Abstract
PurposeMagnetic 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.MethodsIn 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.ResultsAmong 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.ConclusionThis 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.
Highlights
IntroductionSeveral concerns exist about the off-label intrathecal use of Magnetic resonance imaging (MRI) contrast agents, primarily due to potential neurotoxic effects [8,9,10], and report on retention of linear gadolinium chelates within the human brain extra-vascular space after repeated intravenous administrations [11,12,13]
Since the glia-lymphatic system was described in 2012 [1], it has attracted a lot of interest and scientific discussion by providing a new perspective on brain-wideMH and CSE contributed to this work.Several concerns exist about the off-label intrathecal use of Magnetic resonance imaging (MRI) contrast agents, primarily due to potential neurotoxic effects [8,9,10], and report on retention of linear gadolinium chelates within the human brain extra-vascular space after repeated intravenous administrations [11,12,13]
Several concerns exist about the off-label intrathecal use of MRI contrast agents, primarily due to potential neurotoxic effects [8,9,10], and report on retention of linear gadolinium chelates within the human brain extra-vascular space after repeated intravenous administrations [11,12,13]
Summary
Several concerns exist about the off-label intrathecal use of MRI contrast agents, primarily due to potential neurotoxic effects [8,9,10], and report on retention of linear gadolinium chelates within the human brain extra-vascular space after repeated intravenous administrations [11,12,13]. A potential mechanism for the findings of gadolinium outside the bloodbrain barrier was given by recent observations of MRI contrast agents leaking from blood to CSF [14, 15], even in individuals without blood-brain barrier dysfunction [15, 16], mainly through the choroid plexus [17], and via the ciliary body [16, 18]. Adverse events, categorized as serious or non-serious, were assessed days 1–3 and after 4 weeks and 12 months
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