Lymph Node Mapping in Patients With Endometrial Cancer

PRIMARY OBJECTIVE:

I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in
endometrial cancer to predict nodal metastasis.

SECONDARY OBJECTIVE:

II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic
disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC
results and standard hematoxylin and eosin (H&E) results.

OUTLINE:

Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine
green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel
lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full
pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard
hysterectomy and salpingo-oophorectomy.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years for a total of 5 years according to the standard surveillance
guidelines for endometrial cancer.

Inclusion Criteria:

- The patient must be willing and able to provide informed consent

- The patient is willing and able to comply with the study protocol

- The patient has endometrial cancer and is scheduled for robotic hysterectomy and
lymphadenectomy

- The patient agrees to follow-up examinations out to 5-years post-treatment

Exclusion Criteria:

- The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy

- The patient has known or suspected allergies to iodine, indocyanine green (ICG) or
isosulfan blue (ISB)

- The patient has hepatic dysfunction confirmed by bilirubin > 2 x normal (based on
reference values from the laboratory used by the patient)