Intravital Microscopy in Evaluating Patients with Gynecological Malignancies

Status: Active

Description

This phase I pilot 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.

Eligibility Criteria

Inclusion Criteria

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Suspicion of gynecological malignancies that requires a standard of care surgical resection in the operating room
  • Have a measurable lesion in the pelvis or abdomen, at a minimum of 0.5 cm in diameter on standard of care pre-operative imaging studies (computed tomography [CT], magnetic resonance imaging [MRI] or positron emission tomography [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), glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (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)

Locations & Contacts

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Kunle Odunsi
Phone: 716-845-8376
Email: Kunle.Odunsi@roswellpark.org

Trial Objectives and Outline

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.

TERTIARY OBJECTIVES:

I. To determine the interactions of ex vivo fluorescein radio labeled autologous lymphocytes in the tumor microvasculature.

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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
Roswell Park Cancer Institute

Principal Investigator
Kunle Odunsi

Trial IDs

Primary ID I 43717
Secondary IDs NCI-2017-01459
Clinicaltrials.gov ID NCT03297489