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

Cancer of the Endometrium Clinical Trial

— Sentimetre  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03024398
• Other study ID #: 6492
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2023
• Source: University Hospital, Strasbourg, France
• Contact: Cherif Youssef AKLADIOS, MD
• Phone: 33 3 88 12 83 35
• Email: cherif.youssef.azer[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of the Endometrium
• Endometrial Neoplasms

Locations

Country	Name	City	State
France	Service de gynécologie-obstétrique - Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of sentinel node		1 hour after surgery