Liver Metastases From Colorectal Primary Cancer Clinical Trial
— ULIISOfficial title:
Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
| NCT number | NCT01880554 |
| Other study ID # | IB2010-29 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2011 |
| Est. completion date | June 2017 |
| Verified date | April 2021 |
| Source | Institut Bergonié |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | June 2017 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Bergonié | Bordeaux | Aquitaine |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Bergonié |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy | The primary endpoint will be assessed in the subgroup of patients who received preoperative chemotherapy. As for the primary outcome, the clinical utility is evaluated in terms of justified modification of the surgical gesture envisaged following CE-IOUS, compared to the surgical gesture envisaged following a conventional intraoperative ultrasound.
We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS in the subgroup of patients who received preoperative chemotherapy. |
at time of surgery | |
| Secondary | Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion | Detection of malignant lesions by CE-IOUS in chemotherapy-free patients within 3 post-operative months. The detection rate is defined as the proportion of malignant lesions for which there is concordance between the diagnosis established by CE-IOUS and the reference examination. | up to 3 months after surgery | |
| Secondary | Description of Technical Arrangements for the CE-IOUS | Description of technical arrangements for the CE-IOUS duration. The length of time during which contrast injection was useable. | At time of contrast-enhanced IOUS | |
| Secondary | Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate | Characterisation rate for focal liver lesions: the proportion of lesions whose nature on CE-IOUS is identical to the nature of the lesions defined by the reference examinations among all the lesions seen on CE-IOUS (malignant and benign) | up to 3 months after surgery |