Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie. (SENSE)

February 15, 2016 updated by: Ismail Gögenür, Ismail Gögenur
This study is a clinical feasibility trial that will contribute to the clarification of whether sentinel node mapping with indocyanine green (ICG) provides a better basis for staging of colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients assigned for colon cancer will be operated as planned using laparoscopic techniques and the operation follows the normal procedure, in addition a sentinel node mapping is performed.

Indocyanine green is injected around the tumor by laparoscopic technique, the fluorescence is controlled and after 20 minutes the surgeon looks for sentinel nodes in a standardized manner. In the meantime, the surgeon proceeds with the operation as usual, except that the mesocolon can be resected only after sentinel node mapping has been performed.

After surgery the surgeon and the pathologist inspect the resected colon together and agree on D1, D2 and D3 margins. Any marked sentinel node(s) is verified and the location is checked on the colon diagram on the case report form. In addition, an ex vivo sentinel node mapping will be performed by the pathologist right after the surgery has ended. This is done to investigate if it is the same lymph nodes there will be identified by ex vivo as by intraoperative (in vivo) sentinel node mapping.

The lymph nodes in the resected colon and mesocolon are all analysed. Sentinel nodes and an equal number of randomly chosen non-sentinel nodes will be analysed further with additional sections and immune histochemistry.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital

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

Description

Inclusion Criteria:

  • Male and female patients above 18 years of age scheduled for laparoscopic colon cancer surgery in the department of Surgery, Herlev Hospital or Roskilde Hospital.

Exclusion Criteria:

  • iodine allergy
  • Poor kidney function (as it imply an increased risk of allergic reaction), estimated glomerular filtration rate should be above 40 ml/min.
  • Liver cirrhosis, Child-Pugh-score B and C [14]
  • Pregnancy and lactation
  • Previous anaphylactic reaction to a dye injection
  • Previous abdominal surgery

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sentinel node mapping
Sentinel node mapping with indocyanine green injected orally and anally to the tumor.
Procedure: Sentinel node mapping
Through transabdominal access via laparoscopic ports indocyanine green solution is injected around the tumor (25 mg indocyanine green dissolved in 9 ml sterile water and 1 ml 20% human albumin). This is done by the construction of two small boluses of 0.5 mL each into the colonic wall just orally and anally to the tumor margin, but not within the tumor itself. When the bolus is injected the fluorescence is controlled and after 20 minutes the surgeon looks for sentinel nodes in a standardized manner.
Other Names:
  • Karl Storz ICG system, to visualize the fluorescence
  • Indocyanine green, PULSION medical systems.
  • Single use aspiration needle, NA-220H-8025 from Olympus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of procedures with successful identification of sentinel nodes
Time Frame: day 1
Sentinel nodes is defined as the lymph node, first in line, draining from the cancer.
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of sentinel nodes identified during surgery and their localization
Time Frame: day 1
day 1
Number of sentinel nodes identified by ex vivo sentinel node mapping
Time Frame: week 1
week 1
Malignant status of the sentinel node(s)
Time Frame: week 1
week 1
Malignant status of the lymph nodes
Time Frame: week 1
week 1
Number of cases with negative sentinel node, but positive non-sentinel node
Time Frame: week 1
week 1
Localization of sentinel nodes with metastasis
Time Frame: week 1
week 1
Localization of lymph nodes with metastasis according to D1, D2 and D3 resection lines and if they are within 1 cm from a sentinel node
Time Frame: week 1
week 1
Number of cases where the sentinel node procedure has changed the clinical course of the patient
Time Frame: week 1
if staging and oncological treatment are changed because of the procedure
week 1
Number of procedures where the procedure is stopped due to technical reasons
Time Frame: day 1
day 1
Registration of possible side effects occurring due to the use of indocyanine green
Time Frame: day 1
day 1
Number of sentinel nodes identified by only one of the sentinel node mapping techniques
Time Frame: week 1
week 1
Total number of lymph nodes
Time Frame: week 1
week 1
Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines
Time Frame: week 1
week 1

Collaborators and Investigators

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

Sponsor

Ismail Gögenur

Investigators

  • Principal Investigator: Ismail Gögenur, Professor, Professor at University Hospital Køge

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

March 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENSE2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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