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NCT04351009
Sentinel Lymph Node Mapping and Analysis in Colon Cancer Using Indocyanine Green Dye
NA trial testing sentinel lymph node mapping in Colon Cancer in 48 participants. Completed in 30 June 2022.
30 June 2022
Quick facts
| Lead sponsor | Asian Institute of Gastroenterology, India |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 48 |
| Start date | 8 June 2020 |
| Primary completion | 30 June 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 1 location across India |
Drugs / interventions tested
- sentinel lymph node mapping
Conditions studied
- Colon Cancer — all drugs for Colon Cancer →
Sponsor
Asian Institute of Gastroenterology, India
Who can join
Adults 18 to 80, any sex, with Colon Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Crosstalk between Wnt/β-catenin signaling pathway and DNA damage response in cancer: a new direction for overcoming therapy resistance.
Zhang X, Yu X. · · 2023 · cited 19× · PMID 37601042 · DOI 10.3389/fphar.2023.1230822 -
Pharmacological targeting of the novel β-catenin chromatin-associated kinase p38α in colorectal cancer stem cell tumorspheres and organoids.
Lepore Signorile M, Grossi V, Di Franco S, Forte G, et al · · 2021 · cited 19× · PMID 33767160 · DOI 10.1038/s41419-021-03572-4 -
Indocyanine green guided sentinel lymph node biopsy may have a high sensitivity for early (T1/T2) colon cancer: A prospective study in Indian patients.
Ahmed Z, Patil SM, Sekaran A, Rebala P, et al · · 2023 · cited 5× · PMID 38058374 · DOI 10.47717/turkjsurg.2023.6106
Verify or expand the search:
- PubMed search for NCT04351009
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04351009 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asian Institute of Gastroenterology, India
- Last refreshed: 6 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04351009.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing