Development of an Imaging Biomarker for Hepatic Fibrosis Using Gadoxetate Disodium

NCT01783314 | Unknown Phase 4

• 2 other identifiers: 1009011259DI-2010-18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Fibrosis

Keywords

hepatic fibrosis; Eovist; gadoxetate disodium; biomarker; liver biopsy; liver function; MRI; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• The transfer constant, Ktrans, between intravascular and interstitial compartments.

  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

Study Arms (2)

Normal liver function

ACTIVE COMPARATOR

Control group. Subjects will obtain MRI of liver.

Procedure: MRI of liver

Hepatitis C

EXPERIMENTAL

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

Procedure: MRI of liver

Interventions

MRI of liver PROCEDURE

MRI of liver with intravenous gadoxetate disodium

Hepatitis C; Normal liver function

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

Related Publications (36)

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MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis C

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Study Officials

• Krishna Juluru, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ame Ng, BSN, CCRP

CONTACT

212-746-2194; ameng@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: February 4, 2013
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 4, 2013

Record last verified: 2013-01

Locations

US (1)