Ioversol 320: a new nonionic, water-soluble contrast medium for body computed tomography clinical trial.

ABSTRACT

An open-label noncomparative clinical study was conducted to evaluate the safety, tolerance, and efficacy of ioversol (Optiray 320), a new low-osmolality nonionic contrast medium used in contrast-enhanced computed tomographic (CT) scanning. Forty-two adult patients who required contrast-enhanced body CT scanning participated in the study. Ioversol was administered to patients undergoing CT of the chest, abdomen, and pelvis. Most of the patients received a dose of 150 mL, with smaller doses administered if a patient weighed less than 50 kg or if a patient had only one functioning kidney. The quality of the CT scans was judged to be diagnostic in all 42 patients in the study, with the quality assessed as excellent in 35 patients and good in seven patients. Ioversol was considered well tolerated by patients in the study, with none reporting any pain from the contrast agent. Only mild or moderate sensations of heat were reported. There were no clinically significant changes in vital signs, and only one mild adverse reaction (determined to be procedure-related) was reported. Ioversol was found to be safe, well tolerated, and efficacious for use in body CT scanning.