Ultrasound Liver Intraoperative Imaging With SonoVue®
France68 participantsStarted 2011-06
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient with histological proven colorectal cancer.
✓. Operable liver metastases according to preoperative imagery. Operability is the possibility of treatment by resection and/or local destruction (radiofrequency, cryotherapy…).
✓. Patient treated or not with preoperative chemotherapy.
✓. With or without extra-hepatic metastases
✓. Age ≥ 18 years.
✓. Radiological assessment by CT and MRI liver and positron emission tomography scan (PETscan) within six weeks before surgery.
✓. Patient affiliated to the Social Security system.
✓. Signed informed consent.
Exclusion criteria
✕. Known hypersensitivity to sulfur hexafluoride or another component of SonoVue®.
✕. 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.
✕. Patients with right-to-left shunt, severe pulmonary arterial hypertension, uncontrolled systemic hypertension, as patients suffering from respiratory distress syndrome.
✕. Pregnant and lactating women.
What they're measuring
1
Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.
✕. Patients with contraindication for a CT scan, a MRI or a positron emission tomography (PET) with contrast.
✕. Patients with indication of two step liver surgery.
✕. Patients already included in the study.
✕. 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.