Clinical trial · Interventional
Sentinel Lymph Node Mapping and Analysis in Colon Cancer Using Indocyanine Green Dye
Intra-operative Sentinel Lymph Node Mapping Using Indocyanine Green Dye Near-infrared Fluorescence Imaging in Colon Cancer: Prospective Single Center Study
- 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)
Approximately 20-30 % of colon cancer patients who have no metastasis in lymph nodes after definitive colectomy have recurrence with distant metastasis. These recurrences could be due to missed occult tumor cells or micrometastasis. Detailed examination of all lymph nodes is expensive and time consuming. Sentinel lymph node mapping using Indocyanine green dye helps in identifying the lymph nodes which are most likely to harbour metastasis. These sentinel lymph nodes can be subsequently subjected to detailed pathologic examination and immunohistochemistry which increases the likelihood of identifying micrometastasis and occult tumor cells. Patients found to harbour such metastasis can be treated with additional chemotherapy after surgery. The aim of the study is to examine the feasibility of sentinel lymph node mapping using Indocyanine green dye in colon cancer and evaluate the upstaging rate in post-operative colon cancer patients who don't have metastatic lymph nodes on routine histopathology.
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 |
|---|---|---|---|
| sentinel lymph node mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Indocyanine green sentinel lymph node mapping
- description
- Indocyanine green dye is injected in the submucosa or subserosa around the tumor to identify sentinel lymph nodes intra-operatively with near infrared fluorescence imaging.
- interventionNames
- Procedure: sentinel lymph node mapping
Primary outcomes (2)
- measure
- Detection rate
- timeFrame
- 2 years
- description
- Proportion of the number of successful sentinel lymph node procedures out of all executed sentinel lymph node procedures.
- measure
- Upstaging rate
- timeFrame
- 2 years
- description
- Sentinel lymph nodes in patients are pathologically node negative on routine evaluation with undergo detailed evaluation using serial sections and immunohistochemistry to identify micrometastasis and occult tumor cells. The proportion of node negative patients who are upstaged will be calculated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: Age 18 years or older Biopsy proven colon cancer Scheduled for laparoscopic/open colectomy Exclusion criteria: Prior colorectal surgery Gross lymph node invasion on pre-operative imaging or intraoperative staging Advanced disease (T4 disease or metastasis) on preoperative imaging or intraoperative staging Allergy to iodide containing compounds, human albumin or Indocyanine green dye History of hyperthyroidism or thyroid adenoma Palliative surgery Advanced hepatic failure Advanced renal failure
References
Publications (0)
Data not yet available