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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00829413
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : August 21, 2014
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Brief Summary:
The purpose of this study is to demonstrate the Sensitivity and Specificity of SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging (CE-CT and/or CE MRI)/clinical data as truth standard.

Condition or disease Intervention/treatment Phase
Liver Neoplasms Drug: SonoVue® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterization Of Focal Liver Lesions With Sonovue®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Unenhanced Ultrasound Imaging Using Histology Or Combined Imaging/Clinical Data As Truth Standard
Study Start Date : June 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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Arm Intervention/treatment
No Intervention: 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 (B-mode or Harmonic imaging) to study the anatomy of the target lesion and surrounding parenchyma.
Active Comparator: 2-Sonovue Enhanced
SonoVue®-enhanced ultrasound will be performed, according to the procedures described in Section, to study the lesion vascularity in comparison to the surrounding parenchyma. SonoVue® (2.4 mL) will be administered as a bolus injection in a peripheral vein.
Drug: SonoVue®
SonoVue (2.4 mL)

Primary Outcome Measures :
  1. To demonstrate the Sensitivity and Specificity of SonoVue®-enhanced US to that of 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the ability of SonoVue®-enhanced ultrasound to obtain a specific diagnosis of FLLs in comparison to unenhanced ultrasound. [ Time Frame: Day 0 ]
  3. To evaluate the inter-reader agreement in ultrasound images assessment (unenhanced and SonoVue®-enhanced separately). [ Time Frame: Day 0 ]
  4. To provide evidence of the safety and tolerability of intravenously administered SonoVue® in subjects with focal liver disease [ Time Frame: Day 0 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00829413

United States, New Jersey
Bracco Diagnostics Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Study Director: Alberto Spinazzi, M.D. Bracco Diagnostics, Inc

Responsible Party: Bracco Diagnostics, Inc Identifier: NCT00829413     History of Changes
Other Study ID Numbers: BR1-130
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases