Intrathecal use of gadobutrol for glymphatic MR imaging: Prospective safety study of 100 patients

Abstract

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 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.