JMIR Publications

ABSTRACT

Background:

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 promising tool that uses multiparametric MRI (mpMRI) to characterise liver tissue and to aid in the diagnosis and monitoring of liver diseases of various aetiologies.

Objective:

The primary objective of this trial (RADIcAL1) is to evaluate the cost-effectiveness of the use of mpMRI in tertiary-referral hepatology centres as a standardised diagnostic test for NAFLD.

Methods:

RADIcAL1 is a multi-centre randomised control trial with two arms conducted in four European territories (13 sites, from across Germany, Netherlands, Portugal and the United Kingdom). In total, 1072 adult patients with suspected fatty liver disease will be randomised to 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. Patients in the control arm will be treated as per centre guidelines for standard of care. 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. Secondary outcomes include patient feedback from a patient satisfaction questionnaire, at baseline and all follow-up visits to the end of the study, and time from randomisation to diagnosis by the physician, as recorded at final follow-up visit.

Results:

This trial is currently open for recruitment. The anticipated completion date for the study is December 2020.

Conclusions:

This randomized controlled trial will provide the evidence to accelerate decision making regarding the inclusion of mpMRI-based tools in existing NAFLD/NASH clinical care. RADIcAL1 is among the first and largest European health economic studies of imaging technologies for fatty liver disease. Strengths of the trial include the high-quality research design and in-depth assessment of the implementation of the cost-effectiveness of the mpMRI diagnostic. If effective the trial may therefore highlight the health economic burden on tertiary-referral hepatology clinics imposed by unnecessary consultations and invasive diagnostic investigations and demonstrate that including LiverMultiScan as a NAFLD diagnostic test may be cost-effective compared to liver-related hospital consultations and/or liver biopsies. Clinical Trial: ClinicalTrials.gov NCT03289897 https://clinicaltrials.gov/ct2/show/NCT03289897