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Ultrasound Liver Intraoperative Imaging With SonoVue® (ULIIS)

Primary Purpose

Liver Metastases From Colorectal Primary Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Contrast-enhanced intraoperative ultrasound
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Metastases From Colorectal Primary Cancer focused on measuring Liver metastases, Colorectal primary cancer, Contrast-enhanced ultrasound, Sonovue®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Bergonié

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Contrast-enhanced intraoperative ultrasound

Arm Description

Contrast-enhanced intraoperative ultrasound

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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)

Full Information

First Posted
November 5, 2012
Last Updated
April 27, 2021
Sponsor
Institut Bergonié
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1. Study Identification

Unique Protocol Identification Number
NCT01880554
Brief Title
Ultrasound Liver Intraoperative Imaging With SonoVue®
Acronym
ULIIS
Official Title
Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases From Colorectal Primary Cancer
Keywords
Liver metastases, Colorectal primary cancer, Contrast-enhanced ultrasound, Sonovue®

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contrast-enhanced intraoperative ultrasound
Arm Type
Other
Arm Description
Contrast-enhanced intraoperative ultrasound
Intervention Type
Device
Intervention Name(s)
Contrast-enhanced intraoperative ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.
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.
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy
Description
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.
Time Frame
at time of surgery
Title
Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion
Description
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.
Time Frame
up to 3 months after surgery
Title
Description of Technical Arrangements for the CE-IOUS
Description
Description of technical arrangements for the CE-IOUS duration. The length of time during which contrast injection was useable.
Time Frame
At time of contrast-enhanced IOUS
Title
Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate
Description
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)
Time Frame
up to 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EVRARD Serge, PU-PH
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30879929
Citation
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.
Results Reference
derived
Links:
URL
https://www.e-cancer.fr/Professionnels-de-sante/Le-registre-des-essais-cliniques/Le-registre-des-essais-cliniques
Description
French national cancer institute (INCa) Clinical Trials Registry
URL
https://www.bergonie.fr/essais_cliniques/
Description
Website of the sponsor

Learn more about this trial

Ultrasound Liver Intraoperative Imaging With SonoVue®

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