Liver disease is a rapidly developing epidemic that poses a huge medical and socio-economic burden on the society. Chronic liver diseases are called ‘silent killers’, as clinical symptoms only surface at late stages of the disease, when it is not treatable. Non-alcoholic fatty liver disease (NAFLD), a condition defined by fat accumulation in the liver, and its sub-type non-alcoholic steatohepatitis (NASH) are the major forms of liver disease. Untreated NAFLD/NASH can lead to cirrhosis and to liver failure.
At present, the only way of diagnosing and staging liver disease is with liver biopsy, which is costly, invasive and hence uncomfortable, and carries some risk. Thus, clinicians are reluctant to use it for people suspected of having NAFLD/NASH. In addition, invasive biopsy is not optimal for serial assessment (e.g. monitoring transplant population for signs of liver rejection).
LiverMultiScan™ is a novel imaging software application that use multiparametric magnetic resonance imaging (MR) to characterises the liver tissue to aid the diagnosis of liver disorders. LiverMultiScan™ was introduced in Europe and the United States as a research device in 2014. It is now installed in leading medical institutions on five continents. Used in the clinical management of patients with chronic liver disease, the technology offers a quantitative liver assessment in a safe, non-invasive 15-minute MRI scan. Analysis is based on assessment of native properties of liver tissue, accurate measurement of liver fat and other metrics. The technology is currently being used to assess primary endpoints in clinical trials for investigational therapies to treat NAFLD and NASH.
LiverMultiScan™ product and features may not be commercially available in all countries. For further details of labelling, claims, clinical data and publications, visit Perspectum Diagnostics.
1. To validate the cost-effectiveness and added value of LiverMultiScan™ compared to the standard care pathway for assessing chronic liver disease
RADIcAL1: Non-invasive rapid assessment of non-alcoholic fatty liver disease (NAFLD) using Magnetic Resonance Imaging with LiverMultiScan™.
Over the next two years, 2,000 patients suspected of a diagnosis of fatty liver disease will be recruited for the RADIcAL1 study from the University Hospital clinics in Ulm (Germany), Leiden (The Netherlands) and Coimbra (Portugal). Health Economic Research Centre (HERC), Oxford, will perform the health economic analysis to investigate whether the introduction of LiverMultiScan™ as a diagnostic test for liver disease can prove a cost-effective method in one or more different EU territories.
Please see here the flow chart illustrating the participant’s journey in RADIcAL1 study
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2. To demonstrate the sensitivity and specificity of LiverMultiScan™ as a medical support tool for stratifying patients that have high risk of liver transplant rejection
RADIcAL2: Non-Invasive rapid assessment of patients with liver transplants using magnetic Resonance Imaging with LiverMultiScan™.
RADIcAL2 study will investigate the use of LiverMultiScan™ on 50 paediatric patients at Kings College Hospital, London, and 150 adult patients from University Hospital clinics in Ulm (Germany), Leiden (The Netherlands) and Coimbra (Portugal). The aim of this study will be to establish whether the burden of liver biopsy can be reduced during monitoring of post-transplant patients.
Please see here the flow chart illustrating the participant’s journey in RADIcAL2 study
click here to close
3. Share and disseminate evidence of benefits of LiverMultiScan™ as a novel non-invasive, radiation-free, one-step solution that provides fast detection of liver disease at early stage, providing accurate diagnosis for all types of patients (including obese people and those with high iron levels in the liver), and capable of assessing the entire liver volume.