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

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ClinicalTrials.gov Identifier: NCT02044523
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : September 20, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

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.


Condition or disease Intervention/treatment
Hepatitis C Hepatitis B Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Steatohepatitis (NASH) Device: Transient elastography, acoustic radiation force impulse, magnetic resonance elastography

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.


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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparison of Magnetic Resonance and Ultrasound Elastography With Liver Biopsy for Noninvasive Staging of Liver Fibrosis
Study Start Date : January 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018


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)




Primary Outcome Measures :
  1. Histology-determined fibrosis stage [ Time Frame: Within 6 weeks of elastographic methods ]

Secondary Outcome Measures :
  1. Fibroscan-determined liver stiffness [ Time Frame: Within 6 weeks of liver biopsy ]
  2. Acoustic Radiation Force Impulse (ARFI)-determined liver stiffness [ Time Frame: Within 6 weeks of liver biopsy ]
  3. Magnetic Resonance Elastography (MRE)-determined liver stiffness [ Time Frame: Within 6 weeks of liver biopsy ]
  4. Magnetic Resonance Imaging (MRI)-based Proton Density Fat Fraction (PDFF) [ Time Frame: Within 6 weeks of liver biopsy ]
  5. Magnetic Resonance Imaging (MRI) cine-tagging of cardiac-induced motion for staging liver fibrosis [ Time Frame: Within 6 weeks of liver biopsy ]

Biospecimen Retention:   Samples Without DNA
Liver biopsy specimens.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044523


Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0A9
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Canadian Institutes of Health Research (CIHR)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
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Principal Investigator: An Tang, MD, MSc Centre hospitalier de l'Université de Montréal (CHUM)

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02044523     History of Changes
Other Study ID Numbers: CE12.062
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: July 2017

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Chronic liver disease
Fibrosis
Elastography
Ultrasound
Magnetic resonance elastography
Diagnostic performance
Sensitivity and specificity

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Hepatitis
Hepatitis A
Hepatitis C
Fibrosis
Hepatitis B
Liver Diseases
Liver Cirrhosis
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections