Recruiting

Ultrasound vs. MRI-PDFF

Sponsor:

Seoul National University Hospital

Code:

NCT07192159

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Hepatic Steatosis

Liver Disease Parenchymal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quantitative ultrasound (DeepUSFF)

Study Details

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

Study ID

NCT07192159

Start date

Jun 24, 2025

Status verified date

Sep, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

62 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Correlation between Ultrasound Fat Fraction and MRI-PDFF [ Time Frame: At enrollment (single time point assessment) ]
  • Correlation between Ultrasound Fat Fraction and MRI-PDFF [ Time Frame: At enrollment (single time point assessment) ]

Central Contacts and Locations

Central contacts

Jeong Min Lee, MD

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

Eun Jung Choi, RN

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

Locations

southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )

Recruiting

Boardman, Ohio, United States, 44512

Contacts

Richard Barr, MD

+13307706925rgbarr525@gmail.com

More Information

Sponsor

Seoul National University Hospital

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seoul National University Hospital on 2025-09-25.