QUANTITATIVE EVALUATION OF SONOVUE ENHANCED ULTRASONOGRAPHY FOR EARLY IDENTIFICATION OF SUBJECTS WITH HEPATOCELLULAR CARCINOMA REFRACTORY TO SORAFENIB THERAPY : A PHASE II EXPLORATIVE, INTRA-PATIENT COMPARATIVE STUDY VERSUS CONTRAST ENHANCED MDCT/MRI IMAGING - BR1-129

• Conditions: HCC epatocellular carcinoma; MedDRA version: 9.1Level: HLTClassification code 10025577

• Registration Number: EUCTR2008-008652-16-IT
• Lead Sponsor: BRACCO IMAGING

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Adult (age > or = 18 years) male or female; Providing written informed consent and willing to comply with protocol requirements; Confirmed diagnosis of advanced HCC either based on histology or based on AASDL criteria,as follows: -nodule < or = 1 cm in maximum diameter: histology. -nodule of 1-2 cm in diameter: two imaging procedures (CE-CT and CE-MRI or CE-US) showing coincidental typical vascular pattern for HCC (contrast uptake in the arterial phase and washout in venous or late phases). -nodule >2 cm in maximum diameter: one imaging procedure (CE-CT or CE-MRI or CE-US) showing typical vascular pattern for HCC (contrast uptake in the arterial phase and washout in venous or late phases). Candidate to start sorafenib as monotherapy. At least one liver lesion, measurable according to RECIST criteria1 and evaluable by CE-US defined as: -Acoustic window sufficient for adequate US examination of the liver (all target HCC borders should be correctly visualized by B-mode and lesions adjacent to diaphragmatic border should be avoided). -Not previously treated -Diameter of 2 cm or more -Perfused area &#8805; 50% of the total volume. At least 4 weeks since prior surgery/treatment with resolution of all acute toxic effects.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Has any clinically unstable cardiac condition prior to SonoVue&#61666; administration such as: -evolving or ongoing myocardial infarction, -a history of acute myocardial infarction or percutaneous coronary interventions (PCI) within the previous 3 months, -worsening of typical angina at rest within the previous 7 days, -significant worsening of cardiac symptoms within the previous 7 days, -recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings), -cardiac failure Class III/IV in accordance to the New York Heart Association , -severe cardiac rhythm disorders (ventricular tachycardia sustained and not sustained in combination with symptoms, flutter fibrillation, ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes). Has respiratory failure or a known history of pulmonary hypertension. Known allergy to one or more of the ingredients of the investigational product. Known allergy to iodinated contrast agents and MRI contrast agents. Any other contraindication to one of the imaging examinations (US, CT or MRI) e.g. implants, claustrophobia, inadequate medical conditions etc. Any contraindication to sorafenib 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. Subject clinically unsuitable for the study as per Investigators judgment. Pregnant and lactating women. A pregnancy test (serum &#946;HCG or urine stick) should be carried out within 24 hours prior to the administration of the investigational product to exclude pregnancy in women of child bearing potential.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified