Hepatic Steatosis Clinical Trial
Official title:
Comparison of Non-invasive Methods to Detect and Quantify Liver Fibrosis
The goal of this study is to learn more about liver fibrosis and methods to detect it. We will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and without liver disease.
While liver biopsy is still considered the gold standard for diagnosing and assessing the
presence and degree of liver fibrosis and inflammation, it has disadvantages including the
potential for sampling error and risk of complications, including life-threatening bleeding.
New imaging modalities such as MR Elastography, T1 mapping, T2 mapping, T1 rho, and
magnetization transfer allow rapid, non-invasive evaluation of liver parenchymal
characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the
need for biopsy. To date, the quantitative performance of these different techniques has not
been extensively studied. This study is a single-center trial of non-invasive MR imaging
techniques aimed at detecting and measuring liver fibrosis. Once optimized, these
technologies may later be deployed in hypothesis driven research studies and/or routine
clinical exams in the pediatric population here at CCHMC and/or as part of a multi-center
study with specific IRB approval for that project.
To assess the relative performance of each technique, correlation across techniques, and
reproducibility across the range of fibrosis, 32 subjects will be enrolled in this
preliminary study sub-divided into 4 groups (Group 1: Healthy/ Normal controls; Group 2:
F1/F2 fibrosis as determined by prior biopsy (low grade fibrosis group); Group 3: F3/F4
fibrosis as determined by prior biopsy (high grade fibrosis group), Group 4: Hepatic
steatosis with fibrosis (NAFLD group)). 8 healthy subjects without known or suspected liver
disease will be enrolled as normal controls. 8 subjects each with known fibrosis based on
liver biopsy within the last 6 months will be enrolled in Group 2 and Group 3 (total = 16). 8
subjects with known hepatic steatosis and liver fibrosis based on liver biopsy within the
last 6 months will be enrolled in Group 4.
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