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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00829413
First received: January 26, 2009
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Liver Neoplasms
Drug: SonoVue®
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 Unenhanced Ultrasound Imaging Using Histology Or Combined Imaging/Clinical Data As Truth Standard

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • 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 ] [ 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 ]

Enrollment: 353
Study Start Date: June 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 7.5.1.2, 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)

  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: NCT00829413

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

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT00829413     History of Changes
Other Study ID Numbers: BR1-130
Study First Received: January 26, 2009
Last Updated: September 27, 2013
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 April 20, 2014