Each participant had a liver MRI examination at one of the 16 different clinical trial sites located in the United States of America or Japan, on either a 1.5T and 3T Siemen’s scanner (Siemens Healthineers, Erlangen, Germany) or a 1.5T GE scanner (GE Healthcare, Waukesha, WI). Each site had previously received full training and passed image quality assurance processes for the MRI data to be included in the trial.
MRI scanning was performed using Liver MultiScan image acquisition protocols [24 (link)–26 (link)]. For LMS-IDEAL PDFF measurements, four sets of transverse images of the liver were acquired at the level of the portal vein. Anonymised MRI data were processed and analysed centrally by expertly trained image analysts using Liver MultiScan. The processing included the calculation of LMS-IDEAL PDFF maps of the liver (measured in %) using proprietary algorithms based on the multispectral IDEAL approach, which is robust to MRI-related confounds [23 (link)]. Analysis included the calculation of LMS-IDEAL measures from the median value over three manually placed regions of interest in the right lobe of the liver, avoiding image artefacts and vessels (Fig 1).
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