Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI — Kids4LIFe  

Liver Diseases Clinical Trial

Official title: Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Fatty Liver
• Fibrosis
• Hepatitis
• Hepatitis, Autoimmune
• Inflammation
• Liver Cirrhoses
• Liver Cirrhosis
• Liver Diseases
• Liver Fibroses
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

• NCT number: NCT03198104
• Study type: Observational
• Source: Perspectum Diagnostics Ltd
• Status: Completed
• Start date: April 1, 2016
• Completion date: March 31, 2019