Development of an Imaging Biomarker for Hepatic Fibrosis Using Gadoxetate Disodium

Weill Cornell Medicine (WCM)

Status and phase: Unknown; Phase 4

Conditions: Hepatic Fibrosis

Treatments: Procedure: MRI of liver

Study type: Interventional

Funder types: Other

Identifiers

NCT01783314

DI-2010-18 (Other Grant/Funding Number)

1009011259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Normal liver function

Active Comparator group

Description:

Control group. Subjects will obtain MRI of liver.

Treatment:

Procedure: MRI of liver

Hepatitis C

Experimental group

Description:

Subjects with hepatitis C. Subjects will obtain both MRI of liver and limited CT of liver.

Treatment:

Procedure: MRI of liver