Colorectal CancerPhase 2OC-AP-ICG-IVNCT02032485
Near-Infrared Imaging of Peritoneal Carcinomatosis From Colorectal Cancer
A Phase 2 study testing Indocyanine Green in people with Colorectal Cancer and Peritoneal Carcinomatosis, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
The purpose of this study is to determine if Near-Infrared fluorescence imaging is an effective approach to detect the colorectal tumoral tissues and peritoneal implants in colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Peritoneal Carcinomatosis
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from histo-pathologically proven colorectal carcinoma who are candidate for "open" surgery,
- Informed consent form signed.
Who cannot join
- Age less than18 years old.
- Inability to give informed consent.
- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomy of the thyroid gland.
- Documented coronary disease.
- Advanced renal impairment (creatinine > 1,5mg/dl).
- During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
- Pregnancy, breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Colorectal Cancer
The purpose of this study is to determine if Near-Infrared fluorescence imaging is an effective approach to detect the colorectal tumoral tissues and peritoneal implants in colorectal cancer patients.
Read the detailed description
Primary objective
Evaluation of the ability of NIR imaging using ICG to demonstrate (the gross tumoral mass and/or) peritoneal metastatic " implants " in patients operated for peritoneal carcinomatosis from colorectal carcinoma
Secondary objective:
Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (and, if any is demonstrated per-operatively, a) in the nodes of these patients found fluorescent and removed and/or b) at the level of the fluorescent foci observed at the level of the hepatic surfaces)
Methodology:
The day before the operation:
ICG 0.125 mg/kg will be given as an iv injection the day before the operation.
In the operating room:
When the patient will be operated, the surgeons will (under "conventional" video control) search and establish as usual the presence (of "gross" tumoral mass and) of metastatic deposits at the level of the peritoneal surfaces. NIR imaging will be acquired during these manoeuvers and, if detected, fluorescent structures and/or foci will be anatomically defined by the surgeons.
If ("gross" tumoral mass and/or) metastatic deposits are seen fluorescent, the operation will be then continued as usual but each anatomical piece will be controlled "ex vivo" for its fluorescent character or not. All fluorescent foci on these anatomical pieces will be identified as such by a mark and/or by a "suture".
If ("gross" tumoral mass and/or) metastatic deposits are not seen fluorescent, ICG 0.125 mg/kg will be given as an iv injection and the vascularization, income of the ICG in the tumoral implants (judged by the surgeon the most representative of the patient's status) will be dynamically studied using the PDE camera during the 10 minutes following the IV injection.
If no hepatic metastases were pre-operatively documented, the surface of the liver will be controlled and, if superficial fluorescent foci are observed, these will be biopsied.
In the Laboratory of Pathology:
The tumoral tissues as well as -if identified- the "non identified as tumoral" fluorescent tissular foci will be processed as usual.
All the slides obtained will be analyzed using the near-infrared fluorescence microscope for the presence or the absence of (detectable) ICG and the different ICG-positive compartments (vascular spaces, interstitial spaces, normal and/or tumoral cells, macrophages,…) will be determined.
- Conditions
- Colorectal Cancer, Peritoneal Carcinomatosis
- Being tested
- Indocyanine Green
- Keywords
- colorectal cancer, Indocyanine Green, visualization of peritoneal metastases
- Medical subject headings
- Colorectal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG
An iv injection will be performed for the colorectal cancer patient before the operation.
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine Green | Experimental | Intravenous injection of 0.25 mg/kg Indocyanine Green in patients with peritoneal carcinomatosis from colorectal cancer before the surgery Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluorescence intensity of tumoral and healthy tissues after IV injection of ICG to patients with peritoneal carcinomatosis from colorectal origin.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Liberale, MD, Principal investigator, Surgeon in Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032485
- Sponsor's protocol ID
- 2013-000653-42
- Acronym
- OC-AP-ICG-IV
- Status last verified
- Jul 2014
- First submitted
- 20 Nov 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02032485
- Acronym / sponsor ID
- OC-AP-ICG-IV / 2013-000653-42
- Conditions
- Colorectal Cancer, Peritoneal Carcinomatosis
- Keywords
- colorectal cancer, Indocyanine Green, visualization of peritoneal metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Near-Infrared fluorescence imaging is an effective approach to detect the colorectal tumoral tissues and peritoneal implants in colorectal cancer patients.
Detailed description
Primary objective
Evaluation of the ability of NIR imaging using ICG to demonstrate (the gross tumoral mass and/or) peritoneal metastatic " implants " in patients operated for peritoneal carcinomatosis from colorectal carcinoma
Secondary objective:
Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (and, if any is demonstrated per-operatively, a) in the nodes of these patients found fluorescent and removed and/or b) at the level of the fluorescent foci observed at the level of the hepatic surfaces)
Methodology:
The day before the operation:
ICG 0.125 mg/kg will be given as an iv injection the day before the operation.
In the operating room:
When the patient will be operated, the surgeons will (under "conventional" video control) search and establish as usual the presence (of "gross" tumoral mass and) of metastatic deposits at the level of the peritoneal surfaces. NIR imaging will be acquired during these manoeuvers and, if detected, fluorescent structures and/or foci will be anatomically defined by the surgeons.
If ("gross" tumoral mass and/or) metastatic deposits are seen fluorescent, the operation will be then continued as usual but each anatomical piece will be controlled "ex vivo" for its fluorescent character or not. All fluorescent foci on these anatomical pieces will be identified as such by a mark and/or by a "suture".
If ("gross" tumoral mass and/or) metastatic deposits are not seen fluorescent, ICG 0.125 mg/kg will be given as an iv injection and the vascularization, income of the ICG in the tumoral implants (judged by the surgeon the most representative of the patient's status) will be dynamically studied using the PDE camera during the 10 minutes following the IV injection.
If no hepatic metastases were pre-operatively documented, the surface of the liver will be controlled and, if superficial fluorescent foci are observed, these will be biopsied.
In the Laboratory of Pathology:
The tumoral tissues as well as -if identified- the "non identified as tumoral" fluorescent tissular foci will be processed as usual.
All the slides obtained will be analyzed using the near-infrared fluorescence microscope for the presence or the absence of (detectable) ICG and the different ICG-positive compartments (vascular spaces, interstitial spaces, normal and/or tumoral cells, macrophages,…) will be determined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine Green | Experimental | Drug: Indocyanine GreenIntravenous injection of 0.25 mg/kg Indocyanine Green in patients with peritoneal carcinomatosis from colorectal cancer before the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from histo-pathologically proven colorectal carcinoma who are candidate for "open" surgery,
- Informed consent form signed.
Key exclusion criteria (8 listed)
- Age less than18 years old.
- Inability to give informed consent.
- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomy of the thyroid gland.
- Documented coronary disease.
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 |
|---|---|---|
| Indocyanine GreenAlso: ICGAn iv injection will be performed for the colorectal cancer patient before the operation. | Drug | Indocyanine Green |
Primary outcome
fluorescence intensity of tumoral and healthy tissues after IV injection of ICG to patients with peritoneal carcinomatosis from colorectal origin.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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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.
Gabriel Liberale, MD principal investigator
Surgeon in Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indocyanine Green in people with Colorectal Cancer and Peritoneal Carcinomatosis, run by Jules Bordet Institute at 1 site in Belgium.
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 2 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 15 Oct 2014. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
fluorescence intensity of tumoral and healthy tissues after IV injection of ICG to patients with peritoneal carcinomatosis from colorectal origin. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2014.