Ultrasound Liver Intraoperative Imaging With SonoVue® (ULIIS)

Institut Bergonié

Status

Completed

Conditions

Liver Metastases From Colorectal Primary Cancer

Treatments

Device: Contrast-enhanced intraoperative ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT01880554

IB2010-29

Details and patient eligibility

About

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).

Full description

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).

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
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.