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A Japanese, Multicenter, Open-label, Phase 3 Study to Investigate the Safety and Efficacy of Gadobutrol for Contrast-enhanced MR Imaging of the Central Nervous System
http://hdl.handle.net/2241/00143755
http://hdl.handle.net/2241/00143755b321fe3d-1469-456d-aaed-5dd07a94e063
名前 / ファイル | ライセンス | アクション |
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MRMS_15-2-227 (858.1 kB)
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Item type | Journal Article(1) | |||||
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公開日 | 2016-09-01 | |||||
タイトル | ||||||
タイトル | A Japanese, Multicenter, Open-label, Phase 3 Study to Investigate the Safety and Efficacy of Gadobutrol for Contrast-enhanced MR Imaging of the Central Nervous System | |||||
言語 | ||||||
言語 | eng | |||||
資源タイプ | ||||||
資源 | http://purl.org/coar/resource_type/c_6501 | |||||
タイプ | journal article | |||||
著者 |
TANAKA, Akio
× TANAKA, Akio× MASUMOTO, Tomohiko× YAMADA, Haruyasu× KURAUCHI, Masayo× BREUER, Josy |
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著者別名 |
増本, 智彦
× 増本, 智彦 |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Purpose: Gadobutrol 1.0 M is macrocyclic gadolinium-based contrast agent for magnetic resonance imaging (MRI). This multicenter, open-label, phase 3 study aimed to investigate the efficacy and safety of gadobutrol-enhanced versus unenhanced MRI in the visualization and diagnosis of central nervous system (CNS) lesions in Japanese patients. Methods: A total of 223 patients referred for contrast-enhanced MRI of the CNS underwent unenhanced and gadobutrol-enhanced (0.1 mmol/kg body weight) MRI. The unenhanced and combined (unenhanced and enhanced) images were evaluated by three independent readers in a blinded manner for degree of contrast enhancement, border delineation, internal morphology, and number of detected lesions (primary variables), and for primary diagnosis and diagnostic confidence. Final clinical diagnoses were established by an independent truth committee consisting of two neurosurgeons. Sensitivity, specificity, and accuracy were calculated for the detection of malignancy and the preciseness of diagnoses (secondary variables) by comparing the results obtained by the blinded readers and the truth committee. Results: Gadobutrol enhancement significantly improved three visualization parameters in MR images: contrast enhancement, border delineation, and internal morphology (P < 0.0001). Non-inferiority was achieved for mean number of lesions detected. Gadobutrol-enhanced imaging provided significant improvements in sensitivity and accuracy for the detection of malignant disease with no loss in specificity, and also improvements in accuracy of exact match diagnosis and diagnostic confidence. Drug-related adverse events were reported in 6 out of 223 patients (2.7%); all were non-serious. Conclusion: Gadobutrol is an effective and well-tolerated contrast agent for MR imaging of the CNS. |
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書誌情報 |
Magnetic resonance in medical sciences 巻 15, 号 2, p. 227-236, 発行日 2016-04 |
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ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 1347-3182 | |||||
書誌レコードID | ||||||
収録物識別子タイプ | NCID | |||||
収録物識別子 | AA11648770 | |||||
PubMed番号 | ||||||
識別子タイプ | PMID | |||||
関連識別子 | 26687097 | |||||
DOI | ||||||
識別子タイプ | DOI | |||||
関連識別子 | 10.2463/mrms.mp.2015-0083 | |||||
権利 | ||||||
権利情報 | ©2015 Japanese Society for Magnetic Resonance in Medicine | |||||
著者版フラグ | ||||||
値 | publisher | |||||
出版者 | ||||||
出版者 | Japanese Society Magnetic Resonance in Medicine |