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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer of the Endometrium

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Cherif Youssef AKLADIOS, MD; Phone Number: 33 3 88 12 83 35; Email: cherif.youssef.azer@chru-strasbourg.fr
• Study Contact Backup: Name: Jean-Jacques BALDAUF, MD, PhD; Phone Number: 33 3 88 12 83 35; Email: Jean-Jacques.Baldauf@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de gynécologie-obstétrique - Hôpital de Hautepierre
    • Contact: Cherif Youssef AKLADIOS, MD; Phone Number: 33 3 88 12 83 35; Email: cherif.youssef.azer@chru-strasbourg.fr
    • Contact: Jean-Jacques BALDAUF, MD, PhD; Phone Number: 33 3 88 12 83 35; Email: Jean-Jacques.Baldauf@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with confirmed biopsy endometrial cancer

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection of sentinel node	1 hour after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Study Director: Cherif Youssef AKLADIOS, MD, University Hospital, Strasbourg, france

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 1, 2023

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimated): January 18, 2017

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: 6492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO