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Characterization of Focal Liver Lesions With SONOVUE®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Un-enhanced Ultrasound Imaging Using Histology or Combined Imaging/Clinical Data as Truth Standard


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Liver Neoplasms

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Trial Information

Characterization of Focal Liver Lesions With SONOVUE®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Un-enhanced Ultrasound Imaging Using Histology or Combined Imaging/Clinical Data as Truth Standard


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To demonstrate the Sensitivity and Specificity of SonoVue-enhanced US is superior to unenhanced US for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging clinical data as truth standard.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Maria Luigia Storto, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Bracco Diagnostics, Inc

Authority:

United States: Food and Drug Administration

Study ID:

BR1-128

NCT ID:

NCT00788697

Start Date:

September 2009

Completion Date:

March 2013

Related Keywords:

  • Liver Neoplasms
  • Neoplasms
  • Liver Neoplasms

Name

Location

Bracco Diagnostics IncPrinceton, New Jersey  08540