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.

• Authors: Chetan C Shah, Maria Vittoria Spampinato, Hemant A Parmar, Osama A Raslan, Paolo Tomà, Doris D M Lin, Josef Vymazal, Cesare Colosimo, David S Enterline
• Journal: Pediatric radiology (Pediatr Radiol) Vol. 51 Issue 10 Pg. 1895-1906 (Sep 2021) ISSN: 1432-1998 [Electronic] Germany
• PMID: 33950270 (Publication Type: Journal Article)
• Copyright: © 2021. The Author(s).

Chemical References

• Contrast Media
• Heterocyclic Compounds
• Organometallic Compounds
• gadoteridol
• Gadolinium

Topics

• Brain
• Brain Neoplasms
• Child, Preschool
• Contrast Media (adverse effects)
• Gadolinium (adverse effects)
• Heterocyclic Compounds (adverse effects)
• Humans
• Infant
• Infant, Newborn
• Magnetic Resonance Imaging
• Organometallic Compounds (adverse effects)
• Retrospective Studies