title: Safety and Efficacy of Gadoxetate Disodium-Enhanced Liver MRI in Pediatric Patients Aged >2 Months to <18 Years-Results of a Retrospective, Multicenter Study.
abstract: OBJECTIVE
  To assess the safety and efficacy of gadoxetate disodium-enhanced liver MR imaging in pediatric patients.
  
  
  METHODS
  Retrospective, multicenter study including pediatric patients aged >2 months to <18 years who underwent contrast-enhanced liver MRI due to focal liver lesions. A single intravenous bolus injection of 0.025 to 0.05 mmol/kg body weight of gadoxetate disodium was administered. Adverse events (AEs) up to 24 hours after injection were recorded and a one-year follow-up was conducted for all serious and unexpected AEs. Efficacy was defined based on the additional diagnostic information obtained from the combined (pre- and postcontrast) image sets as compared with the precontrast image sets by blinded reading.
  
  
  RESULTS
  A total of 52 patients for safety and 51 patients for efficacy analyses were evaluated. Twenty-two patients (42.3%) reported a total of 51 serious AEs (SAEs) and one AE after one year. No SAE or AE was related to gadoxetate disodium injection. Gadoxetate disodium-related effects on vital signs were not seen. Additional diagnostic information was obtained for 86.3% of patients. The three most improved efficacy variables were lesion-to-background contrast, lesion characterization, and improved border delineation in 78.4%, 76.5%, and 70.6% of patients, respectively.
  
  
  CONCLUSIONS
  Gadoxetate disodium in pediatric patients did not raise any clinically significant safety concern. Contrast enhancement provided additional clinically relevant information.
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cancer and Blood Diseases Institute, Ohio, USA.
authors.forename: James
authors.initials: J
authors.lastname: Geller
authors.affiliation: National Center for Child Health and Development, Organ Transplantation Center 2-10-1, Tokyo, Japan.
authors.forename: Mureo
authors.initials: M
authors.lastname: Kasahara
authors.affiliation: Department of Pediatrics, Columbia University, Center for Liver Disease and Abdominal Organ Transplantation, New York Presbyterian, NY, USA.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Martinez
authors.affiliation: A.O. Spedali Civili di Brescia, Immunologia Pediatrica, Clinica Pediatrica Piazzale Spedali Civili, 1, Brescia, Italy.
authors.forename: Annarosa
authors.initials: A
authors.lastname: Soresina
authors.affiliation: Bayer Pharmaceuticals, Whippany, New Jersey, USA.
authors.forename: Fran
authors.initials: F
authors.lastname: Kashanian
authors.affiliation: Bayer Pharma AG, Berlin, Germany.; Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Endrikat
keywords: Gadoxetate disodium; MRI; liver imaging; pediatric patients