Development of an Imaging Biomarker for Hepatic Fibrosis Using Gadoxetate Disodium

January 31, 2013 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical College
        • Contact:
        • Principal Investigator:
          • Krishna Juluru, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The transfer constant, Ktrans, between intravascular and interstitial compartments.
Time Frame: up to 3 years
Ktrans is a transfer constant obtained following analysis of all images in the MRI exam, and is a measure of the permeability of tissue.
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Krishna Juluru, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1009011259
  • DI-2010-18 (Other Grant/Funding Number: Bayer Healthcare Pharmaceuticals Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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