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Clinical evaluation of gadodiamide injection in paediatric MR imaging
S Hanquinet1, C Christophe, D D Greef
1Department of Radiology, Hôpital Universitaire Cantonal de Pédiatrie, Rue Willy Donzé, 6 CH-1211 Genève 14, Switzerland.
Insights
Gadodiamide injection is a safe and effective contrast agent for pediatric MRI scans. This study found it improved diagnostic information in 82% of children without significant adverse effects.
Area of Science:
- Pediatric Radiology
- Neuroradiology
- Medical Imaging
Background:
- Magnetic Resonance Imaging (MRI) is crucial for diagnosing pediatric conditions.
- Contrast agents enhance MRI image quality and diagnostic yield.
- Gadolinium-based contrast agents are commonly used, necessitating safety and efficacy evaluations in pediatric populations.
Purpose of the Study:
- To evaluate the safety and efficacy of intravenous gadodiamide injection in pediatric patients undergoing MRI.
- To assess the diagnostic utility of gadodiamide in enhancing image quality and lesion detection.
- To determine any clinically relevant changes in vital signs post-injection.
Main Methods:
- An open-label, non-comparative, phase III clinical trial.
- Involved 50 children aged 6 months to 13 years requiring MRI contrast.
- Evaluated safety via vital signs and adverse events; assessed efficacy by comparing pre- and post-contrast T1-weighted MRI sequences.
Main Results:
- Overall safety was very good, with no clinically relevant changes in heart rate or oxygen saturation.
- No adverse events or discomfort were reported in conscious patients; slight movements noted in two sedated patients.
- Post-injection images provided additional diagnostic information in 82% of patients, improving lesion detection and delineation.
Conclusions:
- Intravenous gadodiamide injection is safe and effective for pediatric MRI examinations.
- The contrast agent significantly enhances diagnostic information, aiding in lesion identification and characterization.
- Gadodiamide is well-tolerated in children, supporting its use in this age group.
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.