Efficacy of Perflubutane Microbubble-Enhanced Ultrasound in the Characterization and Detection of Focal Liver Lesions: Phase 3 Multicenter Clinical Trial

OBJECTIVE. The purpose of this study was to assess the efficacy and safety of contrast-enhanced ultrasound performed with perflubutane microbubbles in comparison with unenhanced ultrasound and dynamic CT in the characterization of focal liver lesions during the vascular phase of imaging and in the detection of lesions during the Kupffer phase.SUBJECTS AND METHODS. A total of 196 patients were enrolled at 15 centers in Japan. Vascular phase images were obtained before contrast injection until 1 minute after injection. Kupffer phase images were obtained 10 minutes after injection. Dual-phase CT was performed as determined by standard clinical practice at each center. Unenhanced ultrasound, contrast-enhanced ultrasound, and CT images were read by blinded reviewers, and the results they reached regarding characterization and detection were compared with reference standard findings made by onsite investigators. The safety observation period was 72 hours after contrast administration.RESULTS. Among the 190 pati...