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Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.

Phase 2
18 Years
Open (Enrolling)
Liver Metastases From Colorectal Primary Cancer

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Trial Information

Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.

Hypothesis: Use of contrast ultrasound showed interesting results, which can increase
ultrasonography sensitivity performed during surgery in the evaluation of operable liver

This study is a two-stage phase II multicenter study (Simon's two-stage).

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,

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

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

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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

at time of surgery

Safety Issue:


Principal Investigator


Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié


France : Agence Française de Sécurité Sanitaire des Produits de Santé

Study ID:




Start Date:

June 2011

Completion Date:

December 2020

Related Keywords:

  • Liver Metastases From Colorectal Primary Cancer
  • Liver metastases
  • Colorectal primary cancer
  • Contrast-enhanced ultrasound
  • Sonovue®
  • Neoplasm Metastasis
  • Liver Neoplasms