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

Inclusion criteria

Participants may be included in the study if they meet all of the following criteria:

• Participant has at least 1 untreated focal liver lesions (FLL) but =<8 lesions (excluding cysts) <10 centimeter (cm) in diameter confirmed in a diagnostic examination performed in the past month (or past 3 months if lesion is benign) that can be visualised by non- contrast-enhanced (CE) ultrasound
• Participant has had a dynamic CE-computed tomography (CE-CT) or CE-magnetic resonance imaging (CE-MRI) examination within the past month or is scheduled to have one in the month following inclusion in the study and the original images (or copies thereof) are/will be available. (This inclusion criterion does not apply for participants enrolled as training cases. Investigators will be asked to submit standard of truth/ reference diagnosis for training cases whenever possible, since the cases may be used for training and testing the blinded readers prior to the blinded read)
• Participant is a 20- to 80-year-old inpatient or outpatient referred for an ultrasound examination of the liver
• Participant is able and willing to comply with study procedures and will give their signed and dated informed consent
• The participant, if female, is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, performed on the day of investigational medicinal product (IMP) administration (with the result known before IMP administration), are negative

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