Ultrasound Liver Intraoperative Imaging With SonoVue®

Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.

Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.

This study is a two-stage phase II multicenter study (Simon's two-stage).

Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.

This study is a two-stage phase II multicenter study (Simon's two-stage).

Inclusion Criteria:

1. Patient with histological proven colorectal cancer.
2. Operable liver metastases according to preoperative imagery. Operability is the possibility of treatment by resection and/or local destruction (radiofrequency, cryotherapy…).
3. Patient treated or not with preoperative chemotherapy.
4. With or without extra-hepatic metastases
5. Age ≥ 18 years.
6. Radiological assessment by CT and MRI liver and positron emission tomography scan (PETscan) within six weeks before surgery.
7. Patient affiliated to the Social Security system.
8. Signed informed consent.

Exclusion Criteria:

1. Known hypersensitivity to sulfur hexafluoride or another component of SonoVue®.
2. Patients with recent acute coronary syndrome or suffering from unstable ischemic heart disease, especially: evolving myocardial infarction, unstable angina during the last 7 days, recent coronary intervention or another factor suggesting clinical instability, acute heart failure, class III or IV heart failure, severe arrhythmias.
3. Patients with right-to-left shunt, severe pulmonary arterial hypertension, uncontrolled systemic hypertension, as patients suffering from respiratory distress syndrome.
4. Pregnant and lactating women.
5. Patients with contraindication for a CT scan, a MRI or a positron emission tomography (PET) with contrast.
6. Patients with indication of two step liver surgery.
7. Patients already included in the study.
8. Patient who couldn't be treated or followed up according to study criteria for psychological, social, family or geographical reasons. Patient deprived of liberty or under guardianship.