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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03024398
Acronym
Sentimetre
Enrollment
50
Registered
2017-01-18
Start date
2017-01-01
Completion date
2023-07-01
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the Endometrium

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.

Interventions

None listed

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Detection of sentinel node1 hour after surgery

Countries

France

Contacts

Primary ContactCherif Youssef AKLADIOS, MD
cherif.youssef.azer@chru-strasbourg.fr33 3 88 12 83 35
Backup ContactJean-Jacques BALDAUF, MD, PhD
Jean-Jacques.Baldauf@chru-strasbourg.fr33 3 88 12 83 35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026