Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging

Brief Summary:

Patients with early stage endometrial and cervical cancer who are undergoing robotic surgery
to remove the uterus, cervix and lymph nodes will have dye injected into the cervix after
they are asleep from anesthesia prior to performing the surgery. During the surgery, the
surgeon will activate the robotic camera that is being used to visualize the internal organs
changing it to a special mode of imaging called near infrared imaging. The near infrared
imaging will allow the surgeon to see where the dye that was injected into the cervix has
spread. The dye travels through vessels called lymphatic channels to nodules called "sentinel
lymph nodes". These are the tissues the surgeon is most interested in removing in order to
see if there has been spread of their cancer to those nodules. The dye that travels to the
lymph nodes makes them more easily visible to the surgeon. Without the dye, these nodes are
indistinguishable from the surrounding fatty tissue.

The nodes that have dye in them will be removed from the patient and sent to the pathologist,
where they will be very closely examined, called ultrasectioning, for cancer spread. The
surgeon will remove the remaining lymphatic tissue (all of the fatty and lymphatic tissue
that surrounded the sentinel lymph node that did not stain with the dye), as these are the
"non-sentinel lymph nodes", and are the tissue that is traditionally removed with endometrial
and cervical cancer surgery as part of standard of care. These non-sentinel lymph nodes will
also be examined for evidence of cancer spread. The researchers will compare the pathology
results from the sentinel nodes and non-sentinel nodes. The researchers hypothesize that the
sentinel nodes contain cancer cells at least 90% of the time when there is cancer found in
the non-sentinel nodes.

Inclusion Criteria:

- Patients must be women 18 years and older who have biopsy proven endometrial or
cervical carcinoma (of any histologic subtype).

- Surgical staging with the da Vinci Si robotic tool must be planned with a planned
pelvic and, in the case of endometrial cancer, a para-aortic lymphadenectomy

- Patients must meet criteria for robotic surgical approach:

- Patients must have either a clinical stage I endometrial (of any histologic grade) or
FIGO stage IA2 or IB1 (<4cm) cervical squamous, adenocarcinoma or adenosquamous
carcinoma.

- Patients must be able to sign an informed consent in English language.

- Patients with known liver disease will require normal range liver function tests as
determined by pre-operative labs drawn within 30 days of surgery.

Exclusion Criteria:

- Patients who have iodide allergies

- Patients who have had previous retroperitoneal surgery

- Patients on whom pelvic+/- para-aortic lymphadenectomy is not planned as part of their
surgical staging.

- Patients who have received previous treatment for their endometrial or cervical cancer
(particularly hysterectomy or pelvic radiation).

- Patients who are pregnant.

- Patients with documented liver disease who have abnormalities of liver function tests.