stop_circleTerminated/Withdrawn

Magnetic Resonance Imaging

Bayer Identifier:

16078

ClinicalTrials.gov Identifier:

NCT02084628

EudraCT Number:

2012-000952-32

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Both

Age

0 - 2 Months
  • - 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
  • - 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
February 2015 - August 2015
Phase
Phase 3
Could I Receive a placebo
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
New York, 10032, United States
Terminated
Philadelphia, 19104, United States
Terminated
Palo Alto, 94304, United States
Terminated
Los Angeles, 90027-6089, United States
Terminated
Madison, 53792, United States
Terminated
Brooklyn, 11219, United States
Terminated
Seattle, 98105, United States
Terminated
Washington, 20010, United States
Terminated
Cincinnati, 45229, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 24 hours after injection
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 6 months after injection
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of lesions detected for the pre-contrast images
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of lesions detected for the combined images
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with contrast enhancement of the biliary system for the combined images
    If relevant to the subject
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with visualization of the biliary system for the pre-contrast images
    If relevant to the subject
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with visualization of the biliary system for the combined images
    If relevant to the subject
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with diagnostic confidence for the pre-contrast images
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with diagnostic confidence for the pre-contrast images
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with diagnostic confidence for the combined images
    date_rangeTime Frame:
    Up to 1 year after injection
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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