DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®.

DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may take part in the study. In this case they will receive DOTAREM®, a solution injected at the standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet
• Treatments: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Criteria

Inclusion Criteria:

• Pediatric subject aged <2 years (term newborn infants to toddlers 23 months of age inclusive). Term is defined as ≥37 weeks of amenorrhea

• Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region (e.g. CNS, cardiac) at the dose of 0.1 mmol/kg BW (0.2 mL/kg BW)

• Subject with normal renal function for its age, estimated glomerular filtration rate calculated based on the Schwartz formula

Exclusion Criteria:

• Subject planned for intervention (e.g. surgery) between the screening visit and up to 24 hours after DOTAREM injection

• Subject whose preceding or subsequent treatment to DOTAREM injection (e.g., blood loss or receiving blood, treatment with diuretics, etc…) would alter DOTAREM pharmacokinetics parameters

• Subject with subsequent planned treatment after DOTAREM injection that would prevent obtaining the required blood samples (e.g., emergency surgery, etc…)

• Subject with a history of a bleeding disorder

• Subject with severe liver disease (Child's Pugh Classification B or greater or serum direct bilirubin greater than 0.3 mg/dL, age adjusted)

• Subject with electrolyte or fluid imbalance that presents undue risk

• Subject undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after DOTAREM injection

• Subject who received or will receive any other contrast agent within 72 hours prior to DOTAREM injection or up to 24 hours after DOTAREM injection

• Subject with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)

• Subject with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents

• Subject having participated within 30 days in a clinical study involving an investigational drug or device

• Subject planned to participate simultaneously to another clinical study