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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02084628
Recruitment Status : Terminated (Enrollment discontinued due to rare medical condition in the age group 0 to 2 months)
First Posted : March 12, 2014
Results First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Magnetic Resonance Imaging Drug: Gadoxetate disodium (Eovist/Primovist, BAY86-4873) Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Gadoxetate disodium (Eovist/Primovist, BAY86-4873)
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.
 Drug: Gadoxetate disodium (Eovist/Primovist, BAY86-4873)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images [ Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes) ]
    Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed.

  2. Number of Subjects With Adverse Events [ Time Frame: From the signing of the informed consent form until the 6 month post MRI follow-up ]
    An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study.

  3. Number of Subjects With Serious Adverse Events [ Time Frame: From the signing of the informed consent form until the 6 month post MRI follow-up ]
    An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.


Secondary Outcome Measures :
  1. Number of Lesions Detected for the Pre-contrast Images [ Time Frame: Images were taken pre-injection ]
  2. Number of Lesions Detected for the Combined Images [ Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes) ]
  3. Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question [ Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes) ]
  4. Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question [ Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes) ]

    Biliary system included

    1. Gall bladder
    2. Cystic duct
    3. Common bile duct
    4. Right main bile duct
    5. Left main bile duct

  5. Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question [ Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes) ]
  6. Change in Diagnosis for the Combined Images Compared With Precontrast Images [ Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes) ]
    Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded.

  7. Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question [ Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes) ]
    Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084628


Locations
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United States, California
Los Angeles, California, United States, 90027-6089
Palo Alto, California, United States, 94304
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, New York
Brooklyn, New York, United States, 11219
New York, New York, United States, 10032
United States, Ohio
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Seattle, Washington, United States, 98105
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02084628    
Other Study ID Numbers: 16078
2012-000952-32 ( EudraCT Number )
First Posted: March 12, 2014    Key Record Dates
Results First Posted: September 23, 2016
Last Update Posted: September 23, 2016
Last Verified: August 2016