Study to evaluate the product flow, breakdown and elimination ofDOTAREM from the blood and its safety and efficacy in children aged > 2years

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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, according to estimated glomerular
filtration rate calculated based on the Schwartz formula
•Subject whose parents or legal guardian (where applicable) has/have
provided his/her/their fully informed written consent for the
participation of the child in the trial. Parents or guardian must have the
ability to read, understand and willingness to sign the informed consent
form
•Subject with health insurance, according to the local regulatory
requirement
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 known severe liver disease
•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 who received or will receive any investigational product within 7 days before DOTAREM injection or during study participation
•Any condition which, based on the investigator's clinical judgement,
would prevent the subject from participating in all study assessments
and visits

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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