Development of an Imaging Biomarker for Hepatic Fibrosis Using Gadoxetate Disodium

Status unconfirmed · Phase 4

Conditions studied: Hepatic Fibrosis

In brief

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.

Key facts

Study ID

NCT01783314

Run by

Weill Medical College of Cornell University

People needed

40

Starts

2010-12-01

Expected to finish

2014-12-01

Last updated by the study team

2013-02-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Weill Cornell Medical College — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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