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Lymph Node Mapping Via Flourescent Dye in Colon Cancer

Primary Purpose

Colon Carcinoma, Lymph Node Metastases

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ICG-marking endoscopically
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Carcinoma focused on measuring indocyanine green, lymphatic mapping, fluorescence

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Hamburg Medical InstitutionsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG-marked Colon Carcinoma

Arm Description

The participants will receive an endoscopic marking via ICG preoperatively

Outcomes

Primary Outcome Measures

Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Counting ICG-positive sites intraoperatively
Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Counting ICG-positive sites video-analysis
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
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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2021
Last Updated
May 21, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT04959604
Brief Title
Lymph Node Mapping Via Flourescent Dye in Colon Cancer
Official Title
Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Carcinoma, Lymph Node Metastases
Keywords
indocyanine green, lymphatic mapping, fluorescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention group. Participants will receive a state of the art surgical procedure with additional lymph node mapping
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICG-marked Colon Carcinoma
Arm Type
Experimental
Arm Description
The participants will receive an endoscopic marking via ICG preoperatively
Intervention Type
Procedure
Intervention Name(s)
ICG-marking endoscopically
Intervention Description
Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.
Primary Outcome Measure Information:
Title
Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Description
Counting ICG-positive sites intraoperatively
Time Frame
intraoperative assessment
Title
Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Description
Counting ICG-positive sites video-analysis
Time Frame
video-analysis within one week after surgery
Title
Number of ICG-positive lymph nodes after endoscopic marking of the tumour
Description
Picking ICG-positive lymph nodes ex vivo in unfixed specimen, sending ICG positive nodes separately to pathological examination
Time Frame
within one week after surgery
Title
Correlation of nodal-positive lymph nodes inside/outside the standard resection area
Description
ICG-positive sites outside standard resection area will be "cherry picked", sent to pathological examination separatively.
Time Frame
within one week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina L Lucas, MD
Phone
+4915779600815
Email
katharina.lucas@uni-wh.de
First Name & Middle Initial & Last Name or Official Title & Degree
Julia-Kristin Grass, Dr.
Phone
+4915222815011
Email
j.grass@uke.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Perez, Prof. Dr.
Organizational Affiliation
Dept of General Visceral and Thoracic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hamburg Medical Institutions
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia-Kristin Grass, Dr.
Email
j.grass@uke.de

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Available on reasonable request

Learn more about this trial

Lymph Node Mapping Via Flourescent Dye in Colon Cancer

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