Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

PRIMARY OBJECTIVES:

I. To determine the detection rate, sensitivity, and negative predictive value of sentinel
lymph node (SLN) biopsy in endometrial cancer patients.

SECONDARY OBJECTIVES:

I. To compare different surgical modalities (open procedures, minimally invasive procedures,
and single-site technology) and different injectants (isosulfan blue and indocyanine green)
for SLN biopsy.

II. To determine total operating room time (from the time the patient enters the room to the
time the patient leaves the room) as well as console time (robotic)/operating time for
minimally invasive procedures.

OUTLINE:

Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected
directly into the cervix. Following SLN identification and biopsy, patients undergo
hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy.
Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.

After completion of study treatment, patients are followed up at 2-4 weeks.

Inclusion Criteria:

- Women must have newly diagnosed histologically or cytologically confirmed endometrial
cancer

- Women should have received no prior therapy for their disease

- Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and
pelvic lymphadenectomy for the management of their endometrial cancer

- Women must have the ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- Women who are receiving any other investigational agents

- Women with a history of allergic reactions attributed to compounds of similar chemical
or biologic composition to isosulfan blue or indocyanine green or other agents used in
this study

- Women with hypersensitivity to phenylmethane compounds, or a history of allergic
reaction to iodides

- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements

- Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone
procedures performed on their cervix

- Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman
disease)

- Women with a history of a prior malignancy

- Women may also be excluded at the discretion of their surgeon if he or she feels that
the patient is not an appropriate candidate