Characterization of focal liver lesions with Sonovue(R)-enhancedultrasound imaging: a phase III, comparison in the same patient against unenhanced ultrasound imaging using histology or combinedimaging/clinical data as truth standard.

Conditions: At least one focal liver lesion requiring further work-up for complete characterization.
MedDRA version: 14.0Level: LLTClassification code 10024718Term: Liver tumor NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2010-022730-91-DE

Lead Sponsor: Bracco Imaging S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 246

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 lesion may include : 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
24h 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 48h prior to or from 24h to 30 days after the administration of Sonovue.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 246
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 antineoplasic 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 48h before and up
to 24h following the administration of Sonovue.
- Known right to left cardiac shunt, bidirectional or transient.
- Has any allergy to 1 or more ingredients of the investigational product.
- Has received an investigational compound within 30 days before
admission into this study
- Has any contraindication to 1 of the planned imaging procedures
(implants, claustrophobia, etc.)
- Has any medical condition or other circumstances which would
significantly decrease the chances of obtaining reliable data, achieving
this study objectives, or completing the study and/or post-dose followup examinations.
- Is a pregnant or lactating female.