Early ultrasonography role by Contrast enhanced ultrasonography ( CEUS) evaluating therapy effectiveness in patients with hepatic metastasis of colorectal cancer treated with antiangiogenetic drug. - ND

Conditions: methastatic colorectal cancer
MedDRA version: 9.1Level: LLTClassification code 10061045Term: Colon neoplasm

Registration Number: EUCTR2007-001927-36-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Age > 18 years 2. Hystologicaly of colorectal adenocarcinoma 3. Not resectable hepatic metastasis 4. Diameter lesions > 5 millimeters ( at least one lesion) 5. Not preceding chemotherapy for metastatic disease. 6. Signed informed consent
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

A)Patients with contraindications to use of Sonovue 1. Recent Cardiac infarction and frequent and/or several angina cordis events or thoracic ache. 2. Recent surgery upon the coronary arteries 3. Recent electrocardiogram abnormalities 4. Frequent and/or several angina cordis events or thoracic ache in the latest week 5. Cardiac Failure ; severe arhythmia; cardiac right-to-left shunt 6. Serious pulmonary artery hypertension; not controlled arterial hypertension 7. Adult respiratory distress syndrome

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: assessment, by CEUS, of early response to antiangiogenic treatment in patients with liver mets from colorectal cancer treated by Bevacizumab plus Folfiri every 14 days (or by other protocols including 5FU and Irinotecan plus bevacizumab). Aim: Early assessment of the antiangiogenetic effectiveness of bevacizumab studied by CEUS vs RECIST criteria. The?target? lesions are only the ones measurable and the ones susceptible of reiterable measuring in CEUS. After US identification of a ?target? lesion the microcirculation of which will be evaluated by CEUS.;Secondary Objective: not declared in the protocol;Primary end point(s): Early assessment of the antiangiogenetic effectivenes of bevacizumab studied by CEUS vs RECIST criteria

Secondary Outcome Measures