Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI
Condition: Non-alcoholic Steatohepatitis; Liver Diseases; Liver Fibroses; Autoimmune Hepatitis; Liver Cirrhoses
MeSH terms: Hepatitis; Liver Diseases; Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hepatitis, Autoimmune; Fibrosis; Inflammation
Study type: Observational

Summary: 
      This is a prospective observational study which will recruit up to 100 paediatric
      participants over a period of 30 months to determine whether MRI is as accurate at detecting,
      distinguishing, and monitoring liver disease as current standard of care techniques such as
      liver biopsy and fibroscan.
    

Detailed description: 
      The most serious pandemic facing Europe is fatty liver disease and non-alcoholic
      steatohepatitis (NASH). The main causal factor is obesity: according to recent statistics
      11.8m-16.3m European children are overweight, of which 2.9m - 4.4m are obese. Unfortunately,
      current techniques for the diagnosis and monitoring of liver disease in children are poor.
      Available methods are either insensitive, such as blood tests, or invasive, i.e. liver
      biopsy, which is risky, painful, and costly. Although it is currently considered to be the
      gold standard for tissue assessment, liver biopsy has severe limitations, one of which is
      that it samples only a tiny fraction of the liver, and so it cannot give a representative
      diagnosis when liver disease is regional. Early determination of liver diseases in children,
      could have a significant impact on changing the course of illness and on the proper treatment
      management.

      Perspectum Diagnostics have demonstrated that multiparametric MR imaging can, for the first
      time, allow accurate, non-invasive detection of liver fibrosis/inflammation in adults, and
      predict clinical outcomes (1,2). However, liver disease in children differs from adults in
      aetiology, natural history and pathological findings (3,4).

      This study will investigate whether non-invasive multiparametric MR imaging of the liver can
      accurately and reproducibly detect, distinguish and track progression of different forms of
      liver disease in the paediatric population. To achieve this, children with liver disease who
      are scheduled to undergo liver biopsy and blood tests as part of their standard care will be
      recruited. Non-invasive, pain-free MRI scanning will be used to measure fibrosis, iron
      content and fat content of liver tissue and compare these results to the findings of the
      liver biopsy that is being performed as standard care. Children who are scheduled to receive
      repeated liver biopsies to monitor their response to the treatment of autoimmune hepatitis as
      part of their usual care will also be included. Repeated MRI scans will be performed and
      compared with the results of biopsy findings.
    

Intervention name(s): MRI
Intervention type(s): Device
Other intervention name(s): LiverMultiScan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants aged between 6-18 years of age with liver disease who are scheduled to receive
        a liver biopsy as part of their usual care and age-matched healthy volunteers aged 6-18
        years of age. Participants between 1-10 years of age who are scheduled to receive an MRI
        scan under anesthesia as part of their standard care will also be recruited.
      
Biospecimen description: 
      Liver biopsy and histology.
    
Keywords: Multiparametric MR Imaging; Paediatric