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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 %).
• Устройство 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).

Первичные конечные точки

• Correlation between Samsung S-Viscosity and Canon Dispersion Slope [Срок оценки: At the time of single study visit (Day 0)]
• Inter-vendor agreement (Bland-Altman analysis) [Срок оценки: At the time of single study visit (Day 0)]

Вторичные конечные точки (5)

• Normal reference range of viscoelasticity parameters [Срок оценки: At the time of single study visit (Day 0)]
• Inter-cohort comparison of viscoelasticity parameters [Срок оценки: At the time of single study visit (Day 0)]
• Modified US-FAST score performance (exploratory) [Срок оценки: At the time of single study visit (Day 0)]
• Reproducibility of viscoelasticity measurements [Срок оценки: At the time of single study visit (Day 0)]
• Technical success rate [Срок оценки: At the time of single study visit (Day 0)]

Критерии участия

Критерии включения

• \[Cohort A - Healthy reference\]

• 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Публикации

• 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 validati

Идентификаторы

NCT: NCT07530419 · SNUH-RAD-SWE-Visco-2026-V1.2 · SNUH IRB: 2601-153-1712

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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