Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than 18 years. Data that has been recorded in the child's medical records relating to the injection of Primovist/Eovist will be collected. Information will be collected from up to 2 weeks before the child received Primovist/Eovist until 12 months after the child received Primovist/Eovist. Copy of the child's MR images that were taken right before and after the child received Primovist/Eovist and all other reports (laboratory reports, other imaging reports, etc) that are part of the child's medical records during that time period will be collected.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point
Timeframe: 14 days prior to Eovist/Primovist MRI
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection
Timeframe: Up to 24 hours post-Eovist/Primovist MRI
Vital Signs: Mean Change From Baseline in Heart Rate
Timeframe: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Vital Signs: Mean Change From Baseline in Systolic Blood Pressure
Timeframe: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure
Timeframe: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI