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Study Summary
No. 2007-0107:.......Liver......Haesun Choi......Diagnostic Radiology
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Study Summary Title
Study Summary
Number:		2007-0107
Study Title:Validation Study of Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
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Physician New Patient Referral
Name:Haesun ChoiPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Diagnostic RadiologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-4693
Contact us about clinical trials
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General Information
Disease Group:LiverSupported By:N/A
Phase of Study:Phase I/Phase IIReturn
Visit:		NA
Treatment
Agents:		NoneHome Care:NA
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		NA
Description/
Intervention:		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.
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Study Objectives / Outcomes
      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:
    1. To assess the association between the degree of stiffness as measured by MRE in kPa and histopathological grades of fibrosis and steatohepatitis.

    2. To assess the association between the % fat fraction (FF) measured from 2PD MRI and histopathological grade of hepatosteatosis and steatohapatitis.
      Secondary goal:
      To evaluate the roles of MRE and 2PD MRI in predicting the steatohepatitis.
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Study Status Information
Study Activation / Registration Date:09/10/2007
IRB Review and Approval Date:09/10/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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
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Links
Registration Number: NCT00543777
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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