NCT03024398

Evaluation of the Fluorescent Green of Indocyanine in the Detection of Sentinel Lymph Node in Endometrial Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Selective lymphadenectomy Sentinel (LSS). This technique is already well established in breast cancer and melanoma and more recently in vulvar and cervical cancer. Compared to lymphadenectomy, it has several theoretical advantages: * this is a sensitive technique with a detection rate of\> 90% and a false negative rate of \<5%. * the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin antibodies, serial sections) are more sensitive than the standard histological analysis of lymphadenectomy, which allows an improvement in the detection of metastases (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in 15% of intermediate-risk patients. * it avoids short-term and long-term operative and post-operative morbidity of lymphadenectomy. Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric method coupled with the Technetium 99m isotopic method with an overall detection rate of 78% \[95% CI: 73-84\]. The fluorescent green of indocyanine appears to give better results with an overall detection rate of 94% and a bilateral detection rate of 80%. It seemed useful to take stock of this technique using this new dye.

Conditions

• Cancer of the Endometrium

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2017-01-18
• Last updated: 2023-06-18

Locations

1 site across 1 country: France