Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound Liver Intraoperative Imaging With SonoVue® (ULIIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880554
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

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).


Condition or disease Intervention/treatment Phase
Liver Metastases From Colorectal Primary Cancer Device: Contrast-enhanced intraoperative ultrasound Phase 2

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
Study Start Date : June 2011
Actual Primary Completion Date : September 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Contrast-enhanced intraoperative ultrasound
Contrast-enhanced intraoperative ultrasound
Device: Contrast-enhanced intraoperative ultrasound

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 Measures :
  1. The clinical utility will be evaluated in terms of the proposed amendment justified after ultrasound surgery of Intraoperative contrast, compared to the planned following surgery a conventional intraoperative ultrasonography [ Time Frame: at time of surgery ]

    For each patient, we will consider that CEUS intraoperative clinical utility:

    • if the planned surgery after contrast echocardiography is different from the intraoperative considered after surgery for conventional ultrasound,
    • if the planned surgery after contrast echocardiography Intraoperative warranted.


Secondary Outcome Measures :
  1. evaluation of the clinical utility of contrast echocardiography [ Time Frame: up to 3 months ]
    evaluation of the clinical utility of contrast echocardiography by subgroups depending on the pre-operative treatment and according to the response to treatment.

  2. Assessment of tumor perfusion quantification [ Time Frame: 1 year ]
    Assessment of tumor perfusion quantification by software specifically, in the general population and sub-groups according to the type preoperative treatment and depending on the response to treatment.

  3. Performance Evaluation of intraoperative ultrasound contrast per lesion [ Time Frame: follow up 3 months ]
    • Detection rate of liver metastases (equivalent to "Sensitivity injury"): number of true liver metastases detected by intraoperative ultrasound / contrast total real liver metastases. Upon discovery of a new lesion typically benign, no gesture will be made. The radiological monitoring at 3 months will confirm or not the presence and nature of the lesion.
    • Rate characterization of focal liver lesions: number of lesions whose nature was correctly defined by ultrasound Intraoperative contrast (benign and malignant) / total lesions detected by intraoperative ultrasound contrast.

  4. Description of technical arrangements for the CEUS Intraoperative and description of the specific toxicity of intraoperative use of SonoVue ®, [ Time Frame: 1 year ]
    • Description of technical arrangements for the CEUS intraoperative duration, number of injections and doses necessary time required between two injections, technical limitations.
    • Description de la toxicité spécifique de l'utilisation peropératoire de SonoVue®, selon l'échelle de toxicité NCI-CTC-AE version 4.

  5. Survival rate [ Time Frame: followed up to 5 years ]
    • overall survival, defined as the time from the date of surgery and date of death (regardless of cause).
    • progression-free survival, defined as the time from the date of surgery and the date of the first of the following events: progression (RECIST v1.1) or death (whatever the cause).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 TEPscan 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 TEP 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880554


Locations
Layout table for location information
France
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
Sponsors and Collaborators
Institut Bergonié
Investigators
Layout table for investigator information
Study Chair: EVRARD Serge, PU-PH Institut Bergonié

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01880554     History of Changes
Other Study ID Numbers: IB2010-29
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Keywords provided by Institut Bergonié:
Liver metastases
Colorectal primary cancer
Contrast-enhanced ultrasound
Sonovue®
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases