Patients affected by advanced colorectal carcinoma MedDRA version: 9.1 Level: SOC Classification code 10017947
Conditions
Interventions
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: SonoVue
Concentration unit: µl microlitre(s)
Concentration type: equal
Concentration number: 8-
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent previously obtained in associated protocol • Enrolment in associated protocol; • Metastatic colorectal cancer with liver envolvment patients enrolled in associated trial; • Written informed consent for CEUS study. 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: • Contraindication to CEUS. SonoVue is controindicated in patients with recent acute coronary syndrome or clinical unstable ischaemic cardiac disease;in patients known to have right-to-left shunts,severe pulmonary hypertension (>90 mmhg),and in patients with adult respiratory distress syndrome; • Concomitant treatment with Cetuximab; • Previous surgical resection, termoablation, chemoembolization of liver metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate changes in tumor perfusion of liver metastases from colorectal cancer. The two principal purposes of this study are: - Study changes decribed above after first or second line treatment conteining Bevacizumab (cases) and to compare obtained data with the same evaluation after chemotherapy alone (controls). - Correlate the early antiangiogenic effect to the clinical outcome of the patient (tumor response, progression free survival).;Secondary Objective: ;Primary end point(s): The objective of this study is to evaluate changes in tumor perfusion of liver metastases from colorectal cancer in patients enrolled in the ITACa protocol. The two principal purposes of this study are: - Study changes decribed above after first or second line treatment conteining Bevacizumab (cases) and to compare obtained data with the same evaluation after chemotherapy alone (controls). - Correlate the early antiangiogenic effect to the clinical outcome of the patient (tumor response, progression free survival). | — |
Countries
Italy
Outcome results
None listed