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Safety and diagnostic efficacy of gadoteridol for magnetic resonance imaging of the brain and spine in children 2 years of age and younger.
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.
Affiliation
  • Shah CC; Pediatric Radiology, Wolfson Children's Hospital, Nemours Children's Health System, 800 Prudential Drive, Jacksonville, FL, 32207, USA. Chetan.Shah@nemours.org.
  • Spampinato MV; Medical University of South Carolina, Charleston, SC, USA.
  • Parmar HA; C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI, USA.
  • Raslan OA; Davis Medical Center, University of California, Sacramento, CA, USA.
  • Tomà P; Bambino Gesù Children's Hospital, Rome, Italy.
  • Lin DDM; Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Vymazal J; Department of Radiology, Na Homolce Hospital, Prague, Czech Republic.
  • Colosimo C; Insitute of Radiology, Radiodiagnostica e Neuroradiologia, Fondazione Policlinico Universitario "A. Gemelli," Universita Cattolica del Sacro Cuore, Rome, Italy.
  • Enterline DS; Duke University School of Medicine, Durham, NC, USA.
Pediatr Radiol ; 51(10): 1895-1906, 2021 Sep.
Article in En | MEDLINE | ID: mdl-33950270
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.
Subject(s)
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Organometallic Compounds / Brain Neoplasms / Heterocyclic Compounds Type of study: Diagnostic_studies / Observational_studies Limits: Child, preschool / Humans / Infant / Newborn Language: En Journal: Pediatr Radiol Year: 2021 Type: Article Affiliation country: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Organometallic Compounds / Brain Neoplasms / Heterocyclic Compounds Type of study: Diagnostic_studies / Observational_studies Limits: Child, preschool / Humans / Infant / Newborn Language: En Journal: Pediatr Radiol Year: 2021 Type: Article Affiliation country: United States