Development of an Imaging Biomarker for Hepatic Fibrosis Using Gadoxetate Disodium
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2010 |
| End Date: | December 2014 |
| Contact: | Ame Ng, BSN, CCRP |
| Email: | ameng@med.cornell.edu |
| Phone: | 212-746-2194 |
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.
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.
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.
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.
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.
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