Perspectum’s RADIcAL1 trial - addressing the health economic burden of invasive diagnostics for NAFLD and NASH
Oxford December 9th, 2020. The growing need for cost-effective non-invasive tools to diagnose fatty liver disease and reduce the number of painful, costly and risky liver biopsies is being addressed by Perspectum’s RADIcAL1 trial, as outlined in the recently published research protocol.
The prevalence of non-alcoholic fatty liver disease (NAFLD) and the more aggressive subtype, non-alcoholic steatohepatitis (NASH) is increasing, fuelled by the rise in obesity and type 2 diabetes. The current standard for diagnosing and staging liver disease is a liver biopsy which is costly, invasive, and carries risk for the patient. A potential non-invasive alternative could be Perspectum’s LiverMultiScan®, which uses multiparametric MRI (mpMRI) to characterise liver tissue by measuring the amount of fat (PDFF), iron (T2*) and fibro-inflammation (cT1). These measures can aid the diagnosis and monitoring of liver diseases, and recently have been shown to accurately predict clinical outcomes [Jayaswal et al, 2020].
Read more about NAFLD/NASH here.
RADIcAL1 trial
The trial compares the use of LiverMultiScan for diagnosing fatty liver disease with the current standard of care, evaluating cost-effectiveness in terms of the numbers of patients requiring additional liver-related hospital consultations and/or liver biopsies for the two different care pathways.
A total of up to 1072 adult patients with suspected fatty liver disease are included in the trial at 10 different sites, from across Germany, Netherlands, Portugal and the United Kingdom.
If effective the trial may highlight the health economic burden imposed by unnecessary consultations and invasive diagnostic investigations, as well as demonstrate that including LiverMultiScan as a NAFLD diagnostic test may be cost-effective compared to liver-related hospital consultations and/or liver biopsies.
The trial will provide the evidence to accelerate decision making regarding the inclusion of mpMRI-based tools such as LiverMultiScan in existing NAFLD/NASH clinical care.
Dr. Minneke Coenraad from Leiden University Medical Centre and one of the investigators leading the study explained that, “A cost-effective tool for non-invasive liver tissue characterisation would be a major step forward in the treatment of patients with liver diseases such as non-alcoholic fatty liver disease.”
RADIcAL is a clinical research project which utilises Perspectum’s non-invasive quantitative LiverMultiScan technology to optimise the diagnosis and care pathways for patients with liver disease. This project has received funding from the European Union’s Horizon 2020 SME Instrument Phase 2 Program under grant agreement No 719445.