ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer (ISCAPE)

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

Study Overview

• Status: Completed
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: lymphatic mapping with indocyanine green

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 192289
    • N.N. Petrov National Medical Research Center of Oncology

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid)
2. TNM T1-4a N0-2 M0-1
3. Clinical indications to colonic resection
4. ECOG - 0-2
5. Signed informed consent.

Exclusion Criteria:

1. Medical or psychiatric reasons interfering with patient's decision to participate in the study.
2. Pregnancy or breastfeeding.
3. Medical conditions contraindicating surgical procedure.
4. Acute bowel obstruction, bleeding or perforation.
5. Hypersensitivity to indocyanine green, sodium iodide or iodine
6. Hyperthyroidism or autonomic thyroid adenomas
7. Kidney failure of any aetiology
8. Hepatic failure of any aetiology
9. Poorly tolerated indocyanine injection in the past.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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: interventional; lymphatic mapping by indocyanine green	Procedure: lymphatic mapping with indocyanine green; subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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+	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of adverse events related to ICG lymphatic mapping	proportion of patients facing adverse events related to ICG lymphatic mapping procedure	30 days
feasibility of ICG lymphatic mapping for colon cancer	proportion of ICG spillage affecting interpretation	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	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	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	duration of surgical procedure

Collaborators and Investigators

• Sponsor: N.N. Petrov National Medical Research Center of Oncology
• Investigators: Study Director: Aleksey Karachun, PhD, N.N. Petrov National Medicine Research Center of oncology

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Actual): February 27, 2024
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: colon cancer; indocyanine green; lymphatic mapping
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms
• Other Study ID Numbers: ISC-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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