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

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Cancer of the Endometrium

Study type: Observational

Funder types: Other

Identifiers

NCT03024398

6492

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major patient, without guardianship or curatorship.
• patient with endometrial cancer confirmed by biopsy.
• Invasive cancer stage FIGO I at intermediate risk and high risk and II according to the FIGO classification.
• need for surgical staging.
• performing an endovaginal ultrasound or a pelvic MRI in preoperative, if contraindication to MRI, performing a CT scan.
• subject affiliated to a social health insurance scheme.
• speaking and reading French.
• subject having dated and signed informed consent.

Exclusion criteria

• pregnancy in progress.
• FIGO III and IV stage diagnosed preoperatively or intraoperatively.
• Cure or pre-surgery that may alter the uterine lymphatic drainage (conization, myomectomy).
• MRI or CT scan of suspected lymph nodes.