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

NCT03024398 | Unknown

• 1 other identifier: 6492
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Detection of sentinel node

  1 hour after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with confirmed biopsy endometrial cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de gynécologie-obstétrique - Hôpital de Hautepierre

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Cherif Youssef AKLADIOS, MD

  University Hospital, Strasbourg, France

  STUDY DIRECTOR

Central Study Contacts

Cherif Youssef AKLADIOS, MD

CONTACT

33 3 88 12 83 35; cherif.youssef.azer@chru-strasbourg.fr

Jean-Jacques BALDAUF, MD, PhD

CONTACT

33 3 88 12 83 35; Jean-Jacques.Baldauf@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 18, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)