Indocyanine Green (ICG) in the ex Vivo Detection of Sentinel Lymph Node (SLN)in Colon Cancer (2068)

January 11, 2016 updated by: Jules Bordet Institute

Prospective Open-label Study Using ex Vivo Injection of ICG to Detect SLN in Patients With Colon Cancer

Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine Green injections around the tumour in pieces of colectomy from patients with colon cancer.

Study Overview

Status

Completed

Conditions

Detailed Description

Primary objective Feasibility study of ex vivo injections of ICG to image and detect the sentinel lymph nodes in patients with colon cancer.

Secondary objectives:

To determine the sensitivity of ICG in the dissected piece of colon cancer compared with the blue dye.

Tertiary objectives:

Evaluation of the influence of this approach on the up-staging of the patients

Microscopic study of the ICG distribution in the lymph nodes (in the lymphatic sinuses, in specific cells, in cancerous foci…)

Methodology:

In the operating room:

Patients will undergo standard surgical resection. Immediately after removal of the colon and node-bearing mesentery, using different 29 Gauge insulin syringes, blue dye (2 ml blue dye: 0.5 ml per injection) and ICG (2 ml with 0,5 mg ICG per ml: 0.5 ml per injection) will be injected in the fresh specimen beside each other submucosally around the tumour in at least four sites (as many injections needed to cover all the perimeter of the tumour) for each agent. The injection sites will be then gently stretched and massaged for 3-5 min to stimulate the tracers to flow along the lymphatic channels. Fluoroscopic imagings of the mesentery will be performed during the injections and during these manoeuvers.

The research and identification of the sentinel lymph nodes will be then performed as follows:

  1. he will first localize the blue colored lymph vessels (if visible) as well as the palpable and/or blue colored lymph nodes. These last ones will be marked for dissection with a blue suture.
  2. using the PDE camera, he will thereafter localize the fluorescent lymph vessels (if visible) as well as the palpable and/or fluorescent lymph nodes. These last ones will be marked for dissection with a green suture.

Histopathology in the Laboratory of Pathology:

When all SLN are identified, they will be dissected and classified as follows:

  • SLN first seen as blue and confirmed also as fluorescent using PDE
  • SLN seen as blue but not confirmed to be fluorescent using PDE
  • SLN not directly visible as blue but seen fluorescent using PDE (the LN in this group will be controlled for their blue or not character when dissected)
  • LN identified by the pathologist as pathological but not blue and not fluorescent.

After the dissection of these SLN, the specimen will be processed as usual using routine procedure for further examination of the non SLN by the pathologists. Once these lymph nodes are dissected, they will be tested for the emitted fluorescence.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Jules Bordet Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with colon cancer who will have colectomy

Description

Inclusion Criteria:

  • Patients with histo-pathological diagnosis of colon cancer who are candidate for laparoscopic colectomy,
  • Informed consent form signed.

Exclusion Criteria:

  • Definite lymph node metastases diagnosed either pre-operatively, or per-operatively
  • Inability to give informed consent,
  • Age < 18 years old,
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of sentinel lymph nodes identified in pieces of colectomy from patients with colon cancer with Indocyanine Green
Time Frame: 18 monthes
18 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Investigators

  • Principal Investigator: Gabriel Liberale, MD, Surgeon in Jules Bordet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

November 25, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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