Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease

Study Overview
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Brief Summary
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The goal of this clinical research study is to test the accuracy of magnetic resonance elastogram (MRE) and 2-point dixon magnetic resonance imaging (2PD MRI) using new computer software (called phase correction algorithm) in patients who might have liver disease.

Detailed Description
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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. 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.

Official Title
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Validation Study of Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease

Conditions
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Liver Cancer

Intervention / Treatment
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* Diagnostic Test: Magnetic Resonance Elastogram
* Diagnostic Test: 2-Point Dixon Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1. Non-oncologic patients from VAMC in Houston: Biopsy proven or clinically suspected advanced parenchymal liver disease Core biopsies obtained within 1-month of MRI/MRE No treatment affecting the status of liver between MRI/MRE and post-imaging biopsy Signed consent Group 2. Oncologic patients at MDACC: Clinically or radiographically suspected liver damage, hepatic steatosis, hepatitis, hepatic fibrosis or cirrhosis Surgical or core biopsy scheduled within 4 weeks of MRI/MRE Signed consent Exclusion Criteria: Claustrophobia Contraindications for MRI Unable to hold a breath Ascites or other clinical or radiographical signs of portal hypertension
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRE + 2PD MRI<br>MRE - Pneumatic driver will be placed over the upper abdomen. Patient 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. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue. | Diagnostic Test: Magnetic Resonance Elastogram<br>* Pneumatic driver will be placed over the upper abdomen. Patient 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.<br>* Other names: MRE;Diagnostic Test: 2-Point Dixon Magnetic Resonance Imaging<br>* Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.<br>* Other names: 2PD MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Image Quality of Magnetic Resonance Elastography (MRE) |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis | Assessed using Pearson correlation | Baseline to end of trial, up to 2 years | 
| Hepatic Steatosis | Development of a non-invasive means to quantify hepatic steatosis using 2-Point Dixon technique for patients with >30% steatosis compared to participants with <30% steatosis. The degree of steatosis was quantified by percent fat fraction (%FF). | Baseline to the end of the trial, up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cancer, Magnetic Resonance Elastography, 2-Point Dixon Magnetic Resonance Imaging, Liver Disease, Fatty Liver, Liver Fibrosis, Liver Cirrhosis, MRE, 2PD MRI, phase correction algorithm