title: Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.
abstract: BACKGROUND
  Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging.
  
  
  OBJECTIVE
  To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies.
  
  
  METHODS
  Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience.
  
  
  RESULTS
  Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern.
  
  
  CONCLUSIONS
  Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.
authors.affiliation: Department of Radiology, Division of General and Pediatric Radiology, Medical University of Vienna, Vienna General Hospital, Waehringer Guertel 18-20, A-1090, Vienna, Austria. csilla.balassy@meduniwien.ac.at.
authors.forename: Csilla
authors.initials: C
authors.lastname: Balassy
authors.affiliation: Department of Radiology, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Donna
authors.initials: D
authors.lastname: Roberts
authors.affiliation: Department of Radiology, LeBonheur Children's Hospital, Memphis, TN, USA.
authors.forename: Stephen F
authors.initials: SF
authors.lastname: Miller
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects*; D005260:Female; D006571:Heterocyclic Compounds / Q000009:adverse effects*; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D007223:Infant; D007231:Infant, Newborn; D008279:Magnetic Resonance Imaging; D008297:Male; D040541:Marketing; D064887:Observational Studies as Topic; D009942:Organometallic Compounds / Q000009:adverse effects*; D015203:Reproducibility of Results
chemical_list: D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C050823:gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
keywords: Children; Contrast media; Gadoteric acid; Magnetic resonance imaging; Safety