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

Guerbet

Status and phase

Completed

Phase 4

Conditions

Magnetic Resonance Imaging

Treatments

Drug: DOTAREM

Study type

Interventional

Funder types

Industry

Identifiers

NCT02411201

2013-003215-21 (EudraCT Number)

DGD-44-063

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

Under 2 years old

Volunteers

No Healthy Volunteers

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