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.

• Diagnostic Microscopy (Procedure): Undergo observation via intravital microscopy
• Fluorescein Sodium Injection (Drug), also known as AK-Fluor, Fluorescite: Given IV
• Laboratory Biomarker Analysis (Other): Correlative studies

Primary outcomes

• Fluorescein within the tumor vessels [Up to 2 years]: Will visualize fluorescein within the tumor vessels.
• Identification of tumor vessels [Up to 2 years]: Will identify tumor vessels.
• Tumor vessel diameter [Up to 2 years]: Will measure tumor vessel diameters.
• Vessel density [Up to 2 years]: Will determine vessel density per 10 x field.

Secondary outcomes

• Blood flow velocity of the tumor vessels [Up to 2 years]: Will assess the ability to measure the blood flow velocity of the tumor vessels.
• Tissue penetration of fluorescein [Up to 2 years]: Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability.

Sex: Female, ages: 18 Years to any

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)

• Emese Zsiros, MD, Principal investigator, Roswell Park Cancer Institute