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

Roswell Park Comprehensive Cancer Center

Status and phase: Completed; Early Phase 1

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

Treatments: Procedure: Diagnostic Microscopy; Other: Laboratory Biomarker Analysis; Drug: Fluorescein Sodium Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03297489

NCI-2017-01459 (Registry Identifier)

I 43717 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Diagnostic (intravital microscopy)

Experimental group

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.

Treatment:

Drug: Fluorescein Sodium Injection

Other: Laboratory Biomarker Analysis

Procedure: Diagnostic Microscopy