Diffusion-weighted Imaging Magnetic Resonance for Assessing Liver Fibrosis
Condition: Fibrosis, Liver
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Several noninvasive radiological techniques have been investigated for the diagnosis of liver
      fibrosis and cirrhosis among patients with chronic infection with hepatitis B virus or
      hepatitis C virus. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a particularly
      appealing method for the diagnosis of liver fibrosis. The aims of this study are to evaluate
      the accuracy of DW-MRI in patients with chronic viral hepatitis for determining the stage of
      liver fibrosis.
    

Detailed description: 
      Among patients with chronic infection with hepatitis B virus or hepatitis C virus, evaluation
      of the stage of liver fibrosis is of major importance for determining prognosis and
      therapeutic decisions. Liver biopsy is a costly and invasive technique with associated
      mortality and morbidity. A typical biopsy fragment represents only 1/50,000 of the organ.
      Several noninvasive radiological techniques have been investigated for the diagnosis of liver
      fibrosis and cirrhosis. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a
      particularly appealing method for the diagnosis of liver fibrosis. Because it is easy to
      implement, non-operator dependent, and process without the need for contrast agents. However,
      preliminary studies on small numbers of patients in which various hardware and sequencing
      profiles were used have reported inconsistent results for staging liver fibrosis with DW-MRI.
      The aims of this study are to evaluate correlation between stage of hepatic fibrosis and
      liver apparent diffusion coefficient (ADC) and normalized liver ADC with spleen assessed by
      DW-MRI in patients with chronic viral hepatitis B or C. Also, this study aim to evaluate
      factors that influence liver ADC and normalized liver ADC with spleen value for predicting
      the stage of liver fibrosis as well as to estimate the optimal cutoff values of DW-MRI for
      determining significant liver fibrosis (fibrosis stage ≥2) and advanced fibrosis (fibrosis
      stage ≥3).
    

Intervention name(s): Diffusion-weighted magnetic resonance imaging (DW-MRI)
Intervention type(s): Device
Intervention description(s): Magnetic resonance (MR) imaging examination of liver will be performed on a 3.0T Achieva MR scanner (Philips Medical Systems, The Netherlands). Diffusion-weighted imaging (DWI) will be performed using a single-shot echo-planar imaging during a single end expiratory breath-hold. A single observer placed circular regions of interest around 2.30 cm2 to measure mean signal intensity (SI) in the right hepatic lobe and the spleen for each b value, avoiding areas of artifact, vessels, and focal lesions. A monoexponential fit will be performed to calculate liver and spleen apparent diffusion coefficient (ADC) on the basis of ln(SI) as a function of b value, using all b values. Normalized liver ADC will be calculated as the ratio of liver ADC to spleen ADC.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hepatitis B; Hepatitis C; Fibrosis, Liver; Magnetic Resonance Imaging