SonoVue®-Enhanced Ultrasound Versus Unenhanced US for Focal Liver Lesion Characterization - Full Text View

Purpose

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	Intervention	Phase
Liver Neoplasms	Drug: SonoVue® Procedure: Unenhanced Ultrasound(US)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Characterization of Focal Liver Lesions With SONOVUE®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Un-enhanced Ultrasound Imaging Using Histology or Combined Imaging/Clinical Data as Truth Standard

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
To evaluate the ability of SonoVue®-enhanced ultrasound to obtain a specific diagnosis of FLLs in comparison to unenhanced ultrasound. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
To evaluate the inter-reader agreement in ultrasound images assessment (unenhanced and SonoVue®-enhanced separately). [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
To provide evidence of the safety and tolerability of intravenously administered SonoVue® in subjects with focal liver disease. [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	246
Study Start Date:	September 2009
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1-Unenhanced Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion will be performed using commercially available ultrasound equipment and standard techniques to study the anatomy of the target lesion and surrounding parenchyma.	Procedure: Unenhanced Ultrasound(US) Gray scale and Doppler (color or power imaging) ultrasound
Active Comparator: 2-Sonovue Enhanced SonoVue-enhanced ultrasound will be performed, according to the procedures described in the protocol, to study the lesion vascularity in comparison to the surrounding parenchyma.	Drug: SonoVue® SonoVue® (2.4 mL)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788697

Locations

United States, New Jersey
Bracco Diagnostics Inc
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

Study Chair:

Maria Luigia Storto, M.D.

Bracco Diagnostics, Inc

More Information

No publications provided

Responsible Party:	Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:	NCT00788697 History of Changes
Other Study ID Numbers:	BR1-128
Study First Received:	November 7, 2008
Last Updated:	October 16, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Liver Neoplasms
Digestive System Neoplasms

Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 19, 2013