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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00543777 |
Purpose
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:
-To evaluate the roles of MRE and 2PD MRI in predicting the steatohepatitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Procedure: Magnetic Resonance Elastogram Procedure: 2-Point Dixon Magnetic Resonance Imaging |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Validation Study of Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
MRE + 2PD MRI
|
Procedure: Magnetic Resonance Elastogram
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.
Procedure: 2-Point Dixon Magnetic Resonance Imaging
Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Haesun Choi, MD | 713-745-4693 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Haesun Choi, MD | |
| Principal Investigator: | Haesun Choi, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Haesun Choi, MD/Associate Professor ) |
| Study ID Numbers: | 2007-0107 |
| Study First Received: | October 12, 2007 |
| Last Updated: | January 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00543777 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
|
Liver Neoplasms Liver Diseases Hepatic fibrosis Digestive System Neoplasms Digestive System Diseases |
Fibrosis Liver neoplasms Gastrointestinal Neoplasms Fatty Liver Liver Cirrhosis |
|
Neoplasms Neoplasms by Site |
