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Keck Medical Center of USC
Characterization of Focal Liver Lesions with SonoVue-Enhanced Ultrasound Imaging: A Phase III, Intra-Patient Comparative Study versus Unenhanced Ultrasound Imaging Using Histology or Combined Imaging/Clinical Data as Truth Standard.
Closed to Accrual with Ongoing Follow-up
Defintions of terms and FAQ about clinical trials.
Edward Grant, M.D.
Other Trial Staff:
to see study documents.
You may participate in this study if:
Patient may be Male or female.
Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.
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®.
You may not participate in this study if:
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 ßHCG 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.
For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.