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

NCT ID: NCT00788697

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-07-31

Brief 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.

Detailed Description

Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.

Conditions

Liver Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients who received SonoVue

Patients with at least 1 target lesion requiring work-up for characterization to undergo

• Unenhanced ultrasound of the target lesion (UE-US): gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion using commercially available ultrasound equipment and standard techniques (B-mode or Harmonic imaging) to study the anatomy of the target lesion and surrounding parenchyma;
• SonoVue-enhanced ultrasound of the target lesion (CE-US): procedures described in protocol Section 7.5.1.2, to study the lesion vascularity in comparison to the surrounding parenchyma; and
• Truth standard

Group Type: OTHER

SonoVue-enhanced ultrasound

Intervention Type: DRUG

Contrast-enhanced ultrasound (CE-US) examination of the target lesion. Drug: SonoVue® Dose of 2.4 mL bolus injection administered intravenously. Maximum of 2 injections (4.8 mL)

Unenhanced ultrasound

Intervention Type: OTHER

-Unenhanced: Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion. Drug: None

Interventions

SonoVue-enhanced ultrasound

Contrast-enhanced ultrasound (CE-US) examination of the target lesion. Drug: SonoVue® Dose of 2.4 mL bolus injection administered intravenously. Maximum of 2 injections (4.8 mL)

Intervention Type: DRUG

Unenhanced ultrasound

-Unenhanced: Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion. Drug: None

Intervention Type: OTHER

Other Intervention Names

sulfur hexafluoride microbubbles

Eligibility 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 focal liver lesion (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 contrast-enhanced (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 beta-human chorionic gonadotropin (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Luigia Storto, M.D.

Role: STUDY_CHAIR

Bracco Diagnostics, Inc

Locations

Bracco Diagnostics Inc

Princeton, New Jersey, United States

Countries

United States

Other Identifiers

BR1-128

Identifier Type: -

Identifier Source: org_study_id