Safety and diagnostic efficacy of gadoteridol for magnetic resonance imaging of the brain and spine in children 2 years of age and younger

Abstract

Background 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. Objective To 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 methods One 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. Results Thirteen 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). Conclusion Gadoteridol 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.

Kontrastna sredstva na bazi gadolinija u pedijatrijskoj populaciji

“…None of these reactions could be attributed solely to gadoterate meglumine due to previously used sedative agents. The majority of reported immediate adverse events (1.3%) in this study were of mild intensity and physi- (24). Almost all side effects were related to laboratory values, such as elevated platelet levels, mildly decreased hemoglobin, mildly decreased hemoglobin and erythrocyte counts, moderately decreased platelet levels, and mildly elevated blood chloride.…”

Advanced Neuromonitoring Modalities on the Horizon: Detection and Management of Acute Brain Injury in Children

“…Within the last 5 years, several gadolinium contrast agents have received regulatory approval for use in children of all age groups [ 89 – 91 ]. The potential risks of gadolinium contrast administration may be offset by improved diagnostic accuracy [ 92 – 94 ], in particular in pediatric stroke when time-to-diagnosis is vital for the prevention of neurological injury and death, and by improved prognostication [ 95 – 97 ]. Alternative contrast agents, including liposomes, micelles, and inorganic nanoparticles (e.g., ferumoxytol), remain an active area of study [ 98 , 99 ].…”