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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001927-36-IT
Enrollment
Unknown
Registered
2007-06-13
Start date
2007-04-23
Completion date
Unknown
Last updated
2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

methastatic colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10061045 Term: Colon neoplasm

Interventions

Trade Name: SONOVUE*1FL 8MCG+1SIR 5ML+ADAT Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Sulfur hexafluoride Concentration unit: mg milligram(s) Concentrati

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026