N/A
N=68
Ultrasound Liver Intraoperative Imaging With SonoVue®
Liver Metastases From Colorectal Primary Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01880554 ↗Enrolled (actual)
68
Serious AEs
20.4%
Results posted
May 2021
Primary outcome: Primary: Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases. — 7.7 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contrast-enhanced intraoperative ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Bergonié
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases. |
7.7 | — |
| SECONDARY Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy |
7.31 | — |
| SECONDARY Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion |
0.75 | — |
| SECONDARY Description of Technical Arrangements for the CE-IOUS |
225 | — |
| SECONDARY Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate |
0.94 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01880554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.