Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD) (SAVID-SLD)

Prospective Evaluation of Samsung Medison 2D Shear Wave Elastography Viscoelasticity Parameters in Patients With Steatotic Liver Disease Using Canon Dispersion Slope Imaging as Reference Standard: A Single-Center Non-Interventional Observational Study

Steatotic liver disease (SLD) is one of the most common chronic liver diseases worldwide. Distinguishing simple steatosis from metabolic dysfunction-associated steatohepatitis (MASH) with significant fibrosis is clinically important, but liver biopsy - the current standard - is invasive. Recent ultrasound technology allows noninvasive measurement of tissue viscoelasticity, which has been linked to liver inflammation. Samsung Medison's HERA W12 system (S-Viscosity) and Canon Aplio i800 (Dispersion Slope Imaging) both provide vendor-specific viscoelasticity parameters derived from shear-wave dispersion analysis, but their relationship and agreement have not been compared in SLD patients.

This prospective single-center observational study will enroll approximately 95-100 participants in three cohorts: (A) 15-20 living-donor candidates as a healthy reference, (B+C) approximately 80 adults with sonographically suspected or confirmed SLD recruited consecutively. SLD participants will be classified post-hoc into low-MASH-risk (Cohort B) and at-risk MASH (Cohort C) subgroups using a multi-parametric stratification combining liver stiffness (LSM), DeepUSFF (deep-learning-based ultrasound fat fraction), and serum AST. All participants will undergo same-day ultrasound examination with both Samsung HERA W12 and Canon Aplio i800. The primary objective is to evaluate the correlation and agreement between Samsung S-Viscosity and Canon Dispersion Slope. Secondary objectives include deriving a normal reference range from the healthy cohort, comparing viscoelasticity parameters across cohorts, and exploring a Modified US-FAST score.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatty Liver; Liver Fibrosis; Metabolic Dysfunction-Associated Steatotic Liver Disease
• Intervention / Treatment: Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform; Device: Canon Aplio i800 with Dispersion Slope Imaging

Detailed Description

Background: Two-dimensional shear wave elastography (2D SWE) is widely used to quantify liver stiffness for fibrosis assessment, but stiffness can be confounded by inflammation, congestion, and other factors. Frequency-dependent shear-wave dispersion analysis yields viscosity-related parameters that may reflect tissue inflammation. Canon's Dispersion Slope Imaging (DS, [m/s]/kHz) has been validated against histology in the multicenter iLEAD study (Sugimoto et al., Radiology 2024) and shown to correlate with lobular inflammation in MASLD. Samsung Medison has recently introduced S-Viscosity within the S-Shearwave platform of the HERA W12 R30 system, providing dispersion-derived viscosity parameters from a single SWE acquisition; however, head-to-head comparison with Canon DS in SLD patients has not been reported.

Hypothesis: Samsung S-Viscosity and Canon Dispersion Slope, both derived from frequency-dependent shear-wave analysis, will demonstrate moderate-to-strong correlation and clinically acceptable inter-vendor agreement in patients with steatotic liver disease.

Study Design: Single-center, prospective, non-interventional observational study. Adult participants (≥18 years) will be enrolled into three cohorts: Cohort A (Healthy reference, n=15-20): living-donor candidates with confirmed steatosis <5%, normal LFTs, and exclusion of chronic liver disease, recruited during routine donor evaluation. Cohort B+C (SLD, n≈80): adults with sonographically suspected or confirmed hepatic steatosis scheduled for clinical abdominal ultrasound, recruited consecutively. Post-hoc stratification of SLD participants uses LSM (2D S-SWE), DeepUSFF, and serum AST with institutionally-validated cutoffs (LSM 6.82 kPa for ≥F2 fibrosis; DeepUSFF asymmetric cutoffs of 7.86% for <S1 rule-out and 15.05% for ≥S2 rule-in; AST 40 U/L institutional ULN) to define Low MASH risk (Cohort B), At-risk MASH (Cohort C), and an Indeterminate zone.

Procedures: All participants undergo same-day ultrasound examinations on both Samsung HERA W12 (CA 1-7S probe) and Canon Aplio i800 (i8C1 probe) in randomized order, with operators blinded to LFT results at the time of scanning. From the right hepatic lobe via right intercostal approach after a minimum 4-hour fast: Samsung acquisitions include 2D S-Viscosity, 2D S-SWE, TAI, and DeepUSFF (5 measurements per parameter, 2 sessions); Canon acquisitions include Dispersion Slope Imaging and 2D SWE (5 measurements). Median values are used as representative.

Statistical Analysis: Primary endpoints - Pearson or Spearman correlation between Samsung S-Viscosity and Canon Dispersion Slope (with 95% CI), and Bland-Altman analysis of inter-vendor agreement (mean bias and 95% limits of agreement). Sample size of approximately 80 SLD participants provides adequate precision for both correlation (r=0.4 to 0.6) and Bland-Altman limits-of-agreement estimation (±0.5 SD precision). Secondary endpoints include 95% reference interval derivation from Cohort A (n≥15 for nonparametric estimation), inter-cohort comparisons, Modified US-FAST score exploration, reproducibility (ICC and CV%), and technical success rate.

• Study Type: Observational
• Enrollment (Estimated): 95

Contacts and Locations

• Study Contact: Name: Jeong Min Lee, MD, PhD; Phone Number: +82-2-2072-3154; Email: jmlshy2000@gmail.com
• Study Contact Backup: Name: Jeong Hwan Park, MD

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older recruited from Seoul National University Hospital, including (1) living-donor candidates undergoing donor evaluation as a healthy reference cohort, and (2) outpatients with sonographically suspected or confirmed hepatic steatosis scheduled for clinical abdominal ultrasound.

Description

Inclusion Criteria:

• [Cohort A - Healthy reference]

  • Adults ≥18 years old
  • Currently undergoing living-donor evaluation at SNUH
  • Donor evaluation confirms (a) hepatic steatosis <5% by imaging or biopsy, (b) normal AST/ALT, and (c) absence of chronic liver disease (HBV, HCV, autoimmune, cholestatic, etc.)
  • Provided written informed consent [Cohort B + C - Steatotic liver disease]
  • Adults ≥18 years old
  • Sonographically suspected or confirmed hepatic steatosis on B-mode ultrasound, scheduled for clinical abdominal ultrasound
  • Serum AST/ALT results available within 6 weeks of ultrasound, or scheduled
  • Provided written informed consent

Exclusion Criteria:

• • Significant alcohol intake within the past 2 years (>30-60 g/day for males, >20-50 g/day for females)

  • Diagnosed or strongly suspected chronic liver disease (active HBV/HCV, autoimmune liver disease, cholestatic liver disease, Wilson's disease, hemochromatosis, etc.)
  • Suspected hepatic failure or decompensated cirrhosis (albumin <3.2 g/dL, INR >1.3, direct bilirubin >1.3 mg/dL)
  • Ascites, history of variceal bleeding, or acute biliary obstruction rendering stable measurements unfeasible
  • History of liver malignancy or treatment for liver malignancy
  • History of liver surgery
  • Pregnancy or lactation
  • Inadequate ultrasound image quality due to obesity, bowel gas, or patient inability to cooperate

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A: Healthy Reference (Living-donor candidates); Adult living-donor candidates undergoing donor evaluation at SNUH. Confirmed hepatic steatosis <5%, normal AST/ALT, and absence of chronic liver disease. Participation does not affect donor candidacy decisions.	Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform; Two-dimensional shear-wave elastography acquisition with the Samsung HERA W12 R30 system using the CA 1-7S convex probe. Five valid measurements per parameter are obtained from the right hepatic lobe via right intercostal approach, repeated in 2 sessions. Output parameters include S-Viscosity (dispersion-derived viscosity index), 2D S-SWE (liver stiffness in kPa), TAI (tissue attenuation imaging), and DeepUSFF (deep-learning-based ultrasound fat fraction in %).; Device: Canon Aplio i800 with Dispersion Slope Imaging; Two-dimensional shear-wave elastography and Dispersion Slope Imaging acquisition with the Canon Aplio i800 system using the i8C1 convex probe. Five valid measurements are obtained from the right hepatic lobe via right intercostal approach. Output parameters include 2D SWE (liver stiffness in kPa) and Dispersion Slope (in [m/s]/kHz, viscosity-related).
Cohort B: Low MASH Risk MASLD (Rule-out); Adults with sonographically suspected or confirmed hepatic steatosis classified post-hoc as low MASH risk by satisfying ALL three criteria: LSM <6.82 kPa AND DeepUSFF <7.86% (<S1) AND AST ≤40 U/L (institutional ULN).	Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform; Two-dimensional shear-wave elastography acquisition with the Samsung HERA W12 R30 system using the CA 1-7S convex probe. Five valid measurements per parameter are obtained from the right hepatic lobe via right intercostal approach, repeated in 2 sessions. Output parameters include S-Viscosity (dispersion-derived viscosity index), 2D S-SWE (liver stiffness in kPa), TAI (tissue attenuation imaging), and DeepUSFF (deep-learning-based ultrasound fat fraction in %).; Device: Canon Aplio i800 with Dispersion Slope Imaging; Two-dimensional shear-wave elastography and Dispersion Slope Imaging acquisition with the Canon Aplio i800 system using the i8C1 convex probe. Five valid measurements are obtained from the right hepatic lobe via right intercostal approach. Output parameters include 2D SWE (liver stiffness in kPa) and Dispersion Slope (in [m/s]/kHz, viscosity-related).
Cohort C: At-Risk MASH MASLD (Rule-in); Adults with sonographically suspected or confirmed hepatic steatosis classified post-hoc as at-risk MASH by satisfying mandatory LSM ≥6.82 kPa (suggestive of ≥F2 significant fibrosis) AND at least one of: DeepUSFF ≥15.05% (≥S2) OR AST >40 U/L. Participants meeting neither Cohort B nor Cohort C definitions are classified as 'Indeterminate' and analyzed as an exploratory subgroup.	Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform; Two-dimensional shear-wave elastography acquisition with the Samsung HERA W12 R30 system using the CA 1-7S convex probe. Five valid measurements per parameter are obtained from the right hepatic lobe via right intercostal approach, repeated in 2 sessions. Output parameters include S-Viscosity (dispersion-derived viscosity index), 2D S-SWE (liver stiffness in kPa), TAI (tissue attenuation imaging), and DeepUSFF (deep-learning-based ultrasound fat fraction in %).; Device: Canon Aplio i800 with Dispersion Slope Imaging; Two-dimensional shear-wave elastography and Dispersion Slope Imaging acquisition with the Canon Aplio i800 system using the i8C1 convex probe. Five valid measurements are obtained from the right hepatic lobe via right intercostal approach. Output parameters include 2D SWE (liver stiffness in kPa) and Dispersion Slope (in [m/s]/kHz, viscosity-related).
Cohort D: Indeterminate Zone (Exploratory subgroup); Adults with sonographically suspected or confirmed hepatic steatosis who do not meet the full criteria for either Cohort B (Low MASH risk) or Cohort C (At-risk MASH). This cohort primarily includes participants with DeepUSFF values in the S1 range (7.86% to <15.05%), or those meeting only a subset of the Cohort B/C criteria. Cohort D is analyzed as a pre-specified exploratory subgroup and is not included in the primary stratified comparison between Cohort B and Cohort C. Descriptive statistics are reported separately.	Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform; Two-dimensional shear-wave elastography acquisition with the Samsung HERA W12 R30 system using the CA 1-7S convex probe. Five valid measurements per parameter are obtained from the right hepatic lobe via right intercostal approach, repeated in 2 sessions. Output parameters include S-Viscosity (dispersion-derived viscosity index), 2D S-SWE (liver stiffness in kPa), TAI (tissue attenuation imaging), and DeepUSFF (deep-learning-based ultrasound fat fraction in %).; Device: Canon Aplio i800 with Dispersion Slope Imaging; Two-dimensional shear-wave elastography and Dispersion Slope Imaging acquisition with the Canon Aplio i800 system using the i8C1 convex probe. Five valid measurements are obtained from the right hepatic lobe via right intercostal approach. Output parameters include 2D SWE (liver stiffness in kPa) and Dispersion Slope (in [m/s]/kHz, viscosity-related).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Samsung S-Viscosity and Canon Dispersion Slope	Pearson or Spearman correlation coefficient (with 95% CI) between Samsung S-Viscosity and Canon Dispersion Slope, calculated from the median of 5 valid measurements per device per participant.	At the time of single study visit (Day 0)
Inter-vendor agreement (Bland-Altman analysis)	Mean bias and 95% limits of agreement between Samsung S-Viscosity and Canon Dispersion Slope calculated by Bland-Altman analysis. As the two parameters use different units, agreement will also be assessed after z-score transformation	At the time of single study visit (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal reference range of viscoelasticity parameters	95% reference interval (2.5-97.5 percentile) of Samsung S-Viscosity and Canon Dispersion Slope estimated nonparametrically from Cohort A (healthy reference cohort).	At the time of single study visit (Day 0)
Inter-cohort comparison of viscoelasticity parameters	Difference in Samsung S-Viscosity and Canon Dispersion Slope between Cohort B (Low MASH risk) and Cohort C (At-risk MASH), tested by t-test or Mann-Whitney U.	At the time of single study visit (Day 0)
Modified US-FAST score performance (exploratory)	AUROC of a Modified US-FAST score - calculated by substituting Samsung 2D S-SWE LSM and DeepUSFF into the LSM and CAP positions of the original FAST score formula (Newsome et al., Lancet Gastroenterol Hepatol 2020) - for identifying Cohort C participants. Correlation with Canon Dispersion Slope is also assessed.	At the time of single study visit (Day 0)
Reproducibility of viscoelasticity measurements	Intraclass correlation coefficient (ICC, 2-way random effects) and coefficient of variation (CV%) of repeated viscoelasticity measurements across two acquisition sessions per device.	At the time of single study visit (Day 0)
Technical success rate	Proportion of participants in whom valid viscoelasticity measurements were successfully obtained on both devices (Samsung HERA W12 and Canon Aplio i800).	At the time of single study visit (Day 0)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Sugimoto K, et al. US Markers and Necroinflammation, Steatosis, and Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease: The iLEAD Study. Radiology. 2024;312(2):e233377. Newsome PN, et al. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020;5(4):362-373. Barr RG, et al. Update to the Society of Radiologists in Ultrasound Liver Elastography Consensus Statement. Radiology. 2020;296(2):263-274. WFUMB Guidelines/Guidance on Liver Multiparametric Ultrasound. Ultrasound Med Biol. 2024;50(8):1088-1098.

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Liver stiffness; Quantitative ultrasound; Shear wave elastography; Viscoelasticity; MASLD; MASH; Dispersion slope; S-Viscosity
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Cirrhosis
• Other Study ID Numbers: SNUH-RAD-SWE-Visco-2026-V1.2; SNUH IRB: 2601-153-1712 (Other Identifier: Seoul National University Hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No