An observational study of the administration of Eovist/Primovist in pediatric subjects (> 2 months and < 18 years) who are referred for a routine contrast enhanced liver MRI because of suspected or known focal liver lesions. (IRB# 34641)
Bayer Healthcare Pharmaceuticals, Inc. is conducting a study in which medical records are reviewed to obtain information about the use of a diagnostic imaging agent called Eovist/Primovist in children older than 2 months and less than 18 years.
- Age >2 months and <18 years of age at the time of the Eovist/Primovist enhanced MRI
- MRI with Eovist/Primovist due to suspected or known focal liver lesions
- Evaluable safety data
- Evaluable efficacy data: precontrast and postcontrast magnetic resonance (MR) images must be available for review
Additional Study Details:
This study only involves collection of data. There are no additional tests or hospital visits required. Only data that has been recorded in the medical records related to the injection of Eovist/Primovist will be collected. Data will be collected from up to 2 weeks before the participant received Eovist/Primovist until 12 months after they received Eovist/Primovist.
At the end of the study observation period (12 months after the Eovist/Primovist MRI) participants may be contacted by telephone, by the participant's study doctor to ask if there were any serious side effects since the time of the Eovist/Primovist MRI.
Penn State Hershey Medical Center