Methods to Detect Liver Fibrosis

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03027700
Study type	Interventional
Source	Children's Hospital Medical Center, Cincinnati
Contact
Status	Terminated
Phase	N/A
Start date	January 26, 2017
Completion date	December 30, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.