Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging

overview of clinical trials and post-marketing studies

Csilla Balassy, Donna Roberts, Stephen Miller

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1831-1841
Number of pages11
JournalPediatric radiology
Volume45
Issue number12
DOIs
StatePublished - Nov 1 2015

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Marketing
Meta-Analysis
Magnetic Resonance Imaging
Pediatrics
Safety
Acids
Pharmacovigilance
Contrast Media
Observational Studies
Central Nervous System
Whole Body Imaging
Gadolinium
Clinical Trials
Therapeutics

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Radiology Nuclear Medicine and imaging

Cite this

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging : overview of clinical trials and post-marketing studies. / Balassy, Csilla; Roberts, Donna; Miller, Stephen.

In: Pediatric radiology, Vol. 45, No. 12, 01.11.2015, p. 1831-1841.

Research output: Contribution to journalArticle

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