Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound (ELF)

September 19, 2018 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Comparison of Magnetic Resonance and Ultrasound Elastography With Liver Biopsy for Noninvasive Staging of Liver Fibrosis

Liver fibrosis is an important public health problem, with a substantial morbidity and mortality due to progression to cirrhosis and hepatocellular carcinoma. All causes of chronic liver disease may lead to fibrosis. The traditional diagnostic approach requires a biopsy for assessing the severity of liver disease prior to therapy.

However, liver biopsy has several limitations: cost, sampling error, and procedure-related morbidity and mortality. Considering the high prevalence of viral hepatitis and nonalcoholic fatty liver disease, a condition often associated with obesity and type 2 diabetes, there is an urgent need for noninvasive screening, diagnosis and monitoring strategies of chronic liver disease severity.

Our team has the expertise to investigate ultrasound-based and magnetic resonance-based elastographic methods for the noninvasive staging of liver fibrosis.

The primary objective of this cross-sectional study is to compare the sensitivity of elastographic methods for detecting histology-determined significant fibrosis.

The secondary objectives are to compare the diagnostic accuracy of these elastographic methods and the influence of potential confounders (inflammation, steatosis and iron deposition) on their diagnostic accuracy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Liver fibrosis is an important public health problem, with a substantial morbidity and mortality due to cirrhosis (the end stage) and hepatocellular carcinoma. All causes of chronic liver disease may lead to fibrosis. The amount of fibrosis determines the prognosis and influences the response to treatment of chronic liver disease.

Several elastographic methods have been proposed for noninvasive detection and staging of liver fibrosis. Transient elastography (Fibroscan) is widely used by clinicians. Acoustic radiation force impulse (ARFI) is an elastography technique recently integrated in clinical ultrasound systems that may provide similar diagnostic performance to transient elastography. Magnetic resonance elastography (MRE) is a new method that can be integrated to a liver MRI study, which would allow liver stiffness, steatosis, iron overload and inflammation quantification in chronic liver disease.

Objectives: 1) To compare the sensitivity of MRE and ARFI for detecting histology-determined significant fibrosis (F ≥ 2). Secondary objectives: 2) To compare the diagnostic accuracy of MRE, ARFI and Fibroscan for predicting histology-determined fibrosis stages. 3) To determine the influence of inflammation, steatosis, and iron deposition on the diagnostic accuracy of MRE, ARFI and Fibroscan for predicting fibrosis. 4) To determine thresholds optimizing sensitivity of ARFI and Fibroscan to screen patients and optimizing specificity of MRE to confirm liver fibrosis stage.

Design: This will be a cross-sectional imaging trial comparing feasibility, diagnostic and fibrosis staging accuracy of stiffness measurements by elastographic methods in 108 patients with chronic liver disease, using histopathology as the reference standard. Paired index tests (MRE, ARFI and Fibroscan) will be performed as research procedures in close temporal proximity to the reference test (liver biopsy).

Inclusion criteria: consecutive adult patients with known or suspected chronic liver disease secondary to hepatitis B virus, hepatitis C virus, or nonalcoholic fatty liver disease (NAFLD) undergoing a liver biopsy for clinical indications.

Exclusion criteria: any contraindication to MRI, refusal to participate or provide informed consent, pregnant women, any other cause of chronic liver disease than hepatitis B, hepatitis C or NAFLD.

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population is adults with any of the three main causes of liver fibrosis: HBV, HCV or NASH. For the purpose of this study, we will recruit patients seen at the hepatology clinic of St-Luc Hospital, a tertiary care center.

Description

Inclusion Criteria:

  • are adults;
  • must undergo a liver biopsy as part of their clinical standard of care for suspected or known chronic liver disease caused by HBV, HCV or NASH;
  • understand French or English instruction;
  • Autoimmune Hepatitis

Exclusion Criteria:

  • have any contra-indication to MRI (such as claustrophobia, pacemaker, metallic clips for a neurosurgical procedure);
  • are pregnant or trying to become pregnant;
  • have a weight or girth preventing them from entering the MR magnet bore;
  • are unable to understand or unwilling to provide written informed consent for this study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatis C, Hepatitis B, NAFLD

All patients enrolled will undergo:

  • Transient Elastography (Fibroscan)
  • Acoustic Radiation Force Impulse (ARFI)
  • Magnetic Resonance Elastography (MRE)
Device: Transient elastography, acoustic radiation force impulse, magnetic resonance elastography
Transient elastography (Fibroscan) Acoustic Radiation Force Impulse (ARFI) Magnetic Resonance Elastography (MRE)
Other Names:
  • Transient elastography (Fibroscan)
  • Acoustic Radiation Force Impulse (ARFI)
  • Magnetic Resonance Elastography (MRE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histology-determined fibrosis stage
Time Frame: Within 6 weeks of elastographic methods
Within 6 weeks of elastographic methods

Secondary Outcome Measures

Outcome Measure
Time Frame
Magnetic Resonance Imaging (MRI)-based Proton Density Fat Fraction (PDFF)
Time Frame: Within 6 weeks of liver biopsy
Within 6 weeks of liver biopsy
Fibroscan-determined liver stiffness
Time Frame: Within 6 weeks of liver biopsy
Within 6 weeks of liver biopsy
Acoustic Radiation Force Impulse (ARFI)-determined liver stiffness
Time Frame: Within 6 weeks of liver biopsy
Within 6 weeks of liver biopsy
Magnetic Resonance Elastography (MRE)-determined liver stiffness
Time Frame: Within 6 weeks of liver biopsy
Within 6 weeks of liver biopsy
Magnetic Resonance Imaging (MRI) cine-tagging of cardiac-induced motion for staging liver fibrosis
Time Frame: Within 6 weeks of liver biopsy
Within 6 weeks of liver biopsy

Collaborators and Investigators

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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Canadian Institutes of Health Research (CIHR)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE12.062

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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