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

Inclusion Criteria:

   - Male/female.

   - Provides written Informed Consent and is willing to comply with protocol requirements.

   - Is at least 18 years of age.

   - Has at least 1 FLL (target lesion) requiring work-up for characterization. Target
   lesions may include those:

Incidentally detected, In subjects with chronic hepatitis or liver cirrhosis, In subjects
with known history of malignancy.

   - Is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30
   days after the SonoVue® administration OR

   - In case tissue biopsy is not indicated nor surgery planned, is scheduled for or has
   performed a CE-CT and/or CE-MRI of the target lesion from 30 days to 48 hours prior to
   or from 24 hours to 30 days after the administration of SonoVue®.

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.