+82-2-2072-4177

Facility Contacts

Richard Barr, MD

Role: primary

rgbarr525@gmail.com

+13307706925

Jeong Min Lee, MD

Role: primary

JMSH@SNU.AC.KR

821036783860

References

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Reference Type: BACKGROUND

PMID: 31053260 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37709759 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38569958 (View on PubMed)

Other Identifiers

2503-162-1625

Identifier Type: -

Identifier Source: org_study_id