Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01995591
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : January 12, 2016
Information provided by (Responsible Party):
Jules Bordet Institute

Brief Summary:
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.

Condition or disease
Colon Cancer Colon Surgery

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…)


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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Open-label Study Using ex Vivo Injection of ICG to Detect SLN in Patients With Colon Cancer
Study Start Date : January 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2015

Primary Outcome Measures :
  1. number of sentinel lymph nodes identified in pieces of colectomy from patients with colon cancer with Indocyanine Green [ Time Frame: 18 monthes ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with colon cancer who will have colectomy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01995591

Layout table for location information
Jules Bordet Institute
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Layout table for investigator information
Principal Investigator: Gabriel Liberale, MD Surgeon in Jules Bordet Institute
Layout table for additonal information
Responsible Party: Jules Bordet Institute Identifier: NCT01995591    
Other Study ID Numbers: 2068
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: June 2015
Keywords provided by Jules Bordet Institute:
colon cancer
sentinel lymph node
Indocyanine Green
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases