stop_circleTerminated/Withdrawn
Magnetic Resonance Imaging
Bayer Identifier:
16078
ClinicalTrials.gov Identifier:
EudraCT Number:
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.
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
BothAge
0 - 2 MonthsTrial summary
Enrollment Goal
1Trial Dates
February 2015 - August 2015Phase
Phase 3Could I Receive a placebo
NoProducts
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 imagesNumber 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, specifydate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 24 hours after injectionenhanced_encryptionYesSafety Issue:
- Number of participants with serious adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 6 months after injectionenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Number of lesions detected for the pre-contrast imagesdate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
- Number of lesions detected for the combined imagesdate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
- Number of participants with contrast enhancement of the biliary system for the combined imagesIf relevant to the subjectdate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
- Contrast enhancement of the biliary system for the combined images assessed by yes or no questionThis is only assessed if it is relevant to the subjectdate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
- Number of participants with visualization of the biliary system for the pre-contrast imagesIf relevant to the subjectdate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
- Number of participants with visualization of the biliary system for the combined imagesIf relevant to the subjectdate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
- Number of participants with diagnostic confidence for the pre-contrast imagesdate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
- Number of participants with diagnostic confidence for the pre-contrast imagesdate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
- Number of participants with diagnostic confidence for the combined imagesdate_rangeTime Frame:Up to 1 year after injectionenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1