Safety and Efficacy of Gadoxetate Disodium-Enhanced Liver MRI in Pediatric Patients Aged >2 Months to James Geller  1 , Mureo Kasahara  2 , Mercedes Martinez  3 , Annarosa Soresina  4 , Fran Kashanian  5 , Jan Endrikat  6 Affiliations Expand Affiliations 1 Cincinnati Children's Hospital Medical Center, Cancer and Blood Diseases Institute, Ohio, USA. 2 National Center for Child Health and Development, Organ Transplantation Center 2-10-1, Tokyo, Japan. 3 Department of Pediatrics, Columbia University, Center for Liver Disease and Abdominal Organ Transplantation, New York Presbyterian, NY, USA. 4 A.O. Spedali Civili di Brescia, Immunologia Pediatrica, Clinica Pediatrica Piazzale Spedali Civili, 1, Brescia, Italy. 5 Bayer Pharmaceuticals, Whippany, New Jersey, USA. 6 Bayer Pharma AG, Berlin, Germany.; Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany. PMID: 27478381 PMCID: PMC4957604 DOI: 10.4137/MRI.S39091 Free PMC article Item in Clipboard

James Geller, Mureo Kasahara, Mercedes Martinez, Annarosa Soresina, Fran Kashanian, Jan Endrikat, James Geller, Mureo Kasahara, Mercedes Martinez, Annarosa Soresina, Fran Kashanian, Jan Endrikat

Abstract

Purpose: To assess the safety and efficacy of gadoxetate disodium-enhanced liver MR imaging in pediatric patients.

Material and 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.

Conclusion: Gadoxetate disodium in pediatric patients did not raise any clinically significant safety concern. Contrast enhancement provided additional clinically relevant information.

Keywords: Gadoxetate disodium; MRI; liver imaging; pediatric patients.

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