Abstract
BackgroundNeonates and young children require efficacious magnetic resonance imaging (MRI) examinations but are potentially more susceptible to the short- and long-term adverse effects of gadolinium-based contrast agents due to the immaturity of their body functions.ObjectiveTo evaluate the acute safety and diagnostic efficacy of gadoteridol (ProHance) for contrast-enhanced MRI of the central nervous system (CNS) in children ≤2 years of age.Materials and methodsOne hundred twenty-five children ≤2 years old (including 57 children <6 months old) who underwent contrast-enhanced MRI of the CNS with gadoteridol at 0.1 mmol/kg body weight were retrospectively enrolled at five imaging centers. Safety data were assessed for acute/subacute adverse events in the 48 h following gadoteridol administration and, when available, vital signs, electrocardiogram (ECG) and clinical laboratory values obtained from blood samples taken from 48 h before until 48 h following the MRI exam. The efficacy of gadoteridol-enhanced MRI compared to unenhanced MRI for disease diagnosis was evaluated prospectively by three blinded, unaffiliated readers.ResultsThirteen changes of laboratory values (11 mild, 1 moderate, 1 unspecified) were reported as adverse events in 7 (5.6%) patients. A relationship to gadoteridol was deemed possible though doubtful for two of these adverse events in two patients (1.6%). There were no clinical adverse events, no serious adverse events and no clinically meaningful changes in vital signs or ECG recordings. Accurate differentiation of tumor from non-neoplastic disease, and exact matching of specific MRI-determined diagnoses with on-site final diagnoses, was achieved in significantly more patients by each reader following the evaluation of combined pre- and post-contrast images compared to pre-contrast images alone (84.6–88.0% vs. 70.9–76.9%; P≤0.006 and 67.5–79.5% vs. 47.0–66.7%; P≤0.011, respectively).ConclusionGadoteridol at 0.1 mmol/kg body weight is safe, well tolerated and effective for contrast-enhanced MRI of the CNS in children ≤2 years of age.
Highlights
Symptoms or adverse outcomes related to brain gadolinium retention have not been documented following the repeated administration of any gadolinium-based contrast agent (GBCA) [1,2,3,4]
Given that migration toward the use of macrocyclic GBCAs for pediatric magnetic resonance imaging (MRI) applications reflects the belief that these GBCAs are more stable in vivo and safer for potentially more vulnerable pediatric patients who have a longer life expectancy, it follows that a macrocyclic GBCA proven to clear more rapidly from brain and body tissues resulting in lower levels of retained gadolinium might be considered the GBCA of choice for the pediatric population
This Health Insurance Portability and Accountability Act (HIPAA)-compliant study was conducted in accordance with the International Congress on Harmonization, Good Clinical Practice, Food and Drug Administration (FDA) regulations, and ethical principles outlined in the Declaration of Helsinki and all applicable local regulations, and was registered at www.clinicaltrials.gov (NCT03750188)
Summary
Symptoms or adverse outcomes related to brain gadolinium retention have not been documented following the repeated administration of any gadolinium-based contrast agent (GBCA) [1,2,3,4]. Given that migration toward the use of macrocyclic GBCAs for pediatric MRI applications reflects the belief that these GBCAs are more stable in vivo and safer for potentially more vulnerable pediatric patients who have a longer life expectancy, it follows that a macrocyclic GBCA proven to clear more rapidly from brain and body tissues resulting in lower levels of retained gadolinium might be considered the GBCA of choice for the pediatric population This is assuming no differences in safety or efficacy relative to other available macrocyclic GBCAs. Gadoteridol (ProHance; Bracco, Milan, Italy) is a macrocyclic GBCA, recently approved by the United States Food and Drug Administration (FDA) for use in children younger than 2 years of age, including term neonates [8], with r1 relaxivity similar to the r1 relaxivity values of other macrocyclic GBCAs [9]. Neonates and young children require efficacious magnetic resonance imaging (MRI) examinations but are potentially more susceptible to the short- and long-term adverse effects of gadolinium-based contrast agents due to the immaturity of their body functions
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