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

Study Overview
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Brief Summary
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This pilot clinical trial studies how well intravital microscopy works in evaluating patients with primary peritoneal, fallopian tube, or stage IA-IV ovarian cancer. Intravital microscopic evaluation of tumor blood vessels, blood flow, immune cell interactions, and drug uptake may be eventually visualized and may lead to valuable prognostic information.

Detailed Description
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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.

Official Title
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A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Conditions
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Primary Peritoneal Carcinoma, Stage IIA Ovarian Cancer, Stage IIB Ovarian Cancer, Stage IIC Ovarian Cancer, Fallopian Tube Carcinoma, Stage I Ovarian Cancer, Stage IA Ovarian Cancer, Stage IB Ovarian Cancer, Stage IC Ovarian Cancer, Stage II Ovarian Cancer, Stage III Ovarian Cancer, Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer

Intervention / Treatment
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* Procedure: Diagnostic Microscopy
* Drug: Fluorescein Sodium Injection
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (intravital microscopy)<br>Patients receive fluorescein sodium injection IV. Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery. | Procedure: Diagnostic Microscopy<br>* Undergo observation via intravital microscopy<br>Drug: Fluorescein Sodium Injection<br>* Given IV<br>* Other names: Fluorescite;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein within the tumor vessels | Will visualize fluorescein within the tumor vessels. | Up to 2 years | 
| Identification of tumor vessels | Will identify tumor vessels. | Up to 2 years | 
| Tumor vessel diameter | Will measure tumor vessel diameters. | Up to 2 years | 
| Vessel density | Will determine vessel density per 10 x field. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow velocity of the tumor vessels | Will assess the ability to measure the blood flow velocity of the tumor vessels. | Up to 2 years | 
| Tissue penetration of fluorescein | Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability. | Up to 2 years |