Oxford, February 24th 2021 -- In a new study, Perspectum's LiverMultiScan® outperformed other markers of liver stiffness for identifying high risk NASH patients, encouraging its use as a non-invasive alternative to biopsy in clinical care and drug development.
Non-alcoholic fatty liver disease (NAFLD) affects up to 25% of the population worldwide. 20% of these cases progress to non-alcoholic steatohepatitis (NASH), a leading cause of liver transplant due to its strong propensity to develop into cirrhosis and hepatocellular carcinoma. Definitive diagnosis of these diseases requires liver biopsy, which has many limitations including pain, risks of complications, and high levels of inter-reading disagreement. This highlights the pressing need for alternative diagnostic tests for NASH.
In this study, emerging non-invasive imaging-based alternatives to liver biopsy were assessed and compared for the first time in a NASH cohort. The comparison included LiverMultiScan's MRI-based measures of fibro-inflammation (cT1) and fat (PDFF), magnetic resonance elastography (MRE), vibration-controlled transient elastography (VCTE-LSM, an ultrasound-based technique commonly referred to as FibroScan), 2D Shear-Wave elastography (SWE, another ultrasound-based technique) as well controlled attenuation parameter (VCTE-CAP, an ultrasound measure of fat). The different techniques were used to screen 144 patients who had liver biopsy for suspected NASH, and the diagnostic accuracies were compared.
The composite marker of LiverMultiScan's cT1 and PDFF outperformed all other techniques for identifying those with NASH as well as those with NASH and fibrosis. Furthermore, LiverMultiScan had fewer technical failures especially compared with ultrasound-based techniques, which were less reliable in patients with a higher body mass index.
Dr Kento Imajo, from the Department of Gastroenterology and Hepatology, Yokohama City University School of
Medicine, Japan and lead author on the study commented, "Although pathological diagnosis obtained by liver biopsy is the gold standard for the diagnosis of NASH, it is not only invasive, but also unreliable in determining the efficacy of treatment in some cases due to sampling error and intra/inter-observer variability in diagnosis by pathologists. In addition, the cost of repeated liver biopsies is prohibitive, so even in the NASH clinical trial, liver biopsies were performed only twice: before entry and at the end of the trial. This is where LiverMultiScan, a non-invasive diagnostic method, comes in. cT1 (corrected-T1) measurements obtained with LiverMultiScan can be used to assess overall NASH activity, especially liver inflammation and hepatocyte ballooning. The use of LiverMultiScan's cT1/PDFF and MR elastography has the potential to non-invasively diagnose most of the information obtained by liver biopsy, and if clinical outcomes can be easily assessed, patient acceptance may be facilitated."