Tolerance and efficacy of Omniscan (gadodiamide injection) in MR imaging of the central nervous system

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

Development of a European Organization for Research and Treatment of Cancer (EORTC) questionnaire module to be used in quality of life assessments in head and neck cancer patients

A head and neck cancer specific questionnaire module designed to be used in quality of life assessments before, during, and after radiotherapy and surgery, with or without combinations with chemotherapy has been developed in accordance with guidelines given by the EORTC Quality of Life Study Group. Relevant issues were generated by means of literature search, and interviews with specialists and patients. Pre-testing of a preliminary questionnaire module was performed in patients from Norway, Sweden, Denmark, United Kingdom and French-speaking Belgium. The resulting head and neck cancer module, the EORTC QLQ-H&n37, includes 37 items concerning disease and treatment related symptoms, social function and sexuality. By using a combination of the general EORTC QLQ-C30 and the EORTC QLQ-H&n37, health-related quality of life measurements may be compared between studies in different cancer populations, and still be sensitive to changes in the target population. ©1994 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.SCOPUS: ar.jinfo:eu-repo/semantics/publishe