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

• Published in: Pediatric radiology Vol. 51; no. 10; pp. 1895 - 1906
• Main Authors: Shah, Chetan C., Spampinato, Maria Vittoria, Parmar, Hemant A., Raslan, Osama A., Tomà, Paolo, Lin, Doris D. M., Vymazal, Josef, Colosimo, Cesare, Enterline, David S.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-09-2021; Springer Nature B.V
• Subjects: Adverse events; Age; Body weight; Brain; Brain Neoplasms; Central nervous system; Child, Preschool; Children; Contrast agents; Contrast media; Contrast Media - adverse effects; Diagnostic systems; EKG; Electrocardiography; Evaluation; Gadolinium; Gadolinium - adverse effects; Heterocyclic Compounds - adverse effects; Humans; Image contrast; Imaging; Infant; Infant, Newborn; Laboratories; Magnetic Resonance Imaging; Medical diagnosis; Medical imaging; Medicine; Medicine & Public Health; Neonates; Neuroimaging; Neuroradiology; Nuclear Medicine; Oncology; Organometallic Compounds - adverse effects; Original; Original Article; Patients; Pediatrics; Radiology; Retrospective Studies; Safety; Ultrasound; Gadolinium-based contrast agent; Magnetic resonance imaging; Central nervous system; Gadoteridol; Children; Diagnostic efficacy; Safety; Contrast
• ISSN: 0301-0449; 1432-1998
• DOI: 10.1007/s00247-021-05069-w

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.