Conditions: Liver Lesions
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 424
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy of Sonazoid™ and SonoVue® in participants with focal liver lesions (FLLs), by comparing pre-and post-contrast ultrasound examination findings with regard to various aspects of lesion diagnosis including diagnosis as benign versus malignant, specific lesion diagnosis, confidence in diagnosis, and quality of delineation of lesion-related blood vessels (from images obtained during vascular imaging) and detection of lesion presence and quality of delineation of the whole liver (from images obtained during whole liver imaging).

Detailed description:

Arms:
arm 1: Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight. arm 2: Participants will receive single I.V bolus injection of SonoVue® 2.4 milliliter (mL).

Interventions: intervention 1: Sonazoid™ intervention 2: SonoVue®
Intervention descriptions: intervention 1: Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection. intervention 2: Single Dose of SonoVue® 2.4 mL as I.V. injection.

Protocol document: