Metabolic Dysfunction-Associated Steatotic Liver DiseaseDeepUSFFNCT07192159
Quantitative Ultrasound (RS85 and R20) for Liver Fat Quantification in MASLD Using MRI-PDFF as Reference
A study testing Quantitative ultrasound (DeepUSFF) in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Hepatic Steatosis, run by Seoul National University Hospital at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Hepatic Steatosis, Liver Disease Parenchymal
- What is being tested?
- Quantitative ultrasound (DeepUSFF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Jun 2025to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )
Boardman, Ohio, 44512
About this study
Official title: 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
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.
Read the 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.
==> V 4.0: Two-platform design (RS85 and R20). Each participant undergoes quantitative ultrasound (DeepUSFF and shear-wave elastography) on the assigned device and non-contrast liver MRI (MRI-PDFF and MRE) within ±7 days. Per-platform reproducibility: intra-observer (two sessions, all participants on the assigned device) and inter-observer (two operators, two measurements each, n=20 per device arm). Interplatform reproducibility substudy: a subset of 60 R20-arm participants additionally undergo RS85 scanning on the same visit (two measurements per device) for paired R20-RS85 comparison.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Hepatic Steatosis, Liver Disease Parenchymal
- Being tested
- Quantitative ultrasound (DeepUSFF)
- Keywords
- Metabolic dysfunction-associated steatotic liver disease, Quantitative ultrasound, MRI-PDFF, Liver fat quantification, Hepatic steatosis, Deep learning
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| RS85 Quantitative Ultrasound Arm | 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. Receives: Device: Quantitative ultrasound (DeepUSFF) |
| R20 Quantitative Ultrasound Arm (with Interplatform Substudy) | Experimental | Participants (n=120; SNUH) undergo quantitative ultrasound on the Samsung Medison R20 platform with the CA1-7S convex probe (DeepUSFF and shear-wave elastography), followed by non-contrast liver MRI including MRI-PDFF and MRE within ±7 days. Two intra-observer R20 measurement sessions are obtained in all participants; two-operator inter-observer measurements are obtained in 20 participants. Interplatform reproducibility substudy: 60 participants additionally undergo RS85 scanning on the same visit (two measurements per device) for paired R20-RS85 comparison. Receives: Device: Quantitative ultrasound (DeepUSFF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Ultrasound Fat Fraction and MRI-PDFF
earson correlation coefficient between quantitative ultrasound fat fraction (USFF) and MRI-PDFF
Measured: 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
Measured: At enrollment (single time point assessment)
Secondary outcomes (4)
AUC and optimal cut-off of DeepUSFF for MRI-PDFF-defined steatosis grades S1, S2, S3, computed independently per device platform
ROC comparison versus qualitative ultrasound assessment, per platform.
Measured: Assessed at the single study visit; ultrasound and MRI-PDFF are acquired within a ±7-day window
Intra-observer reproducibility of DeepUSFF reported per platform (RS85 and R20)
Intra-observer reproducibility of DeepUSFF (ultrasound-derived liver fat fraction) is assessed independently on each device platform (Samsung Medison RS85 and R20). For each participant in the respective device arm, a single operator acquires two independent DeepUSFF measurement sessions during the same study visit, with probe repositioning between sessions. Agreement between the two sessions is reported as the intraclass correlation coefficient (ICC, two-way random-effects, absolute agreement, single measurement; ICC(2,1)) with 95% confidence intervals, and as Bland-Altman analysis with mean bias and 95% limits of agreement. Results are reported separately for the RS85 arm (n=62) and the R20 arm (n=120).
Measured: At study visit (ultrasound and MRI-PDFF obtained within ±7 days)
Inter-observer reproducibility of DeepUSFF (per platform)
Inter-observer reproducibility of DeepUSFF (ultrasound-derived liver fat fraction), assessed independently on each device platform (Samsung Medison RS85 and R20) in a pre-specified subgroup of 20 participants per device arm. In each subgroup participant, two independent operators each acquire two DeepUSFF measurement sessions during the same study visit (probe repositioning between sessions). Agreement between operators is reported separately for each platform as the intraclass correlation coefficient (ICC, two-way random-effects, absolute agreement; ICC(2,1)) with 95% confidence intervals, and as Bland-Altman analysis with mean bias and 95% limits of agreement.
Measured: Day 1 (day of the study ultrasound examination)
R20-RS85 interplatform reproducibility of DeepUSFF
Interplatform reproducibility of DeepUSFF (ultrasound-derived liver fat fraction) between the Samsung Medison R20 and RS85 platforms, assessed within-subject in a pre-specified substudy of 60 participants from the R20 arm. Each substudy participant undergoes paired DeepUSFF examinations on both the R20 and RS85 platforms during the same study visit, with two independent measurement sessions acquired per device (probe repositioning between sessions). Agreement between platforms is reported as the intraclass correlation coefficient (ICC, two-way random-effects, absolute agreement; ICC(2,1)) with 95% confidence intervals, and as Bland-Altman analysis with mean bias and 95% limits of agreement. Pre-specified performance targets: ICC ≥ 0.90 and 95% limits of agreement within ±3% (absolute DeepUSFF units). MRI-PDFF obtained within ±7 days serves as the reference standard for the per-platform primary analysis but is not used in the interplatform comparison itself.
Measured: Day 1 (day of the paired R20 and RS85 ultrasound examinations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start24 Jun 2025
- Primary completion30 Apr 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern Ohio Radiology Research and Education Fund
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University HospitalRichard Gary Barr, MD, Study director, Northeastern Ohio Radiology Research and Education Fund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192159
- Sponsor's protocol ID
- 2503-162-1625
- Acronym
- DeepUSFF
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Requests should be directed to the corresponding author with a detailed research proposal. A data sharing agreement will be required, and institutional review board approval may be required for secondary analyses.