Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
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.
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.)
Clareo Health | 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