SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization

Exclusion Criteria

• •Has an acoustic window insufficient for adequate ultrasound examination of the liver.
• •Has a FLL that cannot be identified with unenhanced ultrasound.
• •Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion.
• •Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®.
• •Has previously been enrolled in and completed this study.
• •Known right to left cardiac shunt, bidirectional or transient.
• •Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®).
• •Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc.
• •Has received an investigational compound within 30 days before admission into this study.
• •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
• •Is determined by the Investigator that the subject is clinically unsuitable for the study.
• •Is a pregnant or lactating female. Exclude the possibility of pregnancy by:
• •testing on site at the institution serum βHCG within 24 hours prior to the start of SonoVue® administration, surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses.