Clinical evaluation of gadodiamide injection in paediatric MR imaging

Abstract

The safety and efficacy of intravenous gadodiamide injection, 0.1 mmol/kg body weight, have been evaluated in an open label, non-comparative as to drug, phase III clinical trial in 50 children from 6 months to 13 years of age, referred for MRI requiring the injection of a contrast medium. The central nervous system and other body areas were examined with T1 sequences before and after intravenous injection of the contrast medium. Overall safety was very good and no clinically relevant changes were evident as regards heart rate and venous blood oxygen saturation after injection. No adverse event or discomfort was experienced by conscious patients that could with certainty be related to the contrast medium, but slight movements were observed in two sedated patients that could be related to the injection. Comparing pre- and post-injection images, additional diagnostic information could be obtained from the latter in 41 patients (82%). In these images, the number of lesions detected increased and they were generally better delineated and their size more easily estimated. The results of this trial indicate that gadodiamide injection is safe and effective for MRI examinations in children.

MR contrast agents: Physical and pharmacologic basics

“…In conclusion, while many studies have confirmed the "added value" of contrast-enhanced images for pediatric MRI (97)(98)(99)(100)(101)(102)(103)(104)(105)(106)(107)(108), the question is whether or not routine contrast administration in children is warranted. Given that there appears to be an identical safety profile in the pediatric and adult populations, it seems reasonable to administer Gd-based agents to children in the same basic situations considered for adults, particularly in the evaluation of neoplastic or inflammatory disease.…”

Safety of magnetic resonance imaging contrast agents

“…For children under 2 years of age, the safety of these agents has not been established. However, there have been no adverse clinical events or clinically important trends in vital signs reported in association with the use of MR imaging contrast agents in this patient group (31,57,58). Additional studies are ongoing to address the use of the MR imaging contrast agents in pediatric patients.…”

“…Many studies have documented the impressively high safety index of MR imaging contrast agents, especially compared with the iodinated contrast media used for computed tomography (3,13,14,(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)49,(56)(57)(58)(59)(60)(61)66). However, one should bear in mind the considerably different volumes administered for MR contrast compared with those used for the typical contrast-enhanced computed tomography (CT) examination.…”

“…At present, the use of MR imaging contrast agents in pediatric patients over 2 years of age is approved for Magnevist, Omniscan, and ProHance (57,58). Magnevist and Omniscan are approved for usage in children over age 2 for body applications as well (excluding the heart).…”

Off-label use and reimbursement of contrast media in MR

“…This is at odds with clinical practice. The published literature contains clinical trials establishing safety and guidelines for use [21][22][23][24][25][26]. A dose less than 0.1 mmol/kg may be adequate in the infant, particularly under the age of 6 months.…”