Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age

Main Inclusion Criteria:

1. Female or male pediatric patient aged from birth to 23 months of age inclusive (termneonates for all age groups or preterm infants after the neonatal period for groups 1 or 2). The neonatal period for preterm newborns is defined as the day of birththrough the expected date of delivery plus 27 days. Term is defined as ≥37 completedweeks of amenorrhea,

2. Patient with known or highly suspected abnormalities/ lesion(s), scheduled toundergo contrast-enhanced MRI of any body region including CNS [...]

Main Exclusion Criteria:

1. Patient planned for treatment or procedure (e.g. surgery) that would prevent fromobtaining the required blood samples or performing other trial procedures betweenthe screening visit and up to one day after gadopiclenol administration,

2. Patient undergoing treatment or procedure (e.g., diuretics, clinically significantblood loss or blood transfusion) preceding or subsequent to gadopiclenoladministration that would alter gadopiclenol pharmacokinetic parameters,

3. Patient with acute or chronic renal insufficiency defined as estimated GlomerularFiltration Rate (eGFR) out of age-adjusted normal value calculated based on bedsideSchwartz equation, [...]

4. Patient undergoing a change in chemotherapy (product or dosage) within one day priorto or one day after gadopiclenol administration, 10. Patient who received or willreceive any other contrast agent for CT and/or MRI within one week prior to or oneweek after gadopiclenol administration, 11. Patient with contraindication for MRIsuch as iron metal implants (e.g., aneurysm clips, pacemaker), 12. Patient withhistory of anaphylactoid or anaphylactic reaction to any allergen including drugsand contrast agents [...]