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

NCT07530419 | Not Yet Recruiting DMC

• 2 other identifiers: SNUH-RAD-SWE-Visco-2026-V1.2SNUH IRB: 2601-153-1712
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease; Fatty Liver; Liver Fibrosis

Keywords

Shear wave elastography; Viscoelasticity; Dispersion slope; Liver stiffness; Quantitative ultrasound; MASLD; MASH; S-Viscosity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Normal reference range of viscoelasticity parameters

  At the time of single study visit (Day 0)

• Inter-cohort comparison of viscoelasticity parameters

  At the time of single study visit (Day 0)

• Modified US-FAST score performance (exploratory)

  At the time of single study visit (Day 0)

• Reproducibility of viscoelasticity measurements

  At the time of single study visit (Day 0)

• Technical success rate

  At the time of single study visit (Day 0)

Study Arms (4)

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; Device: Canon Aplio i800 with Dispersion Slope Imaging

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; Device: Canon Aplio i800 with Dispersion Slope Imaging

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; Device: Canon Aplio i800 with Dispersion Slope Imaging

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; Device: Canon Aplio i800 with Dispersion Slope Imaging

Interventions

Canon Aplio i800 with Dispersion Slope Imaging DEVICE

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 A: Healthy Reference (Living-donor candidates); Cohort B: Low MASH Risk MASLD (Rule-out); Cohort C: At-Risk MASH MASLD (Rule-in); Cohort D: Indeterminate Zone (Exploratory subgroup)

Samsung Medison HERA W12 (R30) with S-Shearwave platform DEVICE

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 %).

Cohort A: Healthy Reference (Living-donor candidates); Cohort B: Low MASH Risk MASLD (Rule-out); Cohort C: At-Risk MASH MASLD (Rule-in); Cohort D: Indeterminate Zone (Exploratory subgroup)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \[Cohort A - Healthy reference\]
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Fatty Liver; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jeong Min Lee, MD, PhD

CONTACT

+82-2-2072-3154; jmlshy2000@gmail.com

Jeong Hwan Park, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

KR (1)