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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00543777
First received: October 12, 2007
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Procedure: Magnetic Resonance Elastogram
Procedure: 2-Point Dixon Magnetic Resonance Imaging
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation Study of Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Image Quality of Magnetic Resonance Elastography (MRE) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Association between degrees of stiffness measured by MRE in kPa and histopathological grades of fibrosis and steatohepatitis assessed using Pearson correlation.


Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRE + 2PD MRI
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.
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.
Other Name: MRE
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.
Other Name: 2PD MRI

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. 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543777

Contacts
Contact: Haesun Choi, MD 713-745-4693

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Haesun Choi, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Haesun Choi, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00543777     History of Changes
Other Study ID Numbers: 2007-0107, NCI-2011-00492
Study First Received: October 12, 2007
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Liver Diseases
Liver Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 21, 2014