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

Brief Title

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

Official Title

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

Brief Summary

      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

      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.

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Fluorescein within the tumor vessels

Secondary Outcome

 Blood flow velocity of the tumor vessels

Condition

Fallopian Tube Carcinoma

Intervention

Diagnostic Microscopy

Study Arms / Comparison Groups

 Diagnostic (intravital microscopy)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

November 6, 2017

Completion Date

May 15, 2022

Primary Completion Date

May 15, 2021

Eligibility Criteria

        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)

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kunle Odunsi, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03297489

Organization ID

I 43717

Secondary IDs

NCI-2017-01459

Responsible Party

Sponsor

Study Sponsor

Roswell Park Cancer Institute

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Kunle Odunsi, Principal Investigator, Roswell Park Cancer Institute

Verification Date

January 2020