This phase I trial studies how well intravital microscopy works in evaluating patients with gynecological malignancies. 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03297489.
PRIMARY OBJECTIVE:
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 OBJECTIVE:
I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein as a marker of tumor vessel permeability.
TERTIARY OBJECTIVES:
I. To determine the interactions of ex vivo fluorescein radio labeled autologous lymphocytes in the tumor microvasculature.
II. To determine the interactions of ex-vivo fluorescein radio labeled autologous lymphocytes in the normal appearing omentum vasculature during their standard course of treatment.
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 every 6 months for 2 years.
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorEmese Zsiros
