[Evaluation of diagnostic efficacy and clinical tolerability of ioversol in "whole body" computed tomography in children. A non comparative phase III trial].
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).
Panuel
M
M
Service de Radiologie Pédiatrique, Hôpital d'Enfants, CHU Timone, Marseille.
Devred
P
P
Faure
F
F
Bourlière-Najean
B
B
Ternier
F
F
Le Bail
C
C
D000293:Adolescent; D000310:Adrenal Gland Neoplasms / Q000000981:diagnostic imaging; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous; D008297:Male; D009447:Neuroblastoma / Q000000981:diagnostic imaging; D014057:Tomography, X-Ray Computed / Q000379:methods*; D014283:Triiodobenzoic Acids / Q000008:administration & dosage / Q000009:adverse effects; D014388:Tuberculosis, Lymph Node / Q000000981:diagnostic imaging; D014916:Whole-Body Irradiation
D014283:Triiodobenzoic Acids; C054871:ioversol
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.