Phase 4
Completed N=51
DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years
Magnetic Resonance Imaging
Source: ClinicalTrials.gov NCT02411201 ↗
Enrolled (actual)
51
Serious AEs
2.2%
Results posted
Mar 2017
Primary outcomePrimary: Area Under the Curve of DOTAREM in Plasma — 1591.1 hour.µmol/L
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve of DOTAREM in Plasma |
1591.1 | — |
| PRIMARY Rate Constant of the Terminal Phase of DOTAREM |
0.5117 | — |
| PRIMARY Terminal Elimination Half-life of DOTAREM From Plasma |
1.3545 | — |
| PRIMARY Total Clearance of DOTAREM From Plasma |
0.0602 | — |
| PRIMARY Volume of Distribution of DOTAREM at Steady State |
0.0473 | — |
| SECONDARY Simulated Plasma Concentration of DOTAREM |
320.92; 275.67 | — |
| SECONDARY MRI Lesion Visualization at Subject Level |
4.3; 5.1; 4.3; 5.2; 1.9; 5.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02411201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.