Clinical trial · Interventional
ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer
NCT05468827CI-TRIAL-00091419ISCAPEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lymphatic mapping with indocyanine green | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- interventional
- description
- lymphatic mapping by indocyanine green
- interventionNames
- Procedure: lymphatic mapping with indocyanine green
Primary outcomes (1)
- measure
- proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG distribution
- timeFrame
- 30 days
- description
- number of patients with affected lymph nodes located within ICG distribution margins divided by the number of all patients with pN+
Secondary outcomes (5)
- measure
- incidence of adverse events related to ICG lymphatic mapping
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDPanaiotti 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. PMID 41099883