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

Ekholm, S ; Jonsson, E ; Sandvik, L ; Fagerlund, M ; Holtås, Stig LU ; Isberg, B ; Lindell, D ; Linden, B ; Sjöberg, S and Thuomas, K A , et al. (1996) In Acta Radiologica 37(2). p.223-228
Abstract
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... (More)
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. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Acta Radiologica
volume
37
issue
2
pages
223 - 228
publisher
SAGE Publications
external identifiers
  • pmid:8600967
  • scopus:0030094504
ISSN
1600-0455
language
English
LU publication?
yes
id
7ad9a57d-07a2-4df6-b9ca-559badb034ae (old id 1110458)
date added to LUP
2016-04-01 16:40:57
date last changed
2022-01-28 21:23:10
@article{7ad9a57d-07a2-4df6-b9ca-559badb034ae,
  abstract     = {{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.}},
  author       = {{Ekholm, S and Jonsson, E and Sandvik, L and Fagerlund, M and Holtås, Stig and Isberg, B and Lindell, D and Linden, B and Sjöberg, S and Thuomas, K A and Tollesson, P O}},
  issn         = {{1600-0455}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{223--228}},
  publisher    = {{SAGE Publications}},
  series       = {{Acta Radiologica}},
  title        = {{Tolerance and efficacy of Omniscan (gadodiamide injection) in MR imaging of the central nervous system}},
  volume       = {{37}},
  year         = {{1996}},
}