Characterization of focal liver lesions with Sonovue(R)-enhancedultrasound imaging: a phase III, intrapatient comparative study versusunenhanced ultrasound imaging using histology or combinedimaging/clinical data as truth standard.

Bracco Imaging S.p.A.0 个研究点目标入组 246 人开始时间: 2011年6月21日最近更新: 2013年9月30日

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•- 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

•-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.

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