Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD (LYNX)

What this Trial Is About

Researchers are developing a new ultrasound-based method to measure the percentage of fat in the liver, focusing on people with metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD). This study aims to provide a non-invasive and more accessible alternative to current tests like MRI or biopsy, which can be costly or invasive. The goal is to support early detection and monitoring of liver health, especially in individuals with obesity, diabetes, high blood pressure, or high cholesterol. The study uses advanced ultrasound devices including the Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan, and Philips 3T Ingenia Elition MRI system to capture detailed imaging and radiofrequency data. Participants include healthy adults and those diagnosed or suspected of having MASLD or meeting high-risk cardiometabolic criteria. The research collects various ultrasound parameters and MRI data to develop and train a new quantifiable ultrasound biomarker. Participants will undergo multiple imaging tests and clinical evaluations to gather necessary data for the study. The main outcome is comparing the new ultrasound biomarker to the MRI proton density fat fraction over one year. Secondary measures include comparing individual ultrasound parameters and shear wave elastography with MRI techniques. The study involves healthy volunteers and patients, with follow-up visits during the year to monitor and assess liver fat and stiffness. The total participation duration aligns with the one-year outcome measurement period.

Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis