Clinical trial · Interventional
Ultrasound Liver Intraoperative Imaging With SonoVue®
Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
NCT01880554CI-TRIAL-00094461ULIIScompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases From Colorectal Primary Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhanced intraoperative ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Contrast-enhanced intraoperative ultrasound
- description
- Contrast-enhanced intraoperative ultrasound
- interventionNames
- Device: Contrast-enhanced intraoperative ultrasound
Primary outcomes (1)
- measure
- Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.
- timeFrame
- At time of surgery
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDDesolneux 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