Clinical Research Directory

Inclusion Criteria: * The subject is \<18 years of age on the day of consent. * The subject has at least 1 untreated FLL with ≤8 lesions (excluding cysts), with ≤8 cm confirmed in a diagnostic examination performed in the past month (or past 3 months if the lesion was benign) and that could also be visualised when obtained via unenhanced ultrasound imaging * The subject has had a dynamic CECT or CEMRI examination within the past month or is scheduled to have one in the month following inclusion in the study, and these images are/would be available. * The subject can comply with study procedures. * Parents or legally authorised representatives have signed the Informed Consent Form approved for this study by the Independent Review Board (IRB)/Independent Ethics Committee (IEC). The form will indicate that the patient (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. Patients who are able to provide assent have signed an age-appropriate paediatric assent form * Post-menarcheal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day. * Post-menarcheal female patients and male patients who are sexually active with a partner of childbearing potential must be practicing abstinence or be using an effective form of birth control (See Section 8.6) for ≥30 days before being enrolled in the study * The subject has a body weight of 3 kg or greater. * The subject has a negative egg allergy test if the egg allergy status of the subject is unknown. Exclusion Criteria: * The subject has a known or suspected hypersensitivity to any of the components of Sonazoid™, including 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 subject has an acute clinically fatal condition (i.e., the expected survival is ≤6 months). * The subject has previously received Sonazoid™ or another ultrasound contrast agent within the past 30 days. * The subject had undergone or is planning to undergo an examination with a contrast agent (i.e., iodinated x-ray contrast agent, MRI contrast agent or another ultrasound contrast agent) within the 24 hours before or after Sonazoid™ injection. * The subject has undergone or was undergoing systemic or loco-regional chemotherapy or radiation therapy * The subject is participating in another clinical trial with an unregistered medicinal product, or less than 30 days has passed since the subject completed participation in such a trial * The subject is a pregnant or lactating female. * The physician judges that a large-enough needle (24-gauge or larger) cannot be inserted. * The subject has a known right-left cardiac shunt.