Merete Halvorsen1, Camilla Sæthre Edeklev1, Jorunn Fraser-Green2, Grethe Løvland2, Svein Are Sirirud Vatnehol2, Øivind Gjertsen3, Bård Nedregaard3, Ruth Sletteberg3, Geir Ringstad3, Per Kristian Eide4,5. 1. Department. of Neurosurgery, Oslo University Hospital - Rikshospitalet, Postboks 4950 Nydalen, 0424, Oslo, Norway. 2. The Interventional Centre, Oslo University Hospital - Rikshospitalet, Oslo, Norway. 3. Dept. of Radiology and Nuclear Medicine, Oslo University Hospital - Rikshospitalet, Oslo, Norway. 4. Department. of Neurosurgery, Oslo University Hospital - Rikshospitalet, Postboks 4950 Nydalen, 0424, Oslo, Norway. p.k.eide@medisin.uio.no. 5. Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway. p.k.eide@medisin.uio.no.
Abstract
PURPOSE: Magnetic resonance imaging (MRI) contrast agents have been used off-label for diagnosis of cerebrospinal fluid (CSF) leaks and lately also for assessment of the glymphatic system and meningeal lymphatic drainage. The purpose of this study was to further evaluate the short- and long-term safety profile of intrathecal MRI contrast agents. METHODS: In this prospective study, we compared the safety profile of different administration protocols of intrathecal gadobutrol (GadovistTM; 1.0 mmol/ml). Gadobutrol was administered intrathecal in a dose of 0.5 mmol, with or without iodixanol (VisipaqueTM 270 mg I/ml; 3 ml). In addition, a subgroup was given intrathecal gadobutrol in a dose of 0.25 mmol. Adverse events were assessed at 1 to 3 days, 4 weeks, and after 12 months. RESULTS: Among the 149 patients, no serious adverse events were seen in patients without history of prior adverse events. The combination of gadobutrol with iodixanol did not increase the occurrence of non-serious adverse events after days 1-3. Intrathecal gadobutrol in a dose of 0.25 mmol caused less severity of nausea, as compared with the dose of 0.5 mmol. The clinical diagnosis was the major determinant for occurrence of non-serious adverse events after intrathecal gadobutrol. CONCLUSION: This prospective study showed that intrathecal administration of gadobutrol in a dose of 0.5 mmol is safe. Non-serious adverse events were to a lesser degree affected by the administration protocols, though preliminary data are given that side effects of intrathecal gadobutrol are dose-dependent.
PURPOSE: Magnetic resonance imaging (MRI) contrast agents have been used off-label for diagnosis of cerebrospinal fluid (CSF) leaks and lately also for assessment of the glymphatic system and meningeal lymphatic drainage. The purpose of this study was to further evaluate the short- and long-term safety profile of intrathecal MRI contrast agents. METHODS: In this prospective study, we compared the safety profile of different administration protocols of intrathecal gadobutrol (GadovistTM; 1.0 mmol/ml). Gadobutrol was administered intrathecal in a dose of 0.5 mmol, with or without iodixanol (VisipaqueTM 270 mg I/ml; 3 ml). In addition, a subgroup was given intrathecal gadobutrol in a dose of 0.25 mmol. Adverse events were assessed at 1 to 3 days, 4 weeks, and after 12 months. RESULTS: Among the 149 patients, no serious adverse events were seen in patients without history of prior adverse events. The combination of gadobutrol with iodixanol did not increase the occurrence of non-serious adverse events after days 1-3. Intrathecal gadobutrol in a dose of 0.25 mmol caused less severity of nausea, as compared with the dose of 0.5 mmol. The clinical diagnosis was the major determinant for occurrence of non-serious adverse events after intrathecal gadobutrol. CONCLUSION: This prospective study showed that intrathecal administration of gadobutrol in a dose of 0.5 mmol is safe. Non-serious adverse events were to a lesser degree affected by the administration protocols, though preliminary data are given that side effects of intrathecal gadobutrol are dose-dependent.
Authors: Alexander Radbruch; Robert Haase; Pascal J Kieslich; Lukas D Weberling; Philipp Kickingereder; Wolfgang Wick; Heinz-Peter Schlemmer; Martin Bendszus Journal: Radiology Date: 2016-12-07 Impact factor: 11.105
Authors: Vikas Gulani; Fernando Calamante; Frank G Shellock; Emanuel Kanal; Scott B Reeder Journal: Lancet Neurol Date: 2017-06-13 Impact factor: 44.182
Authors: Per Kristian Eide; Lars Magnus Valnes; Erika Kristina Lindstrøm; Kent-Andre Mardal; Geir Ringstad Journal: Fluids Barriers CNS Date: 2021-04-01
Authors: Per Kristian Eide; Aslan Lashkarivand; Åsmund Aleksander Hagen-Kersten; Øivind Gjertsen; Bård Nedregaard; Ruth Sletteberg; Grethe Løvland; Svein Are Sirirud Vatnehol; Are Hugo Pripp; Lars Magnus Valnes; Geir Ringstad Journal: Front Neurol Date: 2022-04-06 Impact factor: 4.086
Authors: Per K Eide; Espen Mariussen; Hilde Uggerud; Are H Pripp; Aslan Lashkarivand; Bjørnar Hassel; Hege Christensen; Markus Herberg Hovd; Geir Ringstad Journal: JCI Insight Date: 2021-05-10