SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization
Condition: Liver Neoplasms
MeSH terms: Liver Neoplasms
Intervention: SonoVue®
Intervention description: SonoVue (2.4 mL)
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate the Sensitivity and Specificity of
      SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the
      characterization of benign versus malignant FLLs using final diagnosis based on histology or
      combined imaging (CE-CT and/or CE MRI)/clinical data as truth standard.
    

Eligibility criteria:

        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.