At least one focal liver lesion requiring further work-up for complete characterization. MedDRA version: 14.0 Level: LLT Classification code 10024718 Term: Liver tumor NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SonoVue
Pharmaceutical Form: Powder and solvent for suspension for injection
CAS Number: 2551-62-4
Current Sponsor code: SonoVue
Other descriptive name: SULFUR HEXAFLUORIDE
Concentration u
Sponsors
Bracco Imaging S.p.A.
Eligibility
Sex/Gender
All
Inclusion 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 lesion may include : 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 24h 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 48h prior to or from 24h to 30 days after the administration of Sonovue. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 246 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 antineoplasic 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 48h before and up to 24h following the administration of Sonovue. - Known right to left cardiac shunt, bidirectional or transient. - Has any allergy to 1 or more ingredients of the investigational product. - Has received an investigational compound within 30 days before admission into this study - Has any contraindication to 1 of the planned imaging procedures (implants, claustrophobia, etc.) - Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving this study objectives, or completing the study and/or post-dose followup examinations. - Is a pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the sensitivity and specificity of Sonovue-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant focal liver lesions (FLLs) using final diagnosis based on histology or combiend imaging (CE-CT and/or CE-MRI)/clinical data as truth standard.;Secondary Objective: 1. to evaluate the accuracy and other performance parameters (positive predictive value, negative predictive value of Sonovue-enhanced ultrasound for characterization of benign versus malignant- FLLs in comparison to unenhanced ultrasound 2. to evaluate the ability of Sonovue-enhanced ultrasound to obtain a specific diagnosis of FLLs in comparison to unenhanced ultrasound. 3. to evaluate the inter-reader agreement in ultrasound images assessment (unenhanced and Sonovue-enhanced separately) 4. to provide evidence of the safety and tolerability of intravenously administered Sonovue in subjects with focal liver disease.;Primary end point(s): The sensitivity of Sonovue-enhanced ultrasound is superior as compared to unenhanced ultrasound for at least 2 of the 3 off-site assessors analyzing their data separately.;Timepoint(s) of evaluation of this end point: After clinical evaluation by 3 off-site assessors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The specificity of Sonovue-enhanced ultrasound is superior as compared to unenhanced ultrasound for at least 2 of the 3 off-site assessors analyzing their data separately.;Timepoint(s) of evaluation of this end point: After clinical evaluation by 3 off-site assessors. | — |
Countries
Canada, France, Germany, United States
Contacts
Public ContactAlessandra D'Aponte
Bracco Imaging S.p.A.
Outcome results
None listed