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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1
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.
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Palo Alto, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Brooklyn, New York, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Seattle, Washington, United States
Unnamed facility
Madison, Wisconsin, United States
Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images
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.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Adverse Events
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.
Time frame: From the signing of the informed consent form until the 6 month post MRI follow-up
Number of Subjects With Serious Adverse Events
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.
Time frame: From the signing of the informed consent form until the 6 month post MRI follow-up
Number of Lesions Detected for the Pre-contrast Images
Time frame: Images were taken pre-injection
Number of Lesions Detected for the Combined Images
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
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)
Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question
Biliary system included 1. Gall bladder 2. Cystic duct 3. Common bile duct 4. Right main bile duct 5. Left main bile duct
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
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)
Change in Diagnosis for the Combined Images Compared With Precontrast Images
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.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question
Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
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