Colon CarcinomaNCT04959604
Lymph Node Mapping Via Flourescent Dye in Colon Cancer
A study testing ICG-marking endoscopically in people with Colon Carcinoma and Lymph Node Metastases, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colon Carcinoma, Lymph Node Metastases
- What is being tested?
- ICG-marking endoscopically
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.
Who cannot join
- not wanting to participate
- other carcinoma then adenocarcinoma
- endoscopic marking not possible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University of Hamburg Medical Institutions
Hamburg
Julia-Kristin Grass, Dr., j.grass@uke.de
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Colon Carcinoma, Lymph Node Metastases
- Being tested
- ICG-marking endoscopically
- Keywords
- indocyanine green, lymphatic mapping, fluorescence
- Medical subject headings
- Colonic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-marking endoscopicallyProcedure or surgery
Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.
| Study group | Role | What they receive |
|---|---|---|
| ICG-marked Colon Carcinoma | Experimental | The participants will receive an endoscopic marking via ICG preoperatively Receives: Procedure: ICG-marking endoscopically |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Counting ICG-positive sites intraoperatively
Measured: intraoperative assessment
Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Counting ICG-positive sites video-analysis
Measured: 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
Measured: 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.
Measured: within one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start31 May 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention group. Participants will receive a state of the art surgical procedure with additional lymph node mapping
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Perez, Prof. Dr., Principal investigator, Dept of General Visceral and Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959604
- Sponsor's protocol ID
- CCLNM
- Status last verified
- May 2023
- First submitted
- 30 Jun 2021
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application
- ClinicalTrials.gov ID
- NCT04959604
- Acronym / sponsor ID
- CCLNM
- Conditions
- Colon Carcinoma, Lymph Node Metastases
- Keywords
- indocyanine green, lymphatic mapping, fluorescence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention group. Participants will receive a state of the art surgical procedure with additional lymph node mapping
| Arm | Type | Receives |
|---|---|---|
| ICG-marked Colon Carcinoma | Experimental | Procedure: ICG-marking endoscopicallyThe participants will receive an endoscopic marking via ICG preoperatively |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.
Key exclusion criteria (3 listed)
- not wanting to participate
- other carcinoma then adenocarcinoma
- endoscopic marking not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG-marking endoscopicallyPreoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green. | Procedure or surgery | ICG-marked Colon Carcinoma |
Primary outcome
Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Time frame: intraoperative assessment
Counting ICG-positive sites intraoperatively
Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Time frame: video-analysis within one week after surgery
Counting ICG-positive sites video-analysis
Number of ICG-positive lymph nodes after endoscopic marking of the tumour
Time frame: within one week after surgery
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
Time frame: within one week after surgery
ICG-positive sites outside standard resection area will be "cherry picked", sent to pathological examination separatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No. Available on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Perez, Prof. Dr. principal investigator
Dept of General Visceral and Thoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG-marking endoscopically in people with Colon Carcinoma and Lymph Node Metastases, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharina L Lucas, MD (+4915779600815, katharina.lucas@uni-wh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour (time frame: intraoperative assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.