An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging

Exclusion Criteria

• •The participant has an acute clinically fatal condition (i.e., not expected to survive for at least 6 months)
• •The participant has previously received Sonazoid™ or has received SonoVue® within the past 30 days
• •The participant has undergone or is undergoing systemic or loco-regional chemotherapy, or radiation therapy
• •The participant is participating in another clinical trial with an unregistered medicinal product, or less than 30 days have passed since completing participation in such a trial
• •The participant has a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension or shock)
• •The participant has known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue®
• •The participant has undergone or plans to undergo liver biopsy or surgery within the 24 hours before or after this examination
• •The participant has undergone or plans to undergo an examination with a contrast agent (i.e., iodinated x-ray contrast agent, magnetic resonance imaging (MRI) contrast agent or another ultrasound contrast agent) within the 24 hours before or after this examination
• •The participant is considered to be unsuitable to participate in the study by the investigator
• •The participant is known to have a right-to-left shunt, severe pulmonary hypertension (pulmonary artery pressure \>90 millimeter of mercury (mmHg) or uncontrolled systemic hypertension
• •The participant has a recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within the last 7 days, significant worsening of cardiac symptoms within the last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of electrocardiogram \[ECG\], laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders
• •The participant has adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
• •The participant has known thrombosis within the liver, portal, or mesenteric veins