Henrik J. Michaely, Manuela Aschauer, Hannes Deutschmann, Georg Bongartz, Matthias Gutberlet, Ramona Woitek, Birgit Ertl-Wagner, Walter Kucharczyk, Renate Maria Hammerstingl, Francesco De Cobelli, Martin Rosenberg, Thomas Balzer, Jan Endrikat
- Objective: The aim of this study was to assess the potential risk of gadobutrol-enhanced magnetic resonance imaging (MRI) in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF).
Materials and Methods: We performed a prospective, international, multicenter, open-label study in 55 centers. Patients with moderate to severe renal impairment scheduled for any gadobutrol-enhanced MRI were included. All patients received a single intravenous bolus injection of gadobutrol at a dose of 0.1 mmol/kg body weight. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period.
Results: A total of 908 patients were enrolled, including 586 with moderate and 284 with severe renal impairment who are at highest risk for developing NSF. The mean time since renal disease diagnosis was 1.83 and 5.49 years in the moderate and severe renal impairment cohort, respectively. Overall, 184 patients (20.3%) underwent further contrast-enhanced MRI with other gadolinium-based contrast agents within the 2-year follow-up. No patient developed symptoms conclusive of NSF.
Conclusions: No safety concerns with gadobutrol in patients with moderate to severe renal impairment were identified. There were no NSF cases.
MetadatenAuthor: | Henrik J. Michaely, Manuela Aschauer, Hannes Deutschmann, Georg Bongartz, Matthias Gutberlet, Ramona Woitek, Birgit Ertl-Wagner, Walter Kucharczyk, Renate Maria HammerstinglGND, Francesco De Cobelli, Martin Rosenberg, Thomas Balzer, Jan Endrikat |
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URN: | urn:nbn:de:hebis:30:3-427182 |
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DOI: | https://doi.org/10.1097/RLI.0000000000000307 |
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ISSN: | 0020-9996 |
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Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/27529464 |
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Parent Title (English): | Investigative radiology |
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Publisher: | Lippincott Williams & Wilkins |
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Place of publication: | Philadelphia, Pa. |
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Document Type: | Article |
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Language: | English |
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Year of Completion: | 2017 |
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Date of first Publication: | 2016/12/09 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Release Date: | 2017/01/31 |
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Tag: | NSF; gadobutrol; renal impairment |
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Volume: | 52.2017 |
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Issue: | 1 |
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Page Number: | 6 |
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First Page: | 55 |
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Last Page: | 60 |
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Note: | Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
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HeBIS-PPN: | 451324579 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Licence (German): | Creative Commons - Namensnennung-Nicht kommerziell - Keine Bearbeitung 4.0 |
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