2389. Safety and Diagnostic Efficacy of Gadoteridol (ProHance) in MRI of the Brain and Spine of Neonates and Infants
Authors * Denotes Presenting Author
  1. Chetan Shah *; Wolfson Children's Hospital
  2. Maria Spampinato; Medical University of South Carolina
  3. Hemant Parmar; University of Michigan
  4. Osama Raslan; University of California - UC Davis
  5. Paolo Tomà; Bambino Gesù Children’s Hospital
  6. David Enterline; Duke University School of Medicine
  7. Gianpaolo Pirovano; Bracco Diagnostics, Inc.
To date no clinical signs, symptoms or adverse outcomes related to brain gadolinium (Gd) retention have been observed following the repeated administration of any gadolinium-based contrast agent (GBCA) (1-4). Nevertheless, there is widespread concern over potential long-term risks associated with Gd retention following GBCA administration. Of the GBCAs available for contrast-enhanced MRI (CE-MRI) of the CNS, gadoteridol (ProHance) has been shown to clear more rapidly following intravenous administration (5-7). CE-MRI provides essential information for pediatric imaging applications. We evaluated the safety and diagnostic efficacy of gadoteridol for contrast enhanced-MRI of the CNS in infants =2 years of age.

Materials and Methods:
125 children of =2 years (including 57 children <6 months) who underwent enhanced MRI of the CNS with gadoteridol at 0.1 mmol/kg bodyweight were retrospectively enrolled at five imaging centers. Safety data were assessed for adverse events (AEs) and, when available, vital signs, ECG and clinical laboratory values obtained from 48 hours before and 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.

Thirteen changes of laboratory values (11 mild, 1 moderate, 1 unspecified) were reported as AEs in 7 (5.6%) patients. A relationship to gadoteridol was deemed possible though doubtful for 2 of these AEs in 2 patients (1.6%). There were no clinical AEs, no serious AEs 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 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).

Gadoteridol at 0.1 mmol/kg bodyweight is safe, well tolerated and effective for contrast-enhanced MRI of the CNS in neonates and infants =2 years of age.