LiverMultiscan by PERSPECTUM



LiverMultiScan in NASH Clinical Trials

LiverMultiscan® provides quantitative biomarkers of hepatic fibro-inflammation and fat fraction, using iron-corrected T1 (cT1) and proton density fat fraction (MRI-PDFF) respectively. T1, an MR sequence, 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).

 

Both cT1 and MRI-PDFF have been shown to correlate with histological results of fibrosis, inflammation and steatosis1,2,3,4,5, and cT1 has additionally been shown to predict liver-related outcomes2

 

LiverMultiScan is currently being utilized in Phase 1, 2 and 3 NASH clinical trials to both screen for eligible patients and monitor their response to treatment. cT1 as well as MRI-PDFF are additionally under evaluation in the FDA Biomarker Qualification Program as diagnostic enrichment biomarkers for the identification of NASH patients with likely histopathological results of NAS≥4 F≥2, which is the target cohort for therapy.

The histological features that contribute to steatohepatitis, including fibrosis and inflammation, can be characterized by measuring cT11,2,3 Clinical studies have shown that cT1 helps effectively stratify patient populations and enrich for NASH with F2/3 fibrosis6.

 

 

The American College of Radiology Appropriate Use Criteria for chronic liver disease states that MRI is more accurate than ultrasound for the evaluation of cirrhosis in obese patients and patients with NAFLD.

 

cT1 values reported by LiverMultiScan are standardized across field strengths and major MRI manufacturers6. Technical performance and validation studies have demonstrated that both cT1 and PDFF, packaged into LiverMultiScan, provide a scalable solution that can be measured independent of MRI vendor, have low test-retest variability, and high cross-scanner reproducibility.7



 This is key for collecting robust data in multi-center clinical trials. Both cT1 and MRI-PDFF have excellent reproducibility and repeatability7, allowing smaller and more cost-effective trials to be run with confidence and increased likelihood of detecting efficacy.

For this reason, cT1 can be effectively used to facilitate multi-site trial enrollment, support accurate detection of early treatment efficacy and enable longitudinal monitoring of patient health more safely and effectively than by serial biopsy.

 

 

References

1.Banerjee, R., et al. (2014). Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. Journal of Hepatology, 60(1), 69-77.  doi: 10.1016/j.jhep.2013.09.002.

2. Pavlides, M., et al. (2016). Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease. Journal of Hepatology, 64(2), 308-315. doi: 10.1016/j.jhep.2015.10.009.

3. Pavlides, M., et al. (2017). Multiparametric magnetic resonance imaging for the assessment of non-alcoholic fatty liver disease severity. Liver International, 37(7), 1065-1073. doi: 10.1111/liv.13284.

4. Idilman IS et al. Hepatic steatosis: quantification by proton density fat fraction with MR imaging versus liver biopsy. Radiology. 2013;267:767–75. doi: 10.1148/radiol.13121360.

5. Caussy C, Reeder SB, et al. Noninvasive, Quantitative Assessment of Liver Fat by MRI-PDFF as an Endpoint in NASH Trials. Hepatology 2018;68:763-72. doi: 10.1002/hep.29797 

6. Wilman, H.R., et al. (2017). Characterisation of liver fat in the UK Biobank cohort. PLOS ONE, 12(2), e0172921. doi: 10.1371/journal.pone.0172921

7. Bachtiar V et al. (2019) Repeatability and reproducibility of multiparametric magnetic resonance imaging of the liver. PLoS ONE 14(4): e0214921. doi: 10.1371/journal.pone.0214921

 






 

Notice that the informations presented here were provided by PERSPECTUM and are not redacted by NASHBIOTECHS



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