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), defined by fat accumulation in the liver, is the most prevalent chronic liver disease and, along with its fibroinflammatory sub-type non-alcoholic steatohepatitis (NASH), can lead to cirrhosis and liver failure. This rapidly developing epidemic and associated co-morbidities pose a huge medical and socio-economic burden on society in Europe. In Germany, France, Italy and the UK the annual cost of NAFLD is approximately €35 billion, equating to €354 to €1,163 per patient (Younossi et al, 2016). Furthermore, annual healthcare costs related to liver disease are 86% higher in those with advanced liver disease than without and require additional procedures. For example, liver transplant surgery costs are estimated at €55,677 per patient annually (Petta et al, 2019). Thus, treating NAFLD/NASH patients at an early stage, when the disease is still curable, could benefit these patients and society as a whole.
At present, the gold standard for diagnosing and staging liver disease is liver biopsy, which is costly, invasive, and carries risk for the patient. For these reasons, clinicians are reluctant to use it for people suspected of having NAFLD/NASH or for serial assessment for disease monitoring. Perspectum Ltd has developed LiverMultiScan®, a novel, non-invasive, quantitative Magnetic Resonance Imaging (MRI) post-processing software tool that has demonstrated high diagnostic accuracy for the early assessment of liver disease (Banerjee et al, 2014; Pavlides et al, 2016; Pavlides et al, 2017). This technology has the potential to improve the care pathway for patients with suspected NAFLD, by reducing the number of visits and unnecessary liver biopsies. Perspectum was awarded a Horizon 2020 grant by the European Commission, Executive Agency for Small and Medium-sized Enterprises (EASME) to develop the health economic case for LiverMultiScan as part of the diagnostic pathway in European healthcare settings. This project is known as RADIcAL.
RADIcAL comprises two clinical studies RADIcAL1 (R1) and RADIcAL2 (R2).
The specific objectives are:
•To validate the cost-effectiveness and added value of LiverMultiScan compared to the standard care pathway for assessing chronic liver disease
•To demonstrate the sensitivity and specificity of LiverMultiScan as a medical support tool for stratifying patients that have high risk of liver transplant rejection
•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.
Following the emergence of COVID-19 in 2020, Perspectum launched a new study, COVERSCAN, with the aim to assess the recovery of patients who had contracted the SARS-CoV-2 Virus in the UK. This study is based on the CoverScan Medical Device (MD), which has recently received exceptional use authorisation from the Medicines and Healthcare products Regulatory Agency in the UK and is an extension of LiverMultiScan which can assess multiple visceral organs in addition to the liver. The aim of the COVERSCAN study was to determine the prevalence and degree of organ damage in patients recovering from COVID-19 disease using multi-parametric MRI to assess the lungs, heart, liver, kidneys, pancreas and spleen over a follow up period of 6 months, post infection.
