Colon CancerSENSENCT02167087
Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie.
A study testing Sentinel node mapping in people with Colon Cancer and Lymphatic Metastasis, run by Ismail Gögenür at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Lymphatic Metastasis
- What is being tested?
- Sentinel node mapping
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Colon Cancer, Lymphatic Metastasis
- Being tested
- Sentinel node mapping
- Keywords
- Sentinel node mapping, lymphatic mapping, lymphatic metastasis, Aberrant lymphatic drainage, indocyanine green, ICG, near infrared, colon cancer, laparoscopic surgery
- 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.
Sentinel node mappingProcedure or surgery
Also called Karl Storz ICG system, to visualize the fluorescence, Indocyanine green, PULSION medical systems., Single use aspiration needle, NA-220H-8025 from Olympus.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel node mapping | Experimental | Sentinel node mapping with indocyanine green injected orally and anally to the tumor. Receives: Procedure: Sentinel node mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of procedures with successful identification of sentinel nodes
Sentinel nodes is defined as the lymph node, first in line, draining from the cancer.
Measured: day 1
Secondary outcomes (13)
Number of sentinel nodes identified during surgery and their localization
Measured: day 1
Number of sentinel nodes identified by ex vivo sentinel node mapping
Measured: week 1
Malignant status of the sentinel node(s)
Measured: week 1
Malignant status of the lymph nodes
Measured: week 1
Number of cases with negative sentinel node, but positive non-sentinel node
Measured: week 1
Localization of sentinel nodes with metastasis
Measured: 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
Measured: week 1
Number of cases where the sentinel node procedure has changed the clinical course of the patient
if staging and oncological treatment are changed because of the procedure
Measured: week 1
Number of procedures where the procedure is stopped due to technical reasons
Measured: day 1
Registration of possible side effects occurring due to the use of indocyanine green
Measured: day 1
Number of sentinel nodes identified by only one of the sentinel node mapping techniques
Measured: week 1
Total number of lymph nodes
Measured: week 1
Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ismail Gögenür
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ismail Gögenür, Herlev Hospital
- Investigators
- Ismail Gögenur, Professor, Principal investigator, Professor at University Hospital Køge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167087
- Sponsor's protocol ID
- SENSE2014
- Acronym
- SENSE
- Status last verified
- Feb 2016
- First submitted
- 6 Jun 2014
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie.
- ClinicalTrials.gov ID
- NCT02167087
- Acronym / sponsor ID
- SENSE / SENSE2014
- Conditions
- Colon Cancer, Lymphatic Metastasis
- Keywords
- Sentinel node mapping, lymphatic mapping, lymphatic metastasis, Aberrant lymphatic drainage, indocyanine green, ICG, near infrared, colon cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ismail GögenürUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Jun 2014 (estimated)
- 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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel node mapping | Experimental | Procedure: Sentinel node mappingSentinel node mapping with indocyanine green injected orally and anally to the tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Sentinel node mappingAlso: Karl Storz ICG system, to visualize the fluorescence, Indocyanine green, PULSION medical systems., Single use aspiration needle, NA-220H-8025 from Olympus.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. | Procedure or surgery | Sentinel node mapping |
Primary outcome
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.
13 secondary outcomes
Number of sentinel nodes identified during surgery and their localization
Time frame: day 1
Number of sentinel nodes identified by ex vivo sentinel node mapping
Time frame: week 1
Malignant status of the sentinel node(s)
Time frame: week 1
Malignant status of the lymph nodes
Time frame: week 1
Number of cases with negative sentinel node, but positive non-sentinel node
Time frame: week 1
Localization of sentinel nodes with metastasis
Time frame: 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
Number of cases where the sentinel node procedure has changed the clinical course of the patient
Time frame: week 1
Number of procedures where the procedure is stopped due to technical reasons
Time frame: day 1
Registration of possible side effects occurring due to the use of indocyanine green
Time frame: day 1
Number of sentinel nodes identified by only one of the sentinel node mapping techniques
Time frame: week 1
Total number of lymph nodes
Time frame: week 1
Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines
Time frame: week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ismail Gögenur, Professor principal investigator
Professor at University Hospital Køge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel node mapping in people with Colon Cancer and Lymphatic Metastasis, run by Ismail Gögenür at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 17 Feb 2016. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of procedures with successful identification of sentinel nodes (time frame: day 1). 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 17 Feb 2016.