Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.

The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI PDFF. The primary objective is to compare ultrasound parameters measurements of ultrasound attenuation, backscattering coefficient and sound speed to the hepatic fat fraction as measured with MRI-PDFF. The secondary objectives includes the comparison of measurements of quantitative ultrasound parameters between Hepatoscope and FibroScan, and to compare the measurement of liver stiffness between Hepatoscope and MRE. Exploratory objectives have been determined to allow the comparison of said measured parameters to the outcome of histopathological analysis in a subset patient population who would benefit from a liver biopsy.