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

Guerbet51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Magnetic Resonance Imaging

Interventions

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

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

Locations (9)

Landes-Frauen-und Kinderklinik Linz

Linz, Austria

CHU

Bordeaux, France

CHRU

Lille, France

Hôpital de Hautepierre

Strasbourg, France

Department of Molecular and Neurological Clinical and Research Center

Budapest, Hungary

University of Debrecen Medical Center

Debrecen, Hungary

Borsod-Abaúj-Zemplén University County Hospital

Miskolc, Hungary

Uniwersytecki Szpital Dziecięcy w Lublinie

Lublin, Poland

Instytut Pomnik -Centrum Zdrowia Dziecka

Warsaw, Poland

Outcomes

Primary Outcomes

Area Under the Curve of DOTAREM in Plasma

Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Area under the curve was determined from typical and individual DOTAREM concentration-time profiles.