Phase III Clinical Trial Comparing Iopamidol 250 mgI/mL and Iopamidol 300mgI/mL in Cerebral Angiography: Multicenteric, Randomized and Double Blind Study

ABSTRACT

PURPOSE: To evaluate and compare the safety, tolerance and the image quality of cerebral angiography images with the use of the nonionic monomeric contrast agent, iopamidol at 250 mgI/mL or 300 mgI/mL. MATERIALS AND METHODS: This study was approved by the institutional review board and was performed from December 2005 to March 2006. A total of 90 patients undergoing an elective cerebral angiography were studied during a phase III clinical trial to compare the safety and diagnostic efficacy of iopamidol at 250 mgI/ml and 300 mgI/ml. The overall quality of cerebral angiography images was independently graded into three categories: good, bad and nondiagnostic by two radiologists. RESULTS: The image quality of the cerebral angiography was good in 100% of the patients in both groups. A total of 4.44% of the patients experienced adverse events (4.44% in the iopamidol 250 group and 4.44% in the iopamidol 300 group). No statistically significant differences were observed between the two studied groups for either the proportion of patients with one or more adverse events or the intensity of the adverse events. CONCLUSION: The safety and efficacy (quality of the radiographic diagnostic visualization) of Iopamidol at 250 and 300 mg I/ml did not reveal any significant differences and thus are comparable.