Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound
Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound
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.
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.
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.