Abstract
The safety and efficacy of intravenous gadodiamide injection, 0.1 mmol/kg body weight, have been evaluated in an open label, noncomparative 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.
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References
Sze G (1992) Contrast agents in MR imaging of the paediatric population: current status and recent advances. Adv MRI Contrast 1: 2–15
Baierl P, Mühlsteffen A, Haustein J, et al (1990) Comparison of plain and GdDTPA-enhanced MR imaging in children. Pediatr Radiol 20: 515–519
Ge HL, Hirsch WL, Wolf GL, et al (1992) Diagnostic role of gadoliniumDTPA in paediatric neuroradiology. A retrospective review of 655 cases. Neuroradiology 34:122–125
Ducou le Pointe H, Haddad S, Silberman B, et al (1994) Legg-Perthes-Calvé disease: staging by MRI using gadolinium. Pediatr Radiol 24: 88–91
Ball WS, Nadel SN, Zimmerman RA, et al (1993) Phase III multicentre clinical investigation to determine the safety and efficacy of gadoteridol in children suspected of having neurologic disease. Radiology 186: 769–774
Sze G, Brant-Zawadzki M, McNamara MT, et al (1993) Use of the magnetic resonance contrast agent gadodiamide in the central nervous system. Results of a multicenter trial. Invest Radiol 28: S49-S55
de Lange EE (1994) Gadodiamide injection - enhanced MR imaging of the body: results of a multicenter trial. Acad Radiol 1: S23-S29
Aslanian V, Lemaignen H, Bunouf P, et al (1995) Evaluation clinique de la tolérance du gadodiamide, nouvel agent de contraste non-ionique pour l'IRM du système nerveux central. J Radiol 76: 431–434
Van Wagoner M, O'Toole M, Worah D, et al (1991) A phase I clinical trial with gadodiamide injection, a nonionic magnetic imaging enhancement agent. In vest Radiol 26: 980–986
Reinton V, Berg KJ, Svaland MG, et al (1994) Pharmacokinetics of gadodiamide injection in patients with moderately impaired renal function. Acad Radiol 1: S56-S61
Latchaw RE (1994) Safety and efficacy of gadodiamide injection administered intravenously to children for contrastenhanced MR of the central nervous system. Acad Radiol 1: S15-S22
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Hanquinet, S., Christophe, C., De Greef, D. et al. Clinical evaluation of gadodiamide injection in paediatric MR imaging. Pediatr Radiol 26, 806–810 (1996). https://doi.org/10.1007/BF01396206
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DOI: https://doi.org/10.1007/BF01396206