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Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

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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.

Materials and 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.

Conclusion

Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

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Acknowledgments

The authors wish to thank all the participating sites from these clinical trials and post-marketing observational studies supported by the Guerbet Group.

Conflicts of interest

Drs. Balassy, Roberts and Miller were provided data from published and unpublished studies and post-marketing pharmacovigilance studies by Guerbet. Dr. Roberts has served as a paid consultant for Guerbet but did not receive any support related to this specific paper. Dr. Balassy has received honoraria from Guerbet for speaking engagements but did not receive any support related to this specific paper. Dr. Miller has not received financial support from Guerbet.

Author information

Authors and Affiliations

  1. 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

  2. Department of Radiology, Medical University of South Carolina, Charleston, SC, USA

    Donna Roberts

  3. Department of Radiology, LeBonheur Children’s Hospital, Memphis, TN, USA

    Stephen F. Miller

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  1. Csilla Balassy
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  2. Donna Roberts
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  3. Stephen F. Miller
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Correspondence to Csilla Balassy.

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Balassy, C., Roberts, D. & Miller, S.F. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies. Pediatr Radiol 45, 1831–1841 (2015). https://doi.org/10.1007/s00247-015-3394-9

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  • DOI: https://doi.org/10.1007/s00247-015-3394-9

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