NCT07192159Active, not recruiting

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

Evaluation of a Quantitative Ultrasound Model for Liver Fat Quantification in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Multicenter Prospective Study Using MRI-PDFF as Reference, With Interplatform Reproducibility

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 182 (estimated)
First submitted: 17 Sept 2025
Start date: Jun 2025
Primary completion date: Apr 2026
Lead sponsor: Seoul National University Hospital
Diseases: Fatty liver disease (MASLD/MASH)
NCT number: NCT07192159

What you commit to

Study type: Interventional
Planned participants: 182
From Jun 2025 to the primary completion date, Apr 2026
2 sites in 2 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

History of esophageal varices, ascites, hepatic encephalopathy, or acute biliary obstruction
History of liver cancer diagnosis or treatment
History of liver surgery
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

Lab values

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

Other

Pregnancy

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Seoul National University Hospital Coordinator of this site? Confirm its status	Seoul	South Korea	Unknown status
southwoods imaging (Northeastern Ohio Radiology Research and Education Fund ) Coordinator of this site? Confirm its status	Boardman	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.