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

Stopped early · Phase 3

Conditions studied: Magnetic Resonance Imaging

In brief

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.

Key facts

Study ID

NCT02084628

Run by

Bayer

People needed

1

Starts

2015-02-01

Expected to finish

2015-08-01

Last updated by the study team

2016-09-23

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Brooklyn, New York, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Seattle, Washington, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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