Skip to main content
OpenTrials
Completed

NCT Number: NCT01880554

Ultrasound Liver Intraoperative Imaging With SonoVue®

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contrast-enhanced intraoperative ultrasound

Device

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 outcomes

  1. Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.

    Time frame: At time of surgery

    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 outcomes

  1. Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy

    Time frame: at time of surgery

    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.

  2. Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion

    Time frame: up to 3 months after surgery

    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.

  3. Description of Technical Arrangements for the CE-IOUS

    Time frame: At time of contrast-enhanced IOUS

    Description of technical arrangements for the CE-IOUS duration. The length of time during which contrast injection was useable.

  4. Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate

    Time frame: up to 3 months after surgery

    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)

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

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

Acronym: ULIIS

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Jun 19, 2013
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.