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The purpose of the study is to validate the MRE and 2PD MRI technique using the new post-processing phase correction algorithm in evaluating chronic liver disease, specifically the hepatic steatosis, steatohepatitis, hepatic fibrosis, and cirrhosis, in patients with biopsy proven or clinically suspected hepatic steatosis and/or fibrosis. Primary goals:
Secondary goal: 1. To evaluate the roles of MRE and 2PD MRI in predicting the steatohepatitis.
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center: Primary Outcome Measures:
Detailed Description: Finding liver damage as early as possible is important. Traditionally, biopsies have been used for this purpose. Biopsies are accurate but can only check a small part of the liver. Tissue fat and liver stiffness are common in patients with liver disease.This study is testing new MRI techniques (called an MRE) that may be able to test for these symptoms on the entire liver, in a short time. A typical MRI uses a large magnet instead of x-rays to take pictures of the inside of your body. The MRE will be done on a standard MRI scanner. STUDY VISIT: The MRE procedure is useful for identifying tissue stiffness. For the MRE procedure, you will lie on your back on the examination table, and a pneumatic driver (a light-weight, clear plastic drum, about 10 inches wide and 1 inch thick) will be placed over the upper abdomen. You will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. The MRE will take about 40 seconds. The driver will only be turned on during this time. Once the MRE is completed, you will then have a 2PD MRI scan while you are still lying on the table. This procedure is useful in identifying fat tissue. This will take about 20-60 seconds. The total exam time will be no more than 20 minutes, including the preparation time. Once the MRI is completed, you will have a liver biopsy as part of your standard care. You will sign a separate consent form for this procedure. After the biopsy is performed, your participation in the study will be complete. This is an investigational study. The scanners and software for 2PD MRI used for this study are FDA-approved and being used in clinical practice. The MRE technique used for this study has not been FDA-approved. At this time, the MRE technique is being used in research only. You will not be charged for MRE exams for this investigational study. The use of study data for the purpose of this study is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson. Eligibility
Criteria Inclusion Criteria:
Exclusion Criteria:
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00543777 Contacts
Locations
Sponsors and Collaborators
Investigators
More Information
Keywords provided by M.D. Anderson Cancer Center:
Study placed in the following topic categories:
Additional relevant MeSH terms:
Source: National Library of Medicine (NLM) July 08, 2008 |
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