Challenges of liver disease clinical trials
Liver biopsy is currently the only definitive diagnostic for staging and monitoring liver disease. This presents challenges for clinical trial design, including recruitment of patients and selection of appropriate outcome measures to determine therapeutic efficacy. Differentiating patients who will progress to clinically-relevant liver disease is a further challenge. For every ten patients biopsied, only one may meet the entry criteria. These factors can make clinical trials in this area time-consuming and costly.
How we can accelerate your clinical development
LiverMultiScan™ Discover provides unparalleled liver image analysis services that support clinical trials in a variety of ways, providing enhanced imaging Quantitative Analysis Service to characterize liver tissue non-invasively. Our imaging biomarkers provide correlates of the measurements of liver fat, hepatic iron content, inflammation and fibrosis, which are suitable for monitoring treatment effects during interventional trials, and can help you to see signals of success more quickly.
Using LiverMultiScan Discover to stratify patients can reduce the number of ineligible patients who go forward for liver biopsy, saving them from the risk and inconvenience of an unnecessary biopsy, and reducing the time and cost of recruitment.
We are currently providing technology solutions and consulting in clinical trials across a range of liver disorders, and have significant experience in NAFLD/NASH therapeutic development.Contact us
Biomarkers - see what we measure
We provide assessment of the following biomarkers at our central reading facility:
- Iron (T2*)
- Fat (MRI-PDFF)
- Inflammation and fibrosis (cT1)
For more information on each metric read below.
Iron overload is quantified using a T2* map, which is one of the MR relaxation parameters. Its value is heavily influenced by disturbances in the local magnetic field, such as those caused by the presence of iron. T2* is used as a biomarker in the assessment of hepatic iron overload, or hemosiderosis and to obtain the corrected T1 measure.
Liver fat is quantified using state-of-the-art proton density fat fraction (PDFF) calculations, which exploit the chemical-shift in water and fat separation to estimate hepatic fat concentration. PDFF is an MR-based biomarker that can be readily standardized across MR platforms, scanners and field strengths to provide a reproducible and robust measure of liver fat.
Inflammation and fibrosis (cT1)
cT1 (another important MR relaxation parameter) has been used as a biomarker for the assessment of myocardial inflammation and fibrosis and is an emerging technique for rapid quantification of hepatic fibro-inflammatory disease. T1 is affected by how tightly bound the water protons are and is essentially a surrogate measure of free water in the tissue. Free water, and therefore T1, increases with fibrosis and inflammation. However, T1 is also affected by the presence of iron and this effect must be corrected for (corrected T1, or cT1). cT1 is scanner-, field strength- and vendor-independent, allowing standardization of this measurement across different MRI systems and sites.
LiverMultiScan Discover - the bespoke pharma service
LiverMultiScan™ Discover is Perspectum Diagnostics research software platform with enhanced analysis capabilities that enables post-processing of Magnetic Resonance Imaging (MRI) data into parametric maps. This includes segmentation analysis to enable the assessment across a whole liver slice, offering global statistics and insight into tissue heterogeneity.
Unlike ultrasound or MR-based elastography techniques, which attempt to provide an indication of hepatic fibrosis by measuring the mechanical properties of liver “stiffness”. LiverMultiScan Discover uses MRI mapping techniques to characterize liver tissue at the cellular level, delivering quantification of liver fat, iron load and pro-inflammatory disease using Proton Density Fat Fraction (PDFF), T2* and T1 maps.
LiverMultiScan Discover is unique in that it corrects for the interdependencies of these MR signals. In patients with increased hepatic iron, alternative MR assessments, such as MR elastography, suffer due to low signal, which can result in inadequate visualization of shear waves. Similarly, without considering the effect of iron, measurements of T1 are inaccurate (leading to misclassification) in a substantial proportion of patients. To learn more about the science behind multiparametric MRI read our publications.
A 57 year-old NAFLD patient who made lifestyle changes in response to seeing their LiverMultiScan report.
LiverMultiScan was carried out at two time points and shows a change in metrics of liver health as a result of lifestyle interventions.
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