Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH (POCUS-NASH)

August 22, 2022 updated by: E-Scopics

Evaluation of Diagnostic Performances of a New Point-of-care Ultrasound System for the Detection of Fibrotic NASH and the Assessment of Liver Disease Severity in Patients With Known or Suspected Chronic Liver Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any of the following criteria:

    • Patients with known chronic liver diseases referred to liver-specific exams by their referring physician as part of the routine practice, including a VCTE exam, with or without a blood test, a MRI/MRE exam, a liver biopsy,
    • Patients screened for fibrotic NASH in the context of NASH pharmaceutical trials, for which a data sharing agreement has been signed between E-Scopics and the pharmaceutical trial promoter,
  • Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation,
  • European patients covered by a social security program

Exclusion Criteria:

  • Patients under 18 years of age or over 80 years of age,
  • Patients with active implants such as pacemakers, defibrillators, pumps, etc.
  • Patients presenting wounds at the location where the ES1 probe shall be placed on patients' skin,
  • Adult patients under social tutorship, or unable to provide informed consent when not subject to tutorship measures,
  • Pregnant and breastfeeding women,
  • People deprived of their freedom rights
  • People who have been hospitalized without giving informed consent or under emergency situation,
  • People admitted in a social or sanitary institution for other reasons than the Clinical Investigation,
  • Patients included in another research study that could interfere with the present Clinical Investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main arm
Main study arm
Device: Ultrasound liver assessment
The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
Other Names:
  • Elastography
  • Ultrasound attenuation
  • Sound speed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elastography diagnostic performance
Time Frame: At study completion, 1 year
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.
At study completion, 1 year
Diagnostic performance estimates
Time Frame: At study completion, 1 year

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
At study completion, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver stiffness robustness indicators
Time Frame: At study completion, 1 year
  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
At study completion, 1 year
Equivalence with other methods
Time Frame: At study completion, 1 year
  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
At study completion, 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory outcome 1: Liver steatosis
Time Frame: At study completion, 1 year
  1. R² correlation coefficient and p-value between ES1 ultrasound attenuation measurements and MRI PDFF
  2. Concordance Correlation Coefficients (CCC) and 95% confidence intervals, and Bland-Altman graphs between ultrasound attenuation measurements and MRI PDFF
  3. R² correlation coefficient and p-value between ES1 speed of sound measurements and MRI PDFF
  4. Concordance Correlation Coefficients (CCC) and 95% confidence intervals, and Bland-Altman graphs between speed of sound measurements and MRI PDFF
At study completion, 1 year
Exploratory outcome 2: Intra-hepatic inflammation and/or hepatocytes ballooning
Time Frame: At study completion, 1 year
  1. Correlation coefficients between ES1 parameters or combinations of parameters and histological scoring for lobular inflammation (A0 to A3) and/or ballooning.
  2. If relevant, area under the ROC curve for combinations of ES1 parameters or combinations of parameters used as a diagnostic measures of liver inflammation severity using histological scoring for lobular inflammation (A0 to A3)
  3. If relevant for given binary diagnostic objectives (detect ≥ A1, ≥ A2, or A3), calculate optimal diagnostic cutoffs and estimate diagnostic performances
At study completion, 1 year
Exploratory outcome 3: Liver NAS Score
Time Frame: At study completion, 1 year
  1. Correlation coefficients between ES1 parameters or combinations of parameters and histological NAS score (NAS 0 to NAS 8).
  2. If relevant, area under the ROC curve for combinations of ES1 parameters or combinations of parameters used as a diagnostic measure of NAFLD-related activity using the histological NAS score (0 to 8)
  3. If relevant, for given binary diagnostic objectives (detect < NAS 3, ≥ NAS 3, ≥ NAS 5), calculate optimal diagnostic cutoffs and estimate diagnostic performances
At study completion, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

E-Scopics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

November 3, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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