SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization
This study has been completed.
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
First received: January 26, 2009
Last updated: September 27, 2013
Last verified: September 2013
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.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||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
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
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 126.96.36.199, 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.
SonoVue (2.4 mL)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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®.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829413
|Bracco Diagnostics Inc.
|Princeton, New Jersey, United States, 08540 |
Bracco Diagnostics, Inc
||Alberto Spinazzi, M.D.
||Bracco Diagnostics, Inc
No publications provided
||Bracco Diagnostics, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 26, 2009
||September 27, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases