Clinical trial NCT01880554: Ultrasound Liver Intraoperative Imaging With SonoVue®
Official title: Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Metastases From Colorectal Primary Cancer
Keywords: Liver metastases
Colorectal primary cancer
Contrast-enhanced ultrasound
Sonovue®
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

Eligibility 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 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.

Primary outcomes:
measure: Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.
timeFrame: At time of surgery
Secondary outcomes:
measure: Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy
timeFrame: at time of surgery
measure: Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion
timeFrame: up to 3 months after surgery
measure: Description of Technical Arrangements for the CE-IOUS
timeFrame: At time of contrast-enhanced IOUS
measure: Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate
timeFrame: up to 3 months after surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
Study officials:
affiliation: Institut Bergonié
name: EVRARD Serge, PU-PH
role: STUDY_CHAIR
References:
citation: Desolneux G, Isambert M, Mathoulin-Pelissier S, Dupre A, Rivoire M, Cattena V, Palussiere J, Dinart D, Bellera C, Evrard S. Contrast-enhanced intra-operative ultrasound as a clinical decision making tool during surgery for colorectal liver metastases: The ULIIS study. Eur J Surg Oncol. 2019 Jul;45(7):1212-1218. doi: 10.1016/j.ejso.2019.03.002. Epub 2019 Mar 10.