Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
Central Nervous System Diseases, Pediatric Disorder, Body Indication
About this trial
This is an interventional diagnostic trial for Central Nervous System Diseases
Eligibility Criteria
Main Inclusion Criteria:
- Female or male pediatric patient aged from birth to 23 months of age inclusive (term neonates 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 birth through the expected date of delivery plus 27 days. Term is defined as ≥37 completed weeks of amenorrhea,
- Patient with known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging, scheduled to undergo contrast-enhanced MRI of any body region including CNS [...]
Main Exclusion Criteria:
- Patient planned for treatment or procedure (e.g. surgery) that would prevent from obtaining the required blood samples or performing other trial procedures between the screening visit and up to one day after gadopiclenol administration,
- Patient undergoing treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) preceding or subsequent to gadopiclenol administration that would alter gadopiclenol pharmacokinetic parameters,
- Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age-adjusted normal value calculated based on bedside Schwartz equation, [...]
9. Patient undergoing a change in chemotherapy (product or dosage) within one day prior to or one day after gadopiclenol administration, 10. Patient who received or will receive any other contrast agent for CT and/or MRI within one week prior to or one week after gadopiclenol administration, 11. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker), 12. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents [...]
Sites / Locations
- Cincinnatti Childrens HospitalRecruiting
- Medical University of South CarolinaRecruiting
- Multiprofile Hospital for Active Treatment Central Onco Hospital
- Acibadem City Clinic Tokuda Hospital
- Semmelweis EgyetemRecruiting
- Országos Idegtudományi IntézetRecruiting
- University of Debrecen Clinical Center Pediatric DepartmentRecruiting
- Szpital Uniwersytecki nr 1 im. dr Antoniego JuraszaRecruiting
- Instytut Centrum Zdrowia Matki PolkiRecruiting
- Uniwersytecki Szpital DzieciecyRecruiting
- Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi KrolowejRecruiting
- Uniwersyteckie Centrum Kliniczne WarszawskiegoRecruiting
- Instytut "Pomnik - Centrum Zdrowia Dziecka"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Age Group 1: patients aged 3 to 23 months
Age Group 2: patients aged 28 days to less than 3 months
Age Group 3: patients aged from birth to 27 days (term newborns)
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.