The Effect of Multi-Parametric Magnetic Resonance Imaging in Standard of Care for Nonalcoholic Fatty Liver Disease: Protocol for a Randomized Control Trial (Preprint)

Abstract

UNSTRUCTURED The rising prevalence of non-alcoholic fatty liver disease (NAFLD) and the more aggressive subtype, non-alcoholic steatohepatitis (NASH), is a global public health concern. Left untreated, NAFLD/NASH can lead to cirrhosis, liver failure and death. The current standard for diagnosing and staging liver disease is a liver biopsy which is costly, invasive, and carries risk for the patient. Therefore, there is a growing need for a reliable, feasible, and cost-effective non-invasive diagnostic tool for these conditions. LiverMultiScan is one such tool and uses multiparametric MRI (mpMRI) to characterise liver tissue and to aid in the diagnosis and monitoring of liver diseases of various aetiologies. RADIcAL1 is a multi-centre randomised control trial to investigate the use of mpMRI as a standardised diagnostic test for liver disease. Patients in the control arm will be treated as per centre guidelines. Patients in the study arm will be treated according to the result of the mpMRI, so that further diagnostic evaluation is recommended only when values for metrics of liver fat or fibro-inflammation are elevated. The primary objective of this study is evaluation of the cost-effectiveness of the use of mpMRI in the tertiary-referral hepatology centres making up this trial (three in European countries and 10 in the UK). The primary outcome for this trial is to evaluate the utility of mpMRI in reducing the burden of patients with suspected fatty liver disease that incur unnecessary additional liver-related hospital consultations and/or liver biopsies. The trial may therefore highlight the health economic burden on tertiary-referral hepatology clinics imposed by unnecessary clinical consultations and invasive investigations.