Ultrasound Liver Intraoperative Imaging With SonoVue®

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01880554
• Date of registration: 05/11/2012
• Prospective Registration: No
• Primary sponsor: Institut Bergonié
• Public title: Ultrasound Liver Intraoperative Imaging With SonoVue® ULIIS
• Scientific title: Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
• Date of first enrolment: June 2011
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01880554
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: EVRARD Serge, PU-PH
• Affiliation: Institut Bergonié

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Liver Metastases From Colorectal Primary Cancer

Intervention(s)

Device: Contrast-enhanced intraoperative ultrasound

Primary Outcome(s)

The clinical utility will be evaluated in terms of the proposed amendment justified after ultrasound surgery of Intraoperative contrast, compared to the planned following surgery a conventional intraoperative ultrasonography [Time Frame: at time of surgery]

Secondary Outcome(s)

evaluation of the clinical utility of contrast echocardiography [Time Frame: up to 3 months]

Performance Evaluation of intraoperative ultrasound contrast per lesion [Time Frame: follow up 3 months]

Description of technical arrangements for the CEUS Intraoperative and description of the specific toxicity of intraoperative use of SonoVue ®, [Time Frame: 1 year]

Assessment of tumor perfusion quantification [Time Frame: 1 year]

Survival rate [Time Frame: followed up to 5 years]

Secondary ID(s)

IB2010-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors