Ultrasound Liver Intraoperative Imaging With SonoVue®

NCT01880554 | Completed Results DMC

• 1 other identifier: IB2010-29
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Metastases From Colorectal Primary Cancer

Keywords

Liver metastases; Colorectal primary cancer; Contrast-enhanced ultrasound; Sonovue®

Outcome Measures

Primary Outcomes (1)

• Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.

  The clinical utility will be evaluated in terms of justified modification of the surgical procedure following contrast-enhanced intra-operative ultrasound (CE-IOUS), compared to the surgical procedure following conventional intra-operative ultrasound. For each patient, we will consider CE-IOUS to be clinically useful: * if the surgical procedure envisaged at the end of the CE-IOUS is different from the surgical procedure envisaged at the end of the conventional ultrasound * and if the surgical procedure envisaged at the end of the CE-IOUS is justified We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS.

  At time of surgery

Secondary Outcomes (4)

• Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy

  at time of surgery

• Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion

  up to 3 months after surgery

• Description of Technical Arrangements for the CE-IOUS

  At time of contrast-enhanced IOUS

• Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate

  up to 3 months after surgery

Study Arms (1)

Contrast-enhanced intraoperative ultrasound

OTHER

Contrast-enhanced intraoperative ultrasound

Device: Contrast-enhanced intraoperative ultrasound

Interventions

Contrast-enhanced intraoperative ultrasound DEVICE

Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment: Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages

Contrast-enhanced intraoperative ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

Location

Related Publications (1)

• 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.

  PMID: 30879929 BACKGROUND

Results Point of Contact

• Title: Derek Dinart
• Organization: Institut Bergonie

d.dinart@bordeaux.unicancer.fr

Study Officials

• EVRARD Serge, PU-PH

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: June 19, 2013
• Study Start: June 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2017
• Last Updated: September 3, 2025
• Results First Posted: May 18, 2021

Record last verified: 2021-04

Locations

FR (1)