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

Magnetic Resonance Imaging Clinical Trial

Official title:

Open-label, Multi-center Study to Evaluate the Safety, Efficacy, and Plasma Gadolinium Concentrations After an Intravenous Injection of 0.1 mL/kg Body Weight Eovist/Primovist for Enhanced Magnetic Resonance Imaging (MRI) of the Liver in Children 0 to 2 Months of Age

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02084628
• Other study ID #: 16078
• Secondary ID: 2012-000952-32
• Status: Terminated
• Phase: Phase 3
• First received: February 6, 2014
• Last updated: October 19, 2015
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Months

Eligibility

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.)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Drug:
• Gadoxetate disodium (Eovist/Primovist, BAY 86-4873)
One-time intravenous bolus injection of the study drug 0.1 mL/kg body weight (0.025 mmol/kg BW), administered at a flow rate of 1-2 mL/second
• Sodium chloride solution
Followed by a flush of at least 5 mL saline (sodium chloride 0.9% solution), administered at a flow rate of 1-2 mL/second

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with additional diagnostic information from combined (pre-contrast and post-contrast) compared with pre-contrast images	Number of participants with better: delineation of the border of the lesion, definition of the internal morphology of the lesion, characterization of the lesion, definition of the location of the lesion, assessment of the communication of the lesion with respect to the biliary system and other, specify	Up to 1 year after injection	No
Primary	Number of participants with adverse events as a measure of safety and tolerability		Up to 24 hours after injection	Yes
Primary	Number of participants with serious adverse events as a measure of safety and tolerability		Up to 6 months after injection	Yes
Secondary	Number of lesions detected for the pre-contrast images		Up to 1 year after injection	No
Secondary	Number of lesions detected for the combined images		Up to 1 year after injection	No
Secondary	Number of participants with contrast enhancement of the biliary system for the combined images	If relevant to the subject	Up to 1 year after injection	No
Secondary	Contrast enhancement of the biliary system for the combined images assessed by yes or no question	This is only assessed if it is relevant to the subject	Up to 1 year after injection	No
Secondary	Number of participants with visualization of the biliary system for the pre-contrast images	If relevant to the subject	Up to 1 year after injection	No
Secondary	Number of participants with visualization of the biliary system for the combined images	If relevant to the subject	Up to 1 year after injection	No
Secondary	Number of participants with diagnostic confidence for the pre-contrast images		Up to 1 year after injection	No
Secondary	Number of participants with diagnostic confidence for the combined images		Up to 1 year after injection	No

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