PURPOSE: This Swedish multicenter trial was performed on patients with known or suspected lesions of the CNS for which an MR examination using a contrast medium was indicated. A total of 8 MR centers participated in the study to establish the safety and efficacy of Omniscan (gadodiamide injection) in clinical routine using a standard dose of 0.1 mmol Gd/kg b.w. MATERIAL AND METHODS: Seven hundred adult patients who had been referred for MR investigation of suspected CNS lesions were included in the study. Since most patients were examined on an outpatient basis, it was decided to use an explicit questionnaire regarding adverse events that developed within 24 h after examination. The efficacy evaluation involved comparisons of detectability, delineation, and number of lesions before and after injection of Omniscan. RESULTS: No serious or unexpected adverse event was found. There were a total of 70 (10.2%) patients with adverse events, excluding those judged not to be contrast media-related. However, only 15 patients (2.2%) had adverse events that possibly or probably were related to the contrast medium. Usually, the symptoms were headache, dizziness, abnormal taste, and nausea. Two patients complained of itching, but only one developed urticaria. The efficacy was similar to that of other currently used Gd-based MR agents. Lesions were more often seen on T2-weighted images, but the contrast medium improved lesion delineation, contributing to higher certainty in diagnosis, and provided more confidence in excluding suspected abnormality. CONCLUSION: Omniscan was found to be a safe and clinically valuable contrast medium for MR imaging of the CNS.
PURPOSE: This Swedish multicenter trial was performed on patients with known or suspected lesions of the CNS for which an MR examination using a contrast medium was indicated. A total of 8 MR centers participated in the study to establish the safety and efficacy of Omniscan (gadodiamide injection) in clinical routine using a standard dose of 0.1 mmol Gd/kg b.w. MATERIAL AND METHODS: Seven hundred adult patients who had been referred for MR investigation of suspected CNS lesions were included in the study. Since most patients were examined on an outpatient basis, it was decided to use an explicit questionnaire regarding adverse events that developed within 24 h after examination. The efficacy evaluation involved comparisons of detectability, delineation, and number of lesions before and after injection of Omniscan. RESULTS: No serious or unexpected adverse event was found. There were a total of 70 (10.2%) patients with adverse events, excluding those judged not to be contrast media-related. However, only 15 patients (2.2%) had adverse events that possibly or probably were related to the contrast medium. Usually, the symptoms were headache, dizziness, abnormal taste, and nausea. Two patients complained of itching, but only one developed urticaria. The efficacy was similar to that of other currently used Gd-based MR agents. Lesions were more often seen on T2-weighted images, but the contrast medium improved lesion delineation, contributing to higher certainty in diagnosis, and provided more confidence in excluding suspected abnormality. CONCLUSION:Omniscan was found to be a safe and clinically valuable contrast medium for MR imaging of the CNS.