An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging
Condition: Liver Lesions
Intervention: Sonazoid™; SonoVue®
Intervention description: Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.; Single Dose of SonoVue® 2.4 mL as I.V. injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        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