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Prospective Safety Study of Intrathecal Gadobutrol in Different Doses

Prospective Safety Study of Intrathecal Gadobutrol in Different Doses BACKGROUND AND PURPOSE: In our clinical practice, we increasingly use intrathecal contrast-enhanced glymphatic MR imaging to assess CSF disturbances. However, because intrathecal MR imaging contrast agents such as gadobutrol (Gadovist; 1.0 mmol/mL) are used off-label, a thorough understanding of the safety profile is required. MATERIALS AND METHODS: We performed a prospective safety study from August 2020 to June 2022 of intrathecal gadobutrol, including consecutive patients who received either 0.50, 0.25, or 0.10 mmol. Serious and nonserious adverse events were recorded systematically at 1–3 days, 4 weeks, and >6 months after the intrathecal administration. RESULTS: The study included 196 patients who received intrathecal gadobutrol, including patients assessed for idiopathic normal pressure hydrocephalus (iNPH, n = 144) or patients examined for other CSF disorders (non-iNPH cohort; n = 52). The intrathecal gadobutrol doses were either 0.50 mmol ( n = 56), 0.25 mmol ( n = 111), or 0.10 mmol ( n = 29). No serious adverse events were observed. Nonserious adverse events on days 1–3 after intrathecal gadobutrol were, to some degree, dose-dependent but mild-to-moderate, including severe headache, nausea, and/or dizziness in 6/196 (6.3%) patients, and they were more common in the non-iNPH than in the iNPH cohort. At 4 weeks, none reported severe nonserious adverse events, and 9/179 (5.0%) patients had mild-to-moderate symptoms. After >6 months, 2 patients reported mild headache. CONCLUSIONS: The present study adds to the accumulating evidence that intrathecal gadobutrol in doses up to 0.50 is safe. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Neuroradiology American Journal of Neuroradiology

Prospective Safety Study of Intrathecal Gadobutrol in Different Doses

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References (28)

Publisher
American Journal of Neuroradiology
Copyright
© 2023 by American Journal of Neuroradiology
ISSN
0195-6108
eISSN
1936-959X
DOI
10.3174/ajnr.a7841
Publisher site
See Article on Publisher Site

Abstract

BACKGROUND AND PURPOSE: In our clinical practice, we increasingly use intrathecal contrast-enhanced glymphatic MR imaging to assess CSF disturbances. However, because intrathecal MR imaging contrast agents such as gadobutrol (Gadovist; 1.0 mmol/mL) are used off-label, a thorough understanding of the safety profile is required. MATERIALS AND METHODS: We performed a prospective safety study from August 2020 to June 2022 of intrathecal gadobutrol, including consecutive patients who received either 0.50, 0.25, or 0.10 mmol. Serious and nonserious adverse events were recorded systematically at 1–3 days, 4 weeks, and >6 months after the intrathecal administration. RESULTS: The study included 196 patients who received intrathecal gadobutrol, including patients assessed for idiopathic normal pressure hydrocephalus (iNPH, n = 144) or patients examined for other CSF disorders (non-iNPH cohort; n = 52). The intrathecal gadobutrol doses were either 0.50 mmol ( n = 56), 0.25 mmol ( n = 111), or 0.10 mmol ( n = 29). No serious adverse events were observed. Nonserious adverse events on days 1–3 after intrathecal gadobutrol were, to some degree, dose-dependent but mild-to-moderate, including severe headache, nausea, and/or dizziness in 6/196 (6.3%) patients, and they were more common in the non-iNPH than in the iNPH cohort. At 4 weeks, none reported severe nonserious adverse events, and 9/179 (5.0%) patients had mild-to-moderate symptoms. After >6 months, 2 patients reported mild headache. CONCLUSIONS: The present study adds to the accumulating evidence that intrathecal gadobutrol in doses up to 0.50 is safe.

Journal

American Journal of Neuroradiology – American Journal of Neuroradiology

Published: May 1, 2023

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