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

Magnetic Resonance Imaging Clinical Trial

Official title:

DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411201
• Other study ID #: DGD-44-063
• Secondary ID: 2013-003215-21
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2015
• Last updated: October 22, 2015
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Agence Nationale de Sécurité du Médicament et des produits de santéAustria: Federal Office for Safety in Health CareHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Drug:
• DOTAREM
Single intravenous injection of 0.1 mmol/kg body weight

Locations

Country	Name	City	State
Austria	Landes-Frauen-und Kinderklinik Linz	Linz
France	CHU	Bordeaux
France	CHRU	Lille
France	Hôpital de Hautepierre	Strasbourg
France	CHRU	Toulouse
Hungary	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
Poland	Uniwersytecki Szpital Dzieciecy w Lublinie	Lublin
Poland	Instytut Pomnik -Centrum Zdrowia Dziecka	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Countries where clinical trial is conducted

Austria,  France,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC) of DOTAREM in plasma		3 time windows as 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection	No
Primary	Rate constant of the terminal phase of DOTAREM		3 time windows as 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection	No
Primary	Elimination half-life of DOTAREM from plasma		3 time windows as 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection	No
Primary	Total Clearance of DOTAREM from plasma		3 time windows as 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection	No
Primary	Volume of distribution of DOTAREM		3 time windows as 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection	No
Primary	Simulation of plasma concentration of DOTAREM		at 10 and 20 min post-injection	No
Secondary	Adverse events collection		from inclusion to 7 days after injection	Yes
Secondary	MRI lesion visualization at patient level		Pre-injection and post-injection (estimated between 5 and 20 minutes after injection)	No