Validation Study of the Velacur System in Comparison to MRE & MRI-PDFF in Patients With (Suspected) Liver Disease

This will be a prospective, open label, validation study of the Velacur system in comparison to MRE and MRI-PDFF in patients with liver disease or suspected liver disease. Approximately 100 subjects may be enrolled in this study. Participants should span all levels of fibrosis and steatosis. The study is comprised of: Screening Period (up to 8 days) and Visit 1. There are no safety follow-up visits in this study. The primary objective of the study is to compare the results of Velacur against MRE and MRI-PDFF results for liver stiffness and steatosis. As part of prior studies, using MRE as the gold standard, clinical cut-off for Velacur have been developed. The primary objective of this study is to validate these cut-offs to see if Velacur can correctly classify patients. Secondary objectives include correlating the stiffness and attenuation results of Velacur with other clinical measures of fibrosis and steatosis such as Fib-4, and correlations with other clinical measurements collected through clinical care or clinical trials, such as Enhance Liver Fibrosis (ELF) test, FibroScan, MRI, or ultrasound based shear wave elastography (SWE) as they are available.