Clinical trial · Interventional
Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer
NCT02564276CI-TRIAL-00031372completedPhase 3ClinicalTrials.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)
To determine the difference in the proportion of hemipelves with successful detection of Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging vs blue dye) in women with endometrial cancer.
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 |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Indocyanine Green on the right side
- description
- Indocyanine Green will be injected on the right side of the cervix and Methylene blue on the left side of the cervix.
- interventionNames
- Procedure: Sentinel lymph node biopsy
- type
- EXPERIMENTAL
- label
- Methylene Blue on the right side
- description
- Methylene blue will be injected on the right side of the cervix and Indocyanine Green on the left side of the cervix.
- interventionNames
- Procedure: Sentinel lymph node biopsy
Primary outcomes (1)
- measure
- the difference in the proportion of hemipelves with successful detection of SLN according to the dye used
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * all patients with endometrial carcinoma proven by endometrial biopsy or curettage AND * preoperative FIGO (International Federation of Gynecology and Obstetrics) stage I AND * intended for staging via laparoscopic or robotic surgery AND * Patients must be older than 18 year-old, able to read French or English. Exclusion Criteria: * preoperative FIGO stages II to IV * previous pelvic or paraaortic lymphadenectomy or radiotherapy * surgery that could change the uterine lymphatic drainage (myomectomy) * iodine allergy * pregnancy.
References
Publications (8)
- RESULTCreasman WT, Morrow CP, Bundy BN, Homesley HD, Graham JE, Heller PB. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer. 1987 Oct 15;60(8 Suppl):2035-41. doi: 10.1002/1097-0142(19901015)60:8+3.0.co;2-8. PMID 3652025
- RESULTAbu-Rustum NR, Alektiar K, Iasonos A, Lev G, Sonoda Y, Aghajanian C, Chi DS, Barakat RR. The incidence of symptomatic lower-extremity lymphedema following treatment of uterine corpus malignancies: a 12-year experience at Memorial Sloan-Kettering Cancer Center. Gynecol Oncol. 2006 Nov;103(2):714-8. doi: 10.1016/j.ygyno.2006.03.055. Epub 2006 Jun 5. PMID 16740298
- RESULTDankert J, Bouma J. Recurrent acute leg cellulitis after hysterectomy with pelvic lymphadenectomy. Br J Obstet Gynaecol. 1987 Aug;94(8):788-90. doi: 10.1111/j.1471-0528.1987.tb03728.x. PMID 3663535
- RESULTQuerleu D, Leblanc E, Cartron G, Narducci F, Ferron G, Martel P. Audit of preoperative and early complications of laparoscopic lymph node dissection in 1000 gynecologic cancer patients. Am J Obstet Gynecol. 2006 Nov;195(5):1287-92. doi: 10.1016/j.ajog.2006.03.043. Epub 2006 May 3. PMID 16677594
- RESULTBarlin JN, Khoury-Collado F, Kim CH, Leitao MM Jr, Chi DS, Sonoda Y, Alektiar K, DeLair DF, Barakat RR, Abu-Rustum NR. The importance of applying a sentinel lymph node mapping algorithm in endometrial cancer staging: beyond removal of blue nodes. Gynecol Oncol. 2012 Jun;125(3):531-5. doi: 10.1016/j.ygyno.2012.02.021. Epub 2012 Feb 22. PMID 22366409
- RESULTDesai PH, Hughes P, Tobias DH, Tchabo N, Heller PB, Dise C, Slomovitz BM. Accuracy of robotic sentinel lymph node detection (RSLND) for patients with endometrial cancer (EC). Gynecol Oncol. 2014 Nov;135(2):196-200. doi: 10.1016/j.ygyno.2014.08.032. Epub 2014 Aug 28. PMID 25175452
- RESULTCormier B, Rozenholc AT, Gotlieb W, Plante M, Giede C; Communities of Practice (CoP) Group of Society of Gynecologic Oncology of Canada (GOC). Sentinel lymph node procedure in endometrial cancer: A systematic review and proposal for standardization of future research. Gynecol Oncol. 2015 Aug;138(2):478-85. doi: 10.1016/j.ygyno.2015.05.039. Epub 2015 Jun 3.