Clinical trial NCT00829413: SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Neoplasms
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

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 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.

Primary outcomes:
measure: Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard
timeFrame: 24 hours to 6 months
measure: Specificity: Percentage of True Negative Lesions Among All Benign Lesions Per Truth Standard'
timeFrame: 24 hours to 6 months
Secondary outcomes:
measure: Accuracy: Percentage of True Positive and True Negative Among All Lesions
timeFrame: 24 hours to 6 months
measure: Positive Predictive Value [PPV]: Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound
timeFrame: 24 hours to 6 months
measure: Negative Predictive Value [NPV]: Percentage of True Negative Lesions Among All Benign Lesions Per Ultrasound
timeFrame: 24 hours to 6 months
measure: Specific Diagnosis of Malignant FLLs
timeFrame: 24 hours to 6 months
measure: Specific Diagnosis of Benign FLLs
timeFrame: 24 hours to 6 months
measure: Inter-reader Agreement
timeFrame: 24 hours to 6 months
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics Inc.
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Alberto Spinazzi, M.D.
role: STUDY_DIRECTOR
References: