Characterization of Focal Liver Lesions With SONOVUE®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Un-enhanced Ultrasound Imaging Using Histology or Combined Imaging/Clinical Data as Truth Standard
- Provides written Informed Consent and is willing to comply with protocol
- 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®.
- 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
- 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
- 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.