Colon CancerISCAPENCT05468827
ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer
A study testing lymphatic mapping with indocyanine green in people with Colon Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
The study is aimed at investigating feasibility of defining colon resection margins for colon cancer with ICG by comparing lymphatic distribution of subserosally injected dye with actual spread of lymphatic metastases reported by pathologists after specimen examination Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- lymphatic mapping with indocyanine green
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteRussia
- Study dates
- 26 Jul 2022to 14 Mar 2024
- 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
- Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid)
- TNM T1-4a N0-2 M0-1
- Clinical indications to colonic resection
- ECOG - 0-2
- Signed informed consent.
Who cannot join
- Medical or psychiatric reasons interfering with patient's decision to participate in the study.
- Pregnancy or breastfeeding.
- Medical conditions contraindicating surgical procedure.
- Acute bowel obstruction, bleeding or perforation.
- Hypersensitivity to indocyanine green, sodium iodide or iodine
- Hyperthyroidism or autonomic thyroid adenomas
Show all 9Show fewer
- Kidney failure of any aetiology
- Hepatic failure of any aetiology
- Poorly tolerated indocyanine injection in the past.
Trial locations and contacts
1 site in 1 country.
Russia1 site
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 192289
About this study
The study is aimed at investigating feasibility of defining colon resection margins for colon cancer with ICG by comparing lymphatic distribution of subserosally injected dye with actual spread of lymphatic metastases reported by pathologists after specimen examination
Read the detailed description
In this study 2.5 mg/ml indocyanine green solution is injected subserosally into colonic wall near the tumour in 4 points (1 ml each). The fluorescence is assessed before specimen removal (at least 30 min after injection) and its mesenteric distribution is marked by surgeon on the specimen. Proximal and distal colonic resection margins are chosen to be at least 10 cm long and to include the whole area of fluorescence. After removal, lymphatic node groups according JSCCR are also marked on fresh specimen. During pathological examination each lymph node is assessed not only for presence of metastases but also for its exact location in relation to margins of indocyanine distribution.
- Conditions
- Colon Cancer
- Being tested
- lymphatic mapping with indocyanine green
- Keywords
- colon cancer, lymphatic mapping, indocyanine green
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphatic mapping with indocyanine greenProcedure or surgery
subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | lymphatic mapping by indocyanine green Receives: Procedure: lymphatic mapping with indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG distribution
number of patients with affected lymph nodes located within ICG distribution margins divided by the number of all patients with pN+
Measured: 30 days
Secondary outcomes (5)
incidence of adverse events related to ICG lymphatic mapping
proportion of patients facing adverse events related to ICG lymphatic mapping procedure
Measured: 30 days
feasibility of ICG lymphatic mapping for colon cancer
proportion of ICG spillage affecting interpretation
Measured: duration of surgical procedure
incidence of lymph node metastases outside conventional resection margins (10 cm)
proportion of patients with aberrant lymphatics leading to affected lymph nodes
Measured: 30 days
colon cancer lymphatic spread pattern
descriptive data on incidence of D1, D2 and D3 lymphatic collector metastases and frequences of D1 collector metastases depending on distance from primary tumour
Measured: 30 days
feasibility of ICG mapping for colon flexure tumours
proportion of operations for colon flexure tumours which extent is effected by ICG lymphatic mapping
Measured: duration of surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start26 Jul 2022
- Primary completion27 Feb 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- all study participants are allocated to intraoperative ICG mapping of locoregional lymphatic collector
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksey Karachun, PhD, Study director, N.N. Petrov National Medicine Research Center of oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468827
- Sponsor's protocol ID
- ISC-1
- Acronym
- ISCAPE
- Status last verified
- Jun 2025
- First submitted
- 18 Jul 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Panaiotti L, Karachun A, Muravtseva A, Golovanova T, Khaetskaya M, Shkatov M, Petrov A. Indocyanine green (ICG) fluorescence guided lymph node mapping for determination of resection margins in colon cancer - ISCAPE trial. Tech Coloproctol. 2025 Oct 16;29(1):179. doi: 10.1007/s10151-025-03222-3.
PubMed 41099883
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer
- ClinicalTrials.gov ID
- NCT05468827
- Acronym / sponsor ID
- ISCAPE / ISC-1
- Conditions
- Colon Cancer
- Keywords
- colon cancer, lymphatic mapping, indocyanine green
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 21 Jul 2022 (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 study is aimed at investigating feasibility of defining colon resection margins for colon cancer with ICG by comparing lymphatic distribution of subserosally injected dye with actual spread of lymphatic metastases reported by pathologists after specimen examination
Detailed description
In this study 2.5 mg/ml indocyanine green solution is injected subserosally into colonic wall near the tumour in 4 points (1 ml each). The fluorescence is assessed before specimen removal (at least 30 min after injection) and its mesenteric distribution is marked by surgeon on the specimen. Proximal and distal colonic resection margins are chosen to be at least 10 cm long and to include the whole area of fluorescence. After removal, lymphatic node groups according JSCCR are also marked on fresh specimen. During pathological examination each lymph node is assessed not only for presence of metastases but also for its exact location in relation to margins of indocyanine distribution.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all study participants are allocated to intraoperative ICG mapping of locoregional lymphatic collector
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Procedure: lymphatic mapping with indocyanine greenlymphatic mapping by indocyanine green |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid)
- TNM T1-4a N0-2 M0-1
- Clinical indications to colonic resection
- ECOG - 0-2
- Signed informed consent.
Key exclusion criteria (9 listed)
- Medical or psychiatric reasons interfering with patient's decision to participate in the study.
- Pregnancy or breastfeeding.
- Medical conditions contraindicating surgical procedure.
- Acute bowel obstruction, bleeding or perforation.
- Hypersensitivity to indocyanine green, sodium iodide or iodine
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 |
|---|---|---|
| lymphatic mapping with indocyanine greensubserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics | Procedure or surgery | interventional |
Primary outcome
proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG distribution
Time frame: 30 days
number of patients with affected lymph nodes located within ICG distribution margins divided by the number of all patients with pN+
5 secondary outcomes
incidence of adverse events related to ICG lymphatic mapping
Time frame: 30 days
feasibility of ICG lymphatic mapping for colon cancer
Time frame: duration of surgical procedure
incidence of lymph node metastases outside conventional resection margins (10 cm)
Time frame: 30 days
colon cancer lymphatic spread pattern
Time frame: 30 days
feasibility of ICG mapping for colon flexure tumours
Time frame: duration of surgical procedure
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 26 Jun 2025.
- Derived from this study: PubMed 41099883Panaiotti L, Karachun A, Muravtseva A, Golovanova T, Khaetskaya M, Shkatov M, Petrov A. Indocyanine green (ICG) fluorescence guided lymph node mapping for determination of resection margins in colon cancer - ISCAPE trial. Tech Coloproctol. 2025 Oct 16;29(1):179. doi: 10.1007/s10151-025-03222-3.
- Individual participant dataSharing planned: No
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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.
Aleksey Karachun, PhD study director
N.N. Petrov National Medicine Research Center of oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymphatic mapping with indocyanine green in people with Colon Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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 5 inclusion and 9 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 26 Jun 2025. 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 Russia. 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?
proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG distribution (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05468827, which also lists 1 linked publication.
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 26 Jun 2025.