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

Status and phase: Terminated; Phase 3

Conditions: Magnetic Resonance Imaging

Treatments: Drug: Gadoxetate disodium (Eovist/Primovist, BAY86-4873)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02084628

16078

2012-000952-32 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

In order to minimize bias in assessment of the images, blinded reading of the MR images will be performed by 2 blinded readers. The blinded readers will be independent board-certified pediatric radiologists who have no knowledge about the subjects and are not affiliated with any of the clinical sites.

Enrollment: 1 patient

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Gadoxetate disodium (Eovist/Primovist, BAY86-4873)

Experimental group

Description:

Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole \[mmol\]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent \[%\] solution) manually.

Treatment:

Drug: Gadoxetate disodium (Eovist/Primovist, BAY86-4873)