Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer

This is an interventional, prospective, and non-therapeutic study evaluating the clinical
utility of SLND for detecting nodal metastasis of early stage endometrial cancer.

Patients will undergo surgical staging for EC (sentinel lymph node dissection (SLND) via
laparotomy, laparoscopy or robotic surgery, ±hysterectomy, ±bilateral salpingo-oophorectomy
(BSO)). Pelvic and paraaortic lymphadenectomy may (or may not) also be performed in addition
to SLND, at the discretion of the Surgeon.

Sentinel lymph nodes (SLN) will be removed; that is, all patients will have SLND. Pelvic
washings may also be obtained. Pathology assessment of nodal metastasis will be performed in
all nodes removed (SLN or any other enlarged or removed lymph nodes).

Patients will be staged using International Federation of Gynecology and Obstetrics (FIGO)
criteria and classified into risk strata (either low or high risk EC) as per the Modified
Mayo Criteria. Based on the pathologic risk assessment and FIGO stage, patients may then be
assigned to receive adjuvant treatment at the discretion of the treating Investigator and as
per institutional guidelines; no per-protocol treatment is planned.

Inclusion Criteria:

- 1. Patients must have histologically and/or cytologically confirmed endometrial
cancer.

- 2. Clinically apparent early stage endometrial cancer (i.e. disease confined to the
uterus on preoperative work up).

- 3. Surgical candidate with operable tumor (patient is eligible and willing to undergo
surgery for the management of their endometrial cancer) as deemed by an institutional
surgeon.

- 4. Females aged 18 years or older.

- 5. Eastern Cooperative Oncology Group (ECOG)/Gynecologic Oncology Group (GOG)
performance status ≤ 2.

- 6. Patients must have normal organ and marrow function as defined below:

- White blood cells (WBC) ≥3,000/ul

- Platelets (PLT) ≥100,000/ul

- Total bilirubin > 2.0 x upper limits of institutional normal (ULN)

- Creatinine ≤ 1.5 x ULN (upper limits of institutional normal)

- 7. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

- 1. Patients with lymphadenopathy and/or evidence of metastases, either clinically
palpable and/or on preoperative radiological imaging.

- 2. Any preoperative adjuvant therapy for endometrial cancer (e.g. prior
pelvic/abdominal radiotherapy (RT), chemotherapy, or retroperitoneal surgery).

- 3. Patients may not be receiving any other investigational agents.

- 4. Pregnant or breastfeeding patients. A pregnancy test is required during Screening
for perimenopausal patients who did not have a hysterectomy.

- 5. Central Nervous System (CNS) restrictions (i.e. brain metastases).

- 6. History of allergic reactions or hypersensitivity attributed to compounds with
similar chemical or biologic composition to phenylmethane, iodines, isosulfan blue,
indigocyanine green (ICG) and any other agent(s) used in this study. If there is an
allergy to one of the possible compounds, a patient can be enrolled only if the
treating Investigator takes documented precautions to ensure the agent that the
patient is allergic to is not used.

- 7. Any uncontrolled, intercurrent illness including but not limited to concomitant
cancer, ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, or cardiac arrhythmia.

- 8. Any serious medical or psychiatric illness/condition likely in the judgment of the
Investigator(s) to interfere or limit compliance with study requirements/treatment.