Safety of perfluorobutane (Sonazoid) in characterizing focal liver lesions

Abstract

Background: The purpose of this study was to report the safety of perfluorobutane (Sonazoid) as a vascular-phase imaging agent in characterizing focal liver lesions (FLLs). Materials and Methods: From May 2014 to April 2015, a total of 54 individuals who received Sonazoid contrast-enhanced ultrasound (CEUS) were enrolled at 5 hospitals of 4 medical centers. All individuals were included in safety evaluation. A prospective study to evaluate the adverse effect (AE) incidences after intravenous administration of Sonazoid. Results: Sonazoid was well tolerated. Treatment-emergent adverse events (TEAEs) representing AE were recorded for 13 (24.1%) patients. The most common AE was abdominal pain (9.3%), followed by heart rate irregularity (5.6%). The majority of these patients (69.2%) experienced TEAEs that were mild in intensity. Sonazoid causes no significant AEs after intravenous injection. The only noteworthy AEs are related to tolerable myalgia (3.7%), abdominal pain (1.9%), and headache (1.9%). None of the 54 patients showed serious adverse effects. Conclusion: Sonazoid shows good safety and tolerance of intravenous use during CEUS of the liver for evaluation of FLLs.