BACKGROUND AND PURPOSE: Intrathecal contrast-enhanced glymphatic MR imaging has shown promise in assessing glymphatic function in patients with dementia. The purpose of this study was to determine the safety profile and feasibility of this new MR imaging technique. MATERIALS AND METHODS: A prospective safety and feasibility study was performed in 100 consecutive patients (58 women and 42 men, 51 Ϯ 19 years of age) undergoing glymphatic MR imaging from September 2015 to August 2018. Short-and long-term serious and nonserious adverse events were registered clinically and by interview after intrathecal administration of 0.5 mL of gadobutrol (1.0 mmol/mL) along with 3 mL of iodixanol (270 mg I/mL). Adverse events are presented as numbers and percentages. RESULTS: One serious adverse event (anaphylaxis) occurred in a patient with known allergy to iodine-containing contrast agents (1%). The main nonserious adverse events during the first 1-3 days after contrast injection included severe headache (28%) and severe nausea (34%), though the frequency depended heavily on the diagnosis. After 4 weeks, adverse events had resolved. CONCLUSIONS: Intrathecal administration of gadobutrol in conjunction with iodixanol for glymphatic MR imaging is safe and feasible. We cannot conclude whether short-duration symptoms such as headache and nausea were caused by gadobutrol, iodixanol, the lumbar puncture, or the diagnosis. The safety profile closely resembles that of iodixanol alone. ABBREVIATIONS: gMRI ϭ glymphatic MR imaging; iNPH ϭ idiopathic normal pressure hydrocephalus
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 (Gadovist TM ; 1.0 mmol/ml). Gadobutrol was administered intrathecal in a dose of 0.5 mmol, with or without iodixanol (Visipaque TM 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. Nonserious 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.
Background: Hydrocephalus is a chronic illness that often requires lifelong follow-up by healthcare personnel. However, the illness is not well known, and the symptoms are often invisible. This may make it difficult for patients to be taken seriously when interacting with healthcare personnel. The patient perspective in the treatment of hydrocephalus appears to be under-researched.
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