Recruiting

Imaging Biomarker

Sponsor:

Weill Medical College of Cornell University

Code:

NCT01783314

Conditions

Hepatic Fibrosis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

MRI of liver

Study Details

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

Study ID

NCT01783314

Start date

Dec, 2010

Status verified date

Jan, 2013

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Normal liver function

Control group. Subjects will obtain MRI of liver.

experimental: Hepatitis C

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

Interventions

MRI of liver

MRI of liver with intravenous gadoxetate disodium

Primary outcome measure

  • The transfer constant, Ktrans, between intravascular and interstitial compartments. [ Time Frame: up to 3 years ]

Central Contacts and Locations

Central contacts

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

Krishna Juluru, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 4, 2013

Last verified

Jan, 2013

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2013-02-04.