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: August 19, 2014
Last verified: August 2014
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 220.127.116.11, 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||August 19, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases