RecruitingNot ApplicableNCT06163963

Sentinel Lymph Node in Early-Stage Endometrium Cancer

Sentinel Lymph Node Mapping with Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer


Sponsor

Istanbul University

Enrollment

100 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this prospective study is to investigate whether the detection rate of sentinel lymph node (SLN) with double tracer injected at two different sites may be increased compared to the standard use of a single tracer with single site (cervix) injection in early-stage endometrial cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the use of sentinel lymph node biopsy — a technique to identify the first lymph node that cancer might spread to — in women with early-stage uterine (endometrial) cancer. By removing and testing only this key node, surgeons may be able to avoid removing all pelvic lymph nodes and reduce complications. **You may be eligible if...** - You are an adult woman with early-stage endometrial (uterine) cancer (Stage I or II) - You are scheduled for surgical treatment (hysterectomy) - Your cancer has not spread beyond the uterus based on initial imaging **You may NOT be eligible if...** - Your cancer is at an advanced stage or has spread to lymph nodes or distant organs - You have had prior pelvic radiation or surgery that would affect lymph node mapping - You are allergic to the dye used for sentinel node detection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer

This is a single arm interventional prospective study. Sentinel lymph node detection rate of the tracer injected in cervix (ICG- indocyanine green) before operation and the second tracer injected in uterine fundal subserosa (sterile charcoal black) at the start of operation are investigated. It is anticipated that additional tracer used in the uterine serosa may overcome the insufficiency (or increase the detection rate) of the standard single tracer injected in cervix for detection rate of sentinel lymph nodes, especially in paraaortic sentinel lymph nodes.

DIAGNOSTIC_TESTcharcoal injection to uterus to map sentinel lymph nodes

During surgery for endometrial cancer, charcoal injection to uterus to map sentinel lymph nodes in para aortic area besides the classic ınjection of indocyanine green for pelvic sentinel lymph node mapping.


Locations(1)

Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology

Istanbul, Istanbul / Turkey, Turkey (Türkiye)

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NCT06163963


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