Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
Status: | Active, not recruiting |
---|---|
Conditions: | Liver Cancer, Cancer, Cancer, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/16/2018 |
Start Date: | September 2007 |
End Date: | September 2020 |
Validation Study of Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
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.
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.
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.
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.
Inclusion Criteria:
1. Group 1. Non-oncologic patients from VAMC in Houston:
2. Biopsy proven or clinically suspected advanced parenchymal liver disease
3. Core biopsies obtained within 1-month of MRI/MRE
4. No treatment affecting the status of liver between MRI/MRE and post-imaging biopsy
5. Signed consent
6. Group 2. Oncologic patients at MDACC:
7. Clinically or radiographically suspected liver damage, hepatic steatosis, hepatitis,
hepatic fibrosis or cirrhosis
8. Surgical or core biopsy scheduled within 4 weeks of MRI/MRE
9. Signed consent
Exclusion Criteria:
1. Claustrophobia
2. Contraindications for MRI
3. Unable to hold a breath
4. Ascites or other clinical or radiographical signs of portal hypertension
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Principal Investigator: Haesun Choi, MD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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