Ultrasound Liver Intraoperative Imaging With SonoVue®
Conditions
Liver Metastases From Colorectal Primary Cancer
Conditions: official terms
Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Liver metastases, Colorectal primary cancer, Contrast-enhanced ultrasound, Sonovue®
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Contrast-enhanced intraoperative ultrasound
Type: Device
Overall Status
Recruiting
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).
Detailed 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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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 TEPscan 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 TEP 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.
Location
Institut Bergonié
Bordeaux, Aquitaine, France
Status: Recruiting
Contact: EVRARD SERGE, PU-PH - s.evrard@bordeaux.unicancer.fr
Start Date
June 2011
Completion Date
December 2020
Sponsors
Institut Bergonié
Source
Institut Bergonié
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page