SonoVue��-Enhanced Ultrasound Versus Unenhanced US for Focal Liver Lesion Characterization

Study ID	NCT00788697
Status	Recruiting
Phase	3
Source	ClinicalTrials.gov

Started	Sep 1 2009
Last Updated	Oct 13 2009
Estimated Completion	Oct 13 2009

About this clinical study

Summary

The purpose of this study is to demonstrate the superiority of SonoVue��-enhanced ultrasound versus unenhanced ultrasound for characterization of Focal Liver Lesions using final diagnosis based on histology or combined imaging/clinical data as truth standard.

Condition / Disease

Liver Neoplasms

Therapy

SonoVue��
Unenhanced Ultrasound(US)

Study Outcomes

To demonstrate the Sensitivity and Specificity of SonoVue-enhanced US is superior to unenhanced US for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging clinical data as truth standard.
To evaluate the accuracy and other performance parameters (positive predictive value [PPV], negative predictive value [NPV]) of SonoVue��-enhanced ultrasound for characterization of benign versus malignant FLLs in comparison to unenhanced ultrasound.
To evaluate the ability of SonoVue��-enhanced ultrasound to obtain a specific diagnosis of FLLs in comparison to unenhanced ultrasound.
To evaluate the inter-reader agreement in ultrasound images assessment (unenhanced and SonoVue��-enhanced separately).
To provide evidence of the safety and tolerability of intravenously administered SonoVue�� in subjects with focal liver disease.

Overview

Gender	male, female

Target Enrollment	156

Recruiting Healthy Volunteers	No

Locations

Bracco Diagnostics Inc

Princeton

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 ��HCG 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.

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