Trial Condition(s):

Magnetic Resonance Imaging

Magnetic resonance imaging of the liver in children 0-2 months of age with an intravenous injection of Eovist/Primovist which is a contrast agent

Bayer Identifier:

16078

ClinicalTrials.gov Identifier:

NCT02084628

EudraCT Number:

2012-000952-32

Terminated/Withdrawn

Trial Purpose

This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. It has been marketed since 2004 and used in many countries all over the world.
The baby will have blood tests before and after the imaging is done to make sure that there are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours after the injection will be obtained in order to measure how much of the dye is in the blood. The baby will have an intravenous line which can be used for the blood samples and will not need to be stick for the blood samples. Several radiologists will evaluate the images. The family doctor will be contacted to find out what was the diagnosis and treatment after the results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s) will be contacted to make sure the that baby did not have any problems, especially with the skin, joints and eyes.

Inclusion Criteria
- Age 0-2 months (must be gestational age 37 to 41 weeks)
- Scheduled to undergo routine contrast-enhanced liver MRI
- Able to comly with the study procedures
Exclusion Criteria
-  Scheduled for any intervention (except lumbar puncture and bone marrow aspiration) during the study period
- If receiving chemotherapy, may have a change in treatment during the study period
- Contraindication for MRI
- Renal insufficiency (estimated glomerular filtration rate < 80% of age-adjusted normal mean value using the Schwartz formula)
- Acute renal failure
- Clinically relevant abnormal laboratory parameter, ie, greater than 3 times the upper limit of the normal range, in particular, liver enzymes and renal function. (Note: if elevations in liver enzyme levels are consistent with the underlying hepatobiliary disease, then the subject may be enrolled.)

Trial Summary

Enrollment Goal
1
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

New York, United States, 10032

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Terminated
 
Locations

Investigative Site

Palo Alto, United States, 94304

Status
Terminated
 
Locations

Investigative Site

Los Angeles, United States, 90027-6089

Status
Terminated
 
Locations

Investigative Site

Madison, United States, 53792

Status
Terminated
 
Locations

Investigative Site

Brooklyn, United States, 11219

Status
Terminated
 
Locations

Investigative Site

Seattle, United States, 98105

Status
Terminated
 
Locations

Investigative Site

Washington, United States, 20010

Status
Terminated
 
Locations

Investigative Site

Cincinnati, United States, 45229

Status
Terminated
 

Trial Design