Large Population Imaging Study Reveals Utility of LiverMultiScan's Corrected T1 Measure as Potential Biomarker for Liver Health in Metabolic Diseases

OXFORD, England, July 31, 2018 /PRNewswire/ --

• Potential for new quantitative biomarker for assessment of liver health; cT1
• Only 37% of the UK BioBank population studied were classified as low risk for NAFL
• Highlights necessity of iron correction for assessment of T1

An MRI-based measure, corrected T1 (cT1), could be used as a potential biomarker for liver health, a study in collaboration with Massachusetts General Hospital, Perspectum Diagnostics and the University of Westminster has found.

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This study involved over 2,800 subjects from the UK BioBank MRI imaging study. The UK BioBank is the world's largest study of its kind ever undertaken. The paper has revealed a tight distribution of cT1 values in a sub-population at low risk for non-alcoholic fatty liver disease. In comparison, the cT1 values were significantly elevated in 'higher-risk' sub-populations.

With the burgeoning obesity epidemic, the prevalence of both Non-Alcoholic Fatty Liver Disease (NAFLD), the build-up of fat in the liver, and Non-Alcoholic Steatohepatitis (NASH) inflammation in the liver, are rapidly increasing. Liver disease, including NAFLD and NASH, is usually asymptomatic until the development of cirrhosis, therefore it is critical to identify individuals who are risk and enable early diagnosis. In order to establish which populations are at risk, normality and abnormality need to be ascertained in the context of NAFL and NASH.

Of the population studied, only 37% of participants were classified as being at 'low risk' of NAFLD, i.e. those with a BMI under 25kg/m2and liver fat under 5%. Perspectum Diagnostics' proprietary technology, LiverMultiScan™ was used to calculate the patients' cT1 values. In separate research studies this novel imaging biomarker has been shown to correlate with histology and to predict prognosis (Banerjee, 2014; Pavlides, 2016). The results in this paper showed a tight distribution in the low-risk group, which can act as a baseline comparator in the diagnosis of patients with suspected NAFLD and NASH. The excellent intra-rater and inter-rater reproducibility observed in this study for cT1 provides further support for its utility. Separate research (Pavlides, 2017) has shown that cT1 can distinguish between NAFL and NASH, increasing its utility and adding value to a fat content measure alone to assess fatty liver disease.

Professor Stefan Neubauer, Chief Medical Officer at Perspectum Diagnostics, commented that, "Currently patients with suspected liver disease are biopsied which can cause great pain and distress, and there is a big need for a non-invasive biomarker to enable better care of patients. This study establishes a tight normal range for cT1 in a large low-risk population, an important pre-requisite for an imaging biomarker that can an aid early diagnosis and, hopefully, will reduce the number of patients who are unnecessarily biopsied."

LiverMultiScan corrects for the amount of iron in the liver, as high iron levels can distort the magnetic field and obscure the readings. In this population 36.5% of subjects had sufficiently high iron concentration in their livers to necessitate correction, emphasizing the importance of this method. Iron correction was also needed in cases of mild iron overload that in itself does not pose a clinical problem.

This paper includes an appendix of interesting case studies taken from the Patient Understanding of LiverMultiScan trial and from Massachusetts General Hospital, these case studies show the use of LiverMultiScan and cT1 across a variety of diseases. Dr Amirkasra Mojtahed from the Division of Abdominal Imaging at Massachusetts General Hospital, Boston stated that, "As we move into the era of personalized medicine, it is increasingly becoming important to develop quantitative imaging biomarkers that are uniform across various vendor platforms. This study is an important step in the path for developing a standardized imaging biomarker for liver health and has the potential to replace some of the inherently subjective current methods of assessing liver health."

This manuscript adds to the growing literature on T1 mapping in the liver and displays, for the first time, the reference range of cT1 values in a large population at low risk for NAFL, therefore demonstrating its potential as a biomarker for future studies.

References  

Banerjee et al. 2014, Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease, Journal of Hepatology, Volume 60 , Issue 1 , 69 - 77

Pavlides et al. 2016, Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease, Journal of Hepatology , Volume 64 , Issue 2 , 308 - 315

Pavlides, et al. 2017, Multiparametric magnetic resonance imaging for the assessment of non-alcoholic fatty liver disease severity Liver International, 37(7), pp.1065-1073.

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SOURCE Perspectum Diagnostics