Accuracy of Imaging Techniques Including Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Steatohepatitis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease Comparison With the Histological Reference Standard

What this Trial Is About

Non-alcoholic fatty liver disease (NAFLD) is a common condition that can progress to a more serious form called non-alcoholic steatohepatitis (NASH), which may lead to liver fibrosis, cirrhosis, liver failure, and cancer. This research aims to evaluate how accurately non-invasive imaging methods like ultrasound and magnetic resonance can diagnose NASH and fibrosis in patients with or at high risk of NAFLD, using liver biopsy as the comparison standard. The study is important because liver biopsy, while accurate, has drawbacks such as being invasive and having risks, so better non-invasive tools are needed as new treatments are being developed. Participants who need a liver biopsy to assess NAFLD will undergo both liver ultrasound and a detailed magnetic resonance imaging exam. The ultrasound includes shear wave elastography to measure liver stiffness and a fatty liver indicator, while the MRI uses multiple techniques to measure various liver parameters without contrast. The study compares these imaging results to the biopsy findings using a standard method called the FLIP algorithm. The goal is to find imaging tests or combinations with at least 90% sensitivity and specificity compared to biopsy. During the study, participants will have liver biopsy and imaging tests done to collect data for comparison. The researchers will assess how well imaging techniques identify fibrosis and steatohepatitis by measuring false positives, false negatives, sensitivity, and specificity. They will also analyze how imaging results relate to clinical and demographic factors and track any incomplete or unreliable imaging tests. Participation involves these assessments at baseline, with safety and accuracy closely monitored throughout the research period.

Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients