Clinical trial NCT02411201: DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years
Official title: DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Magnetic Resonance Imaging
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 51
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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

Primary outcomes:
measure: Area Under the Curve of DOTAREM in Plasma
timeFrame: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
measure: Rate Constant of the Terminal Phase of DOTAREM
timeFrame: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
measure: Terminal Elimination Half-life of DOTAREM From Plasma
timeFrame: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
measure: Total Clearance of DOTAREM From Plasma
timeFrame: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
measure: Volume of Distribution of DOTAREM at Steady State
timeFrame: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
Secondary outcomes:
measure: Simulated Plasma Concentration of DOTAREM
timeFrame: at 10 and 20 min post-injection
measure: MRI Lesion Visualization at Subject Level
timeFrame: Pre-injection and post-injection (estimated between 5 and 20 minutes after injection)
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Landes-Frauen-und Kinderklinik Linz
city: Bordeaux
country: France
facility: CHU
city: Lille
country: France
facility: CHRU
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Budapest
country: Hungary
facility: Department of Molecular and Neurological Clinical and Research Center
city: Debrecen
country: Hungary
facility: University of Debrecen Medical Center
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén University County Hospital
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Dziecięcy w Lublinie
city: Warszawa
country: Poland
facility: Instytut Pomnik -Centrum Zdrowia Dziecka
Study officials:
affiliation: Guerbet
name: Project Manager
role: STUDY_DIRECTOR
References: