Non-alcoholic fatty liver disease (NAFLD) is the liver manifestation of the metabolic syndrome with global prevalence reaching epidemic levels. Despite the high disease burden in the population only a small proportion of those with NAFLD will develop progressive liver disease, for which there is currently no approved pharmacotherapy. Identifying those who are at risk of progressive NAFLD currently requires a liver biopsy which is problematic. Firstly, liver biopsy is invasive and therefore not appropriate for use in a condition like NAFLD that affects a large proportion of the population. Secondly, biopsy is limited by sampling and observer dependent variability which can lead to misclassification of disease severity. Non-invasive biomarkers are therefore needed to replace liver biopsy in the assessment of NAFLD. Our study addresses this unmet need. The LITMUS Imaging Study is a prospectively recruited multi-centre cohort study evaluating magnetic resonance imaging and elastography, and ultrasound elastography against liver histology as the reference standard. Imaging biomarkers and biopsy are acquired within a 100-day window. The study employs standardised processes for imaging data collection and analysis as well as a real time central monitoring and quality control process for all the data submitted for analysis. It is anticipated that the high-quality data generated from this study will underpin changes in clinical practice for the benefit of people with NAFLD. Study Registration: clinicaltrials.gov: NCT05479721

Pavlides, M., Mózes, F. E., Akhtar, S., Wonders, K., Cobbold, J., Tunnicliffe, E. M., Allison, M., Godfrey, E. M., Aithal, G. P., Francis, S., Romero-Gomez, M., Castell, J., Fernandez-Lizaranzu, I., Aller, R., González, R. S., Agustin, S., Pericàs, J. M., Boursier, J., Aube, C., Ratziu, V., Wagner, M., Petta, S., Antonucci, M., Bugianesi, E., Faletti, R., Miele, L., Geier, A., Schattenberg, J. M., Tilman, E., Ekstedt, M., Lundberg, P., Berzigotti, A., Huber, A. T., Papatheodoridis, G., Yki-Järvinen, H., Porthan, K., Schneider, M. J., Hockings, P., Shumbayawonda, E., Banerjee, R., Pepin, K., Kalutkiewicz, M., Ehman, R. L., Trylesinksi, A., Coxson, H. O., Martic, M., Yunis, C., Tuthill, T., Bossuyt, P. M., Anstee, Q. M., Neubauer, S., Harrison, S., Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study (the LITMUS imaging study): Study protocol, <<CONTEMPORARY CLINICAL TRIALS>>, 2023; 134 (Nov): N/A-N/A. [doi:10.1016/j.cct.2023.107352] [https://hdl.handle.net/10807/273470]

Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study (the LITMUS imaging study): Study protocol

Miele, Luca;
2023

Abstract

Non-alcoholic fatty liver disease (NAFLD) is the liver manifestation of the metabolic syndrome with global prevalence reaching epidemic levels. Despite the high disease burden in the population only a small proportion of those with NAFLD will develop progressive liver disease, for which there is currently no approved pharmacotherapy. Identifying those who are at risk of progressive NAFLD currently requires a liver biopsy which is problematic. Firstly, liver biopsy is invasive and therefore not appropriate for use in a condition like NAFLD that affects a large proportion of the population. Secondly, biopsy is limited by sampling and observer dependent variability which can lead to misclassification of disease severity. Non-invasive biomarkers are therefore needed to replace liver biopsy in the assessment of NAFLD. Our study addresses this unmet need. The LITMUS Imaging Study is a prospectively recruited multi-centre cohort study evaluating magnetic resonance imaging and elastography, and ultrasound elastography against liver histology as the reference standard. Imaging biomarkers and biopsy are acquired within a 100-day window. The study employs standardised processes for imaging data collection and analysis as well as a real time central monitoring and quality control process for all the data submitted for analysis. It is anticipated that the high-quality data generated from this study will underpin changes in clinical practice for the benefit of people with NAFLD. Study Registration: clinicaltrials.gov: NCT05479721
2023
Inglese
Pavlides, M., Mózes, F. E., Akhtar, S., Wonders, K., Cobbold, J., Tunnicliffe, E. M., Allison, M., Godfrey, E. M., Aithal, G. P., Francis, S., Romero-Gomez, M., Castell, J., Fernandez-Lizaranzu, I., Aller, R., González, R. S., Agustin, S., Pericàs, J. M., Boursier, J., Aube, C., Ratziu, V., Wagner, M., Petta, S., Antonucci, M., Bugianesi, E., Faletti, R., Miele, L., Geier, A., Schattenberg, J. M., Tilman, E., Ekstedt, M., Lundberg, P., Berzigotti, A., Huber, A. T., Papatheodoridis, G., Yki-Järvinen, H., Porthan, K., Schneider, M. J., Hockings, P., Shumbayawonda, E., Banerjee, R., Pepin, K., Kalutkiewicz, M., Ehman, R. L., Trylesinksi, A., Coxson, H. O., Martic, M., Yunis, C., Tuthill, T., Bossuyt, P. M., Anstee, Q. M., Neubauer, S., Harrison, S., Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study (the LITMUS imaging study): Study protocol, <<CONTEMPORARY CLINICAL TRIALS>>, 2023; 134 (Nov): N/A-N/A. [doi:10.1016/j.cct.2023.107352] [https://hdl.handle.net/10807/273470]
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