LiverMultiScan Clinical Primer

Introduction

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LiverMultiScan is a non-invasive MRI based procedure for liver disease. It is an FDA-cleared and CE-marked precision medicine solution that provides standardised and validated quantitative metrics to provide a comprehensive assessment of liver health.

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The metrics included are:

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• cT1 - A unique measure of disease activity that further predict liver and cardiovascular outcomes.¹
• Liver Fat Content - Derived from Proton Density Fat Fraction (PDFF) providing an accurate and consistent measure percentage measure enabling accurate classification of steatosis levels.
• Liver Iron Content - A precise measure of the of iron present within the liver, reported as mg of iron / g of dry weight correlated to a clinically meaningful cut off point.

How is cT1 generated?

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CT1 is a proprietary measure provided only via Perspectum. Inflammation and fibrosis cause an increase in the extracellular water volume which is detected by changes in MRI T1 measurements.² cT1 corrects the T1 measure for iron providing a measurement that is highly accurate, repeatable and reproducible.³  

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cT1 is unaffected by body habitus, ensuring consistent results across diverse patient profiles and remaining sensitive to dynamic changes in disease activity. A change of 80ms in cT1 has been consistently demonstrated to be clinically meaningful and correlates with histological changes.⁴ This positions LiverMultiScan as a precision tool for monitoring treatment response and guiding treatment decisions.⁵

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Multiple publications evidence its use as a high-performing biomarker for use in the management of chronic liver diseases including MASLD and MASH, autoimmune hepatitis⁶, viral hepatitis⁷ and less common conditions including Wilson’s disease and Fontan’s patients.

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LiverMultiScan - Clinical Utility

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MASLD & MASH

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Metabolic dysfunction-associated steatotic liver disease is defined as steatotic liver disease in the presence of one or more cardiometabolic risk factors.  The spectrum of MASLD ranges from simple steatosis to metabolic dysfunction-associated steatotohepatitis (MASH), fibrosis, cirrhosis and MASH-related hepatocellular carcinoma (HCC).

It has a global prevalence of > 30% and this is rapidly increasing.

EASL and AASLD guidelines recommend the use of noninvasive tests, including LiverMultiScan, in individuals who are at risk of MASLD, including those with cardiometabolic risk factors, abnormal liver enzymes and radiological signs of hepatic steatosis, particularly in patients with type 2 diabetes and obesity. ⁸

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For ease of reference the following table is provided

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• cT1 less than 800 ms & PDFF less than 5% = Low risk of MASLD
• cT1 between 800 - 875ms & PDFF between 5 - 10% = MASH
• cT1 greater than 875 ms & PDFF greater than 10% = At risk MASH with Fibrosis 

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Autoimmune hepatitis

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LiverMultiScan has further utility as an adjunct biomarker to monitor patients with autoimmune hepatitis over time and to assist treatment withdrawal decisions, by aiding risk-stratification without the use of percutaneous liver biopsy.

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A state-of-the-art clinical review noted that multiparametric MRI imaging as used in LiverMultiScan could serve as a virtual biopsy as it provides a panoramic view of liver tissue characteristics, which supports assessment of the heterogenous distribution of disease across the liver. ⁹

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cT1 has been shown to predict relapse in patients with autoimmune hepatitis even when their blood tests and other imaging tests have been normal.⁶  

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Hepatitis C

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cT1 is recognised as more sensitive than traditional liver enzymes such as AST or ALT in determining a patient’s response to antiviral treatment.⁷ Ongoing research is looking to establish further evidence in support of cT1 and its use in viral hepatitis B as well as establishing the appropriate levels to influence clinical outcomes.

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References

1. Roca-Fernandez A, Banerjee R, Thomaides-Brears H, etal. Liver disease is a significant risk factor for cardiovascular outcomes - AUK Biobank study. J Hepatol 2023;79(5):1085-1095. DOI:10.1016/j.jhep.2023.05.046.
2. Banerjee R, Pavlides M, Tunnicliffe EM, et al.Multiparametric magnetic resonance for the non-invasive diagnosis of liverdisease. J Hepatol 2014;60(1):69-77. DOI: 10.1016/j.jhep.2013.09.002.
3. Andersson A, Kelly M, Imajo K, et al. Clinical Utilityof Magnetic Resonance Imaging Biomarkers for Identifying NonalcoholicSteatohepatitis Patients at High Risk of Progression: A Multicenter Pooled Dataand Meta-Analysis. Clin Gastroenterol Hepatol 2022;20(11):2451-2461 e3. DOI:10.1016/j.cgh.2021.09.041.
4. Noureddin M BC, Loomba R, Harisinghani M, Harrison S,Alkhouri N. Decreases in liver cT1 accurately reflect histological improvementinduced by therapies in NASH with enhanced sensitivity to fibrosis change: amulti-centre pooled cohort analysis EASL, London, 22 June 2022–26 June.
5. Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, et al.AASLD Practice Guidance on the clinical assessment and management ofnonalcoholic fatty liver disease. Hepatology 2023;77(5):1797-1835. DOI:10.1097/HEP.0000000000000323.
6. Arndtz K, Shumbayawonda E, Hodson J, et al.Multiparametric Magnetic Resonance Imaging, Autoimmune Hepatitis, andPrediction of Disease Activity. Hepatol Commun 2021;5(6):1009-1020. DOI:10.1002/hep4.1687.
7. Jayaswal ANA, Levick C, Collier J, et al. Liver cT(1)decreases following direct-acting antiviral therapy in patients with chronichepatitis C virus. Abdom Radiol (NY) 2021;46(5):1947-1957. DOI:10.1007/s00261-020-02860-5.
8. European Association for the Study of the Liver .Electronic address eee, European Association for the Study of D, EuropeanAssociation for the Study of O, European Association for the Study of the L.EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolicdysfunction-associated steatotic liver disease (MASLD). J Hepatol 2024. DOI:10.1016/j.jhep.2024.04.031.
9. Muratori L, Lohse AW, Lenzi M. Diagnosisand management of autoimmune hepatitis. BMJ 2023;380:e070201. DOI:10.1136/bmj-2022-070201