Lymph Node Mapping Via Flourescent Dye in Colon Cancer

Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application

The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative.

The draining lymph nodes will be visualized using the fluorescent dye indocyanine green.

The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative.

The draining lymph nodes will be visualized using the fluorescent dye indocyanine green.

Study Overview

• Status: Recruiting
• Conditions: Colon Carcinoma; Lymph Node Metastases
• Intervention / Treatment: Procedure: ICG-marking endoscopically

Detailed Description

Participants with a diagnosed (andeno)carcinoma of the ascending, transverse, descending and sigmoid colon will be included. Preoperatively the participants will receive an indocyanine green(ICG) injection at four points around the tumour endoscopically. The ICG marking will take place one to five days prior to surgery. In the draining lymph nodes of the specific region the ICG will accumulate and thus visible via fluorescence-camera during the surgery.

Intraoperatively, the precise locations of all fluorescent nodes will be documented photographically. A standard resection and lymph node dissection will be conducted, potential fluorescent nodes outside the standard resection lines will additionally be resected. The fresh specimen will then be measured, the fluorescent nodes marked and after the pathologic examination the nodes will be correlated to location, fluorescent yes/no and nodal positive/negative.

The aim ist not the visualization of the Sentinel node or the directly draining lymphatic vessel but all the nodes draining the peritumorous region at the point of surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katharina L Lucas, MD; Phone Number: +4915779600815; Email: katharina.lucas@uni-wh.de
• Study Contact Backup: Name: Julia-Kristin Grass, Dr.; Phone Number: +4915222815011; Email: j.grass@uke.de

Study Locations

• Germany
  • Hamburg, Germany
    • Recruiting
    • University of Hamburg Medical Institutions
    • Contact: Julia-Kristin Grass, Dr.; Email: j.grass@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.

Exclusion Criteria:

• not wanting to participate
• other carcinoma then adenocarcinoma
• endoscopic marking not possible

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICG-marked Colon Carcinoma; The participants will receive an endoscopic marking via ICG preoperatively	Procedure: ICG-marking endoscopically; Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour	Counting ICG-positive sites intraoperatively	intraoperative assessment
Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour	Counting ICG-positive sites video-analysis	video-analysis within one week after surgery
Number of ICG-positive lymph nodes after endoscopic marking of the tumour	Picking ICG-positive lymph nodes ex vivo in unfixed specimen, sending ICG positive nodes separately to pathological examination	within one week after surgery
Correlation of nodal-positive lymph nodes inside/outside the standard resection area	ICG-positive sites outside standard resection area will be "cherry picked", sent to pathological examination separatively.	within one week after surgery

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Daniel Perez, Prof. Dr., Dept of General Visceral and Thoracic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 30, 2026

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 10, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: indocyanine green; fluorescence; lymphatic mapping
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: CCLNM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Available on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No