Development of an Imaging Biomarker for Hepatic Fibrosis Using Gadoxetate Disodium

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01783314
First received: November 18, 2011
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

When someone has hepatitis C or some other condition that causes liver injury, he or she can develop a condition called liver fibrosis that over time, can cause the liver to stop working normally. Currently, the best way to determine the degree of fibrosis is to do a liver biopsy. The investigators hope to show that measuring the degree of liver fibrosis using an MRI with gadoxetate disodium is as good as or better than obtaining this information by performing a liver biopsy. Gadoxetate disodium is a contrast solution given through the veins that is considered safe, is approved for use by the Food and Drug Administration, and is already routinely given to patients with various forms of liver disease, including fibrosis.


Condition Intervention Phase
Hepatic Fibrosis
Procedure: MRI of liver
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Development of an Imaging Biomarker for Hepatic Fibrosis Using Gadoxetate Disodium

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • The transfer constant, Ktrans, between intravascular and interstitial compartments. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Ktrans is a transfer constant obtained following analysis of all images in the MRI exam, and is a measure of the permeability of tissue.


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal liver function
Control group. Subjects will obtain MRI of liver.
Procedure: MRI of liver
MRI of liver with intravenous gadoxetate disodium
Experimental: Hepatitis C
Subjects with hepatitis C. Subjects will obtain both MRI of liver and limited CT of liver.
Procedure: MRI of liver
MRI of liver with intravenous gadoxetate disodium

Detailed Description:

Liver damage, from a variety of causes, leads to a condition called liver fibrosis. Common causes are chronic alcohol use and hepatitis C infection. The condition can progress to cirrhosis and liver failure, and is the seventh leading cause of death in the United States. Presently, biopsy remains the only reliable way to test whether the various treatments that have been proposed are working, but the risks of biopsy preclude frequent re-assessment. Hence, truly personalized treatments are hampered by the lack of a non-invasive, low-risk, but appropriately qualified test by which periodic assessments may be made.

In July of 2008, the FDA approved a new drug called Eovist that is absorbed by liver cells and can be seen in the liver when performing an MRI. The amount and time course of Eovist absorption will be different between health and fibrotic liver tissue. We believe that these parameters, in combination with hematological and immunological blood tests, can predict the degree of liver fibrosis without the need for biopsy. This would allow improved assessment of potentially important interventions that might alter the course of the underlying disease. Thus development of this non-invasive biomarker might not only obviate the need for biopsy, but might in addition allow more intensive periodic assessments that are not possible currently.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • subjects with Hepatitis C who are scheduled to obtain a liver biopsy in the future or have obtained a liver biopsy in the 6 months prior to planned MR imaging or
  • subjects who are healthy, without liver disease (used for normal controls)

All subpopulations regarding gender, race and ethnicity will have equal opportunity for inclusion in the study protocol. The study protocol only includes adult population consistent with the age (>21 years old) at presentation.

Exclusion criteria:

  • subjects with any contraindication to obtaining an MRI with intravenous contrast including: metal in body, severe renal impairment, pregnancy, or breast feeding. Contraindications will be identified using the same screening questionnaire as is provided for routine clinical examinations.
  • Subjects with history of allergy to MRI contrast dye

Severe renal impairment is defined as a glomerular filtration rate (GFR) < 30 mL/min/1.73 m2. All subjects will be screened with a questionnaire. The GFR will be calculated in any subject who reports kidney problems or a history of kidney problems using blood chemistries performed within 6 weeks of the planned date of the MRI examination. These blood chemistries would need to have been performed as part of routine clinical care. A potential subject who reports kidney problems or a history of kidney problems who does not have blood chemistries available within 6 weeks of the MRI examination will be excluded from participation in this study.

  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: NCT01783314

Contacts
Contact: Ame Ng, BSN, CCRP 212-746-2194 ameng@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Ame Ng    212-746-2194    ameng@med.cornell.edu   
Principal Investigator: Krishna Juluru, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Krishna Juluru, MD Weill Medical College of Cornell University
  More Information

Publications:

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01783314     History of Changes
Other Study ID Numbers: 1009011259, DI-2010-18
Study First Received: November 18, 2011
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
hepatic fibrosis
Eovist
gadoxetate disodium
biomarker
liver biopsy
liver function
MRI
Hepatitis C

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Digestive System Diseases
Liver Diseases
Pathologic Processes
Gadolinium ethoxybenzyl DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014