Magnetic Resonance Imaging in the Evaluation of Liver Fibrosis
Condition: Liver Fibrosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      The main purpose of this pilot study is to evaluate non-invasive magnetic resonance imaging
      (MRI) techniques in the detection and grading of liver fibrosis, so that the investigators
      can reduce the need of invasive techniques such as liver biopsy and transjugular hepatic
      venous portal pressure gradient (HVPG) measurements to assess the degree of liver scarring
      and portal hypertension.
    

Detailed description: 
      In chronic liver diseases of all aetiology, persistent hepatocyte injury leads to progressive
      fibrosis and cirrhosis. In the UK, 76 adults per 100,000 population have cirrhosis and its
      incidence is increasing (Fleming et al., J Hepatol 2008,49,p732-738). Currently, liver biopsy
      is the only method of assessing the degree of fibrosis. However, liver biopsy is associated
      with limitations such as sampling error, intra- and inter-observer variations in
      interpretation and adverse events (Morbidity 1-5% and mortality between 1 in 1,000 to 1 in
      10,000), hence considered a 'Silver (rather than Gold) standard'. Assessment of degree of
      fibrosis is necessary to stage the disease process, determine the timing of intervention and
      for prognosis.

      Development of portal hypertension as a result of progressive fibrosis is a landmark in the
      natural history of chronic liver diseases as it accounts for majority of complications and
      clinical outcome. The degree of fibrosis and presence of portal hypertension will determine
      whether patients are included in surveillance programmes for the early detection of varices
      and hepatocellular carcinoma. As with assessment of the degree of fibrosis, the presence and
      degree of portal hypertension can only be determined by transjugular hepatic venous portal
      pressure gradient (HVPG) measurements, another investigation that is also hampered by access,
      costs, risks and difficulty of serial measurements.

      A variety of evolving techniques using magnetic resonance imaging (MRI) (Talwalkar et al.,
      Hepatology 2008; 47:332-42) if validated and established, have potential to replace liver
      biopsy and HVPG measurements. The non-invasive nature of MRI, its ability to estimate amount
      of accumulated fat (1H MR spectroscopy), cell membrane turnover (31P-MRS), iron
      (relaxometry), fibrosis (MR elastography) as well as an ability to assess portal blood flow
      and hepatic perfusion (Arterial Spin Labelling (ASL)) make it an ideal tool to evaluate liver
      structure and function and to stage the liver disease. Most recently, MRI has seen
      unprecedented developments in terms of accuracy of quantitation and speed of assessment,
      which has been realised due to data-sharing ultra-fast MRI sequences, multispectral analysis,
      and refinement of elastography methods. Validation of evolving MRI techniques against liver
      biopsies, HVPG and metabolomics is a critical step prior to its translation into clinical
      applications by the creation of MRI biomarkers.
    

Intervention name(s): Blood sample; MRI Scan
Intervention type(s): Procedure; Other
Intervention description(s): 1 fasted blood sample taken for metabolomics; 1 single visit for MRI and MRS
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: MRI; liver biopsy; serological markers