Development of an Imaging Biomarker for Hepatic Fibrosis Using Gadoxetate Disodium

Phase 4

• Conditions: Hepatic Fibrosis
• Interventions: Procedure: MRI of liver

• Registration Number: NCT01783314
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-11-18
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Study First Posted: 2013-02-04
• Last Update Posted: 2013-02-04
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal liver function	MRI of liver	Control group. Subjects will obtain MRI of liver.
Hepatitis C	MRI of liver	Subjects with hepatitis C. Subjects will obtain both MRI of liver and limited CT of liver.

Primary Outcome Measures

Name	Time	Method
The transfer constant, Ktrans, between intravascular and interstitial compartments.	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.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States