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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Correlation between Samsung S-Viscosity and Canon Dispersion Slope
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •[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
排除标准
- •• 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
研究组 & 干预措施
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.
干预措施: Samsung Medison HERA W12 (R30) with S-Shearwave platform (Device)
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.
干预措施: Canon Aplio i800 with Dispersion Slope Imaging (Device)
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).
干预措施: Samsung Medison HERA W12 (R30) with S-Shearwave platform (Device)
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).
干预措施: Canon Aplio i800 with Dispersion Slope Imaging (Device)
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.
干预措施: Samsung Medison HERA W12 (R30) with S-Shearwave platform (Device)
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.
干预措施: Canon Aplio i800 with Dispersion Slope Imaging (Device)
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.
干预措施: Samsung Medison HERA W12 (R30) with S-Shearwave platform (Device)
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.
干预措施: Canon Aplio i800 with Dispersion Slope Imaging (Device)
结局指标
主要结局
Correlation between Samsung S-Viscosity and Canon Dispersion Slope
时间窗: At the time of single study visit (Day 0)
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.
Inter-vendor agreement (Bland-Altman analysis)
时间窗: At the time of single study visit (Day 0)
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
次要结局
- 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))
研究者
Jeong Min Lee
Professor
Seoul National University Hospital