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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Elastogram
2-Point Dixon Magnetic Resonance Imaging
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRE + 2PD MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Image Quality of Magnetic Resonance Elastography (MRE)

Secondary Outcome Measures

Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis
Assessed using Pearson correlation
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).

Full Information

First Posted
October 12, 2007
Last Updated
March 17, 2021
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00543777
Brief Title
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
Official Title
Validation Study of Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2007 (Actual)
Primary Completion Date
January 13, 2020 (Actual)
Study Completion Date
January 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRE + 2PD MRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Elastogram
Other Intervention Name(s)
MRE
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
2-Point Dixon Magnetic Resonance Imaging
Other Intervention Name(s)
2PD MRI
Intervention Description
Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.
Primary Outcome Measure Information:
Title
Overall Image Quality of Magnetic Resonance Elastography (MRE)
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis
Description
Assessed using Pearson correlation
Time Frame
Baseline to end of trial, up to 2 years
Title
Hepatic Steatosis
Description
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).
Time Frame
Baseline to the end of the trial, up to 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haesun Choi, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

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