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

Phase 1/Phase 2
Open (Enrolling)
Liver Cancer

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Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Overall Image Qualify of MRE: Degree of stiffness as measured by MRE in kPa and histopathological grades of fibrosis and steatohepatitis

Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

Haesun Choi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

Related Keywords:

  • Liver Cancer
  • 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 Diseases
  • Liver Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030