[Evaluation of diagnostic efficacy and clinical tolerability of ioversol in "whole body" computed tomography in children. A non comparative phase III trial].

Abstract

An open-label noncomparative clinical study was conducted to evaluate the efficacy and tolerance of ioversol (Optiray 300), a new low-osmolality non ionic contrast medium, in body contrast-enhanced CT scanning in infants and children. Fourty pediatric patients who required contrast-enhanced CT scanning for evaluation of chest, abdominal or pelvic masses participated in the study. The vascular enhancement was judged to be excellent or good in 72.5% of the cases and the CT scans were judged to be diagnostic in 95% of the cases. Ioversol was well tolerated in the study with only two mild adverse reactions (nausea and vomiting, and metallic taste).

• Authors: M Panuel, P Devred, F Faure, B Bourlière-Najean, F Ternier, C Le Bail
• Journal: Annales de radiologie (Ann Radiol (Paris)) Vol. 35 Issue 4 Pt 2 Pg. 280-3 ( 1992) ISSN: 0003-4185 [Print] France
• Vernacular Title: Evaluation de l'efficacité diagnostique et de la tolérance clinique du ioversol en tomodensitométrie "corps entier" chez l'enfant. Essai non comparatif de phase III.
• PMID: 1296492 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article)

Chemical References

• Triiodobenzoic Acids
• ioversol

Topics

• Adolescent
• Adrenal Gland Neoplasms (diagnostic imaging)
• Child
• Child, Preschool
• Female
• Humans
• Infant
• Injections, Intravenous
• Male
• Neuroblastoma (diagnostic imaging)
• Tomography, X-Ray Computed (methods)
• Triiodobenzoic Acids (administration & dosage, adverse effects)
• Tuberculosis, Lymph Node (diagnostic imaging)
• Whole-Body Irradiation