Skip to main content
OpenTrials
Completed

NCT Number: NCT05468827

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, 192289, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

lymphatic mapping with indocyanine green

Procedure

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

Primary outcomes

  1. 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+

Secondary outcomes

  1. incidence of adverse events related to ICG lymphatic mapping

    Time frame: 30 days

    proportion of patients facing adverse events related to ICG lymphatic mapping procedure

  2. feasibility of ICG lymphatic mapping for colon cancer

    Time frame: duration of surgical procedure

    proportion of ICG spillage affecting interpretation

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

    Time frame: 30 days

    proportion of patients with aberrant lymphatics leading to affected lymph nodes

  4. colon cancer lymphatic spread pattern

    Time frame: 30 days

    descriptive data on incidence of D1, D2 and D3 lymphatic collector metastases and frequences of D1 collector metastases depending on distance from primary tumour

  5. feasibility of ICG mapping for colon flexure tumours

    Time frame: duration of surgical procedure

    proportion of operations for colon flexure tumours which extent is effected by ICG lymphatic mapping

Sponsors and collaborators

Lead sponsor

N.N. Petrov National Medical Research Center of Oncology

Other

Registry information

Acronym: ISCAPE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2022
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.