Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer

PRIMARY OBJECTIVES:

I. To determine the feasibility of performing intravital microscopy on accessible human
ovarian, primary peritoneal and fallopian tube cancers during their standard course of
treatment (i.e., surgical debulking).

SECONDARY OBJECTIVES:

I. To determine the blood flow velocity of the tumor vessels and tissue penetration of
fluorescein as a marker of tumor vessel permeability.

OUTLINE:

Patients receive fluorescein sodium injection intravenously (IV). Patients also undergo
observation of primary and metastatic tumors via microscopy over 15-20 minutes during the
course of standard of care surgery.

After completion of study, patients are followed up for 30 days, at 1-3 weeks, and then up to
2 years.

Inclusion Criteria:

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Suspicion of gynecological malignancy that requires a standard of care surgical
resection in the operating room;

- Have measurable lesion in the pelvis or abdomen, at a minimum of 0.5 cm in diameter on
standard of care pre operative imaging studies (CT, MRI or PET scan),

- Subject or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

- Serum Creatinine <= 1.5 X upper limit of normal (ULN) OR measured or calculated
creatinine clearance ≥ 60 mL/min for participant with creatinine levels > 1.5 X
institutional ULN (using Cockcroft-Gault Equation), GFR can also be used in place of
creatinine or CrCl.

Exclusion Criteria:

- 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

- Any known allergy or prior reaction to fluorescein

- Nursing female subjects

- Liver dysfunction; normal liver function defined as total bilirubin within normal
institutional limits and aspartate aminotransferase (AST) (serum glutamic-oxaloacetic
transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate
transaminase [SGPT]) =< 2.5 X institutional upper limit of normal

- Any condition which in the Investigator's opinion deems the subject an unsuitable
candidate to undergo observational study (may also include preoperative testing
results including electrocardiography (EKG), chest x-ray, or pulmonary function tests
that preclude a wide excision in the operating room)