The main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with NASH, and to compare them to other non-invasive tests.
This is a prospective cross-sectional study that will recruit approximately 1000 patients across 30 clinical sites in Europe and the USA. The target recruited population will include adult patients at risk of, or with known chronic liver diseases, whether or not screened for inclusion in NASH pharmaceutical trials. After being informed about the study objectives and potential risks, patients who consent to participate will undergo an non-invasive external ultrasound exam of their liver using an ultraportable diagnostic ultrasound system. The system will derive quantitative information related to physical and acoustic properties of the liver tissue, which are known to correlate with the severity of chronic diffuse liver diseases such as fibrosis and steatosis. The study will also assess the repeatability, reproducibility and robustness of quantitative parameters. Collected data will also enable exploring ultrasound-based liver tissue characterization correlated to NASH-specific histological lesions such as intra-hepatic inflammation and hepatic cell ballooning.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
Elastography diagnostic performance
Differences between areas under ROC curves for the ES1 liver stiffness measurement, used as a diagnostic measure of liver fibrosis severity, and other methods, in NASH patients.
Time frame: At study completion, 1 year
Diagnostic performance estimates
Estimates of diagnostic performances at a defined cutoff, for binary diagnostic objectives (detect ≥ F2, ≥ F3, or F4): 1. Sensitivity, specificity, and diagnostic accuracy 2. Positive and negative predictive values
Time frame: At study completion, 1 year
Liver stiffness robustness indicators
1. Dispersion and standard deviation of measurements 2. Intra-class Correlation Coefficients (ICC) and 95% confidence intervals for intra-operator repeatability 3. Intra-class Correlation Coefficients (ICC) and 95% confidence intervals for inter-operator reproducibility 4. Intra-subject variance 5. Intra-operator variance 6. Standard error on measurements
Time frame: At study completion, 1 year
Equivalence with other methods
1. R² correlation coefficient and p-value between ES1 and VCTE liver stiffness measurements 2. R² correlation coefficient and p-value between ES1 and MRE liver stiffness measurements 3. Average of quadratic errors between 2 equipment 4. Concordance Correlation Coefficients (CCC) and 95% confidence intervals
Time frame: At study completion, 1 year
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