Using fluorescent dye to find lymph nodes in endometrial cancer
Evaluation of the Fluorescent Green of Indocyanine in the Detection of Sentinel Lymph Node in Endometrial Cancer
This study is testing if a special fluorescent dye can help doctors find lymph nodes more accurately in patients with endometrial cancer during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT03024398 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of using fluorescent green indocyanine dye for detecting sentinel lymph nodes in patients with endometrial cancer. The technique aims to improve detection rates and reduce false negatives compared to traditional lymphadenectomy methods. By utilizing advanced immunohistochemistry techniques, the study seeks to enhance the identification of metastases, particularly in patients at intermediate and high risk. The study will involve patients who require surgical staging and have confirmed endometrial cancer.
Who should consider this trial
Good fit: Ideal candidates are patients with confirmed endometrial cancer at FIGO stage I with intermediate to high risk, who require surgical staging.
Not a fit: Patients with advanced endometrial cancer (FIGO stage III and IV) or those who have undergone procedures that may alter lymphatic drainage will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate staging and treatment of endometrial cancer, potentially improving patient outcomes.
How similar studies have performed: Early studies using similar techniques in other cancers have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Strasbourg
- Service de gynécologie-obstétrique - Hôpital de Hautepierre — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Cherif Youssef AKLADIOS, MD
- Email: cherif.youssef.azer@chru-strasbourg.fr
- Phone: 33 3 88 12 83 35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.