Liver Metastases From Colorectal Primary CancerULIISNCT01880554

Ultrasound Liver Intraoperative Imaging With SonoVue®

A study testing Contrast-enhanced intraoperative ultrasound in people with Liver Metastases From Colorectal Primary Cancer, run by Institut Bergonié at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Metastases From Colorectal Primary Cancer
What is being tested?: Contrast-enhanced intraoperative ultrasound
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteFrance
Study dates: Jun 2011to Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Institut Bergonié
Bordeaux, Aquitaine, 33000

Other trials in France

About this study

Official title: 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 metastases.

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

Read the 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).

Conditions: Liver Metastases From Colorectal Primary Cancer
Being tested: Contrast-enhanced intraoperative ultrasound
Keywords: Liver metastases, Colorectal primary cancer, Contrast-enhanced ultrasound, Sonovue®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Contrast-enhanced intraoperative ultrasoundDevice
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

Study groups in NCT01880554
Study group	Role	What they receive
Contrast-enhanced intraoperative ultrasound	Other	Contrast-enhanced intraoperative ultrasound Receives: Device: Contrast-enhanced intraoperative ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At time of surgery

Secondary outcomes (4)

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.
Measured: at time of surgery
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.
Measured: up to 3 months after surgery
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.
Measured: At time of contrast-enhanced IOUS
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)
Measured: up to 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jun 2017

First posted19 Jun 2013 (estimated)
Study startJun 2011
Primary completionSep 2016
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Liver Metastases From Colorectal Primary CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01880554
Sponsor's protocol ID: IB2010-29
Acronym: ULIIS
Status last verified: Apr 2021
First submitted: 5 Nov 2012
Last updated: 3 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30879929

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
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RecruitingObservational study
PrOspEctive Metastases Imaging (POEM)
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RecruitingPhase 2
Hepatic Arterial Infusion Chemotherapy in Patients With Inoperable Colorectal Cancer Liver Metastasis
Colorectal Adenocarcinoma Metastatic in the Liver, Liver Metastasis Colon Cancer

All Liver Metastases From Colorectal Primary Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
ClinicalTrials.gov ID: NCT01880554
Acronym / sponsor ID: ULIIS / IB2010-29
Conditions: Liver Metastases From Colorectal Primary Cancer
Keywords: Liver metastases, Colorectal primary cancer, Contrast-enhanced ultrasound, Sonovue®
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Institut BergoniéUniversity, hospital or other
Study start: Jun 2011
Primary completion: Sep 2016 (actual)
Study completion: Jun 2017 (actual)
First posted: 19 Jun 2013 (estimated)
Results: Posted 18 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Contrast-enhanced intraoperative ultrasound	Other	Device: Contrast-enhanced intraoperative ultrasoundContrast-enhanced intraoperative ultrasound

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Contrast-enhanced intraoperative ultrasoundOnce 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	Device	Contrast-enhanced intraoperative ultrasound

Primary outcome

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.

4 secondary outcomes

Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy
Time frame: at time of surgery
Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion
Time frame: up to 3 months after surgery
Description of Technical Arrangements for the CE-IOUS
Time frame: At time of contrast-enhanced IOUS
Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate
Time frame: up to 3 months after surgery

Results and safety

Results posted to the registry on 18 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Contrast-enhanced Intraoperative Ultrasound	68	52

Primary outcome: Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.

Time frame: At time of surgery. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Contrast-enhanced Intraoperative Ultrasound n = 52
Value	7.7 (3.2 to 18.6)

Population analysed: We used a 2-stage Simon's design with the following assumptions: * maximum tolerated futility rate: 5%, * expected minimum utility rate: 15%, * Type I error of 10%, * power of 85%. Thus, 52 eligible and evaluable patients were required (25 in the first stage). First stage: stop, if CE-IOUS is not deemed clinically useful for at least one patient (4.0%). Second stage: CE-IOUS clinically useful if the planned surgical procedure is modified and justified for 5 or more patients (9.6%).

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Contrast-enhanced Intraoperative Ultrasound	11 of 54 (20.4%)	2 of 54 (3.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30879929Desolneux 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.

Related trials for Liver Metastases From Colorectal Primary Cancer

Active, not recruiting
Surgical Margin Assessment Using Intra-operative High-resolution PET/CT in Patients With Cancers Referred to Surgical Resection, an Exploratory Pilot Study
Breast Cancer, Head and Neck Cancers
Not yet recruitingPhase 2
Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases
Liver Metastases, Non-Small Cell Lung Cancer
Active, not recruiting
Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
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RecruitingObservational study
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

EVRARD Serge, PU-PH study chair

Institut Bergonié

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Contrast-enhanced intraoperative ultrasound in people with Liver Metastases From Colorectal Primary Cancer, run by Institut Bergonié at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases. (time frame: At time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01880554, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.