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

NCT05468827 | Completed DMC

• 1 other identifier: ISC-1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colon Cancer

Keywords

colon cancer; lymphatic mapping; indocyanine green

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• incidence of adverse events related to ICG lymphatic mapping

  30 days

• feasibility of ICG lymphatic mapping for colon cancer

  duration of surgical procedure

• incidence of lymph node metastases outside conventional resection margins (10 cm)

  30 days

• colon cancer lymphatic spread pattern

  30 days

• feasibility of ICG mapping for colon flexure tumours

  duration of surgical procedure

Study Arms (1)

interventional

EXPERIMENTAL

lymphatic mapping by indocyanine green

Procedure: lymphatic mapping with indocyanine green

Interventions

lymphatic mapping with indocyanine green PROCEDURE

subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics

interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Kidney failure of any aetiology
• Hepatic failure of any aetiology
• Poorly tolerated indocyanine injection in the past.

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, 192289, Russia

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Aleksey Karachun, PhD

  N.N. Petrov National Medicine Research Center of oncology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: all study participants are allocated to intraoperative ICG mapping of locoregional lymphatic collector

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: July 26, 2022
• Primary Completion: February 27, 2024
• Study Completion: March 14, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)