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

Three age groups are defined: * Group 1: patients aged 3 to 23 months (inclusive) * Group 2: patients aged 28 days to less than 3 months; * Group 3: patients aged from birth to 27 days (term newborns). At study set-up, the inclusions started with the oldest patients in group 1 and using an age-down staggered approach. The decision to start the inclusions in group 2 was taken by the Trial Safety Review Board based on safety assessment over one-day period after injection of the first 13 patients in group 1. According to the protocol version 4 (amendments 2 \& 3), the age-down staggered approach was discontinued to allow the inclusions in Group 3 (patients aged from birth to 27 days), simultaneously to inclusions in group 1 and group 2. A total of 3 blood samples per patient were taken post-injection for PK analysis.