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

Early Phase 1

Completed

• Conditions: Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Stage IIB Ovarian Cancer; Stage IIIB Ovarian Cancer; Stage III Ovarian Cancer; Stage IC Ovarian Cancer; Stage IIA Ovarian Cancer; Stage IIC Ovarian Cancer; Stage I Ovarian Cancer; Stage IB Ovarian Cancer
• Interventions: Procedure: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection; Other: Laboratory Biomarker Analysis

• Registration Number: NCT03297489
• Lead Sponsor: Roswell Park Cancer Institute

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 Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-29
• Study Start: 2017-11-06
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (intravital microscopy)	Fluorescein Sodium Injection	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.
Diagnostic (intravital microscopy)	Laboratory Biomarker Analysis	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.
Diagnostic (intravital microscopy)	Diagnostic Microscopy	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.

Primary Outcome Measures

Name	Time	Method
Vessel density	Up to 2 years	Will determine vessel density per 10 x field.
Fluorescein within the tumor vessels	Up to 2 years	Will visualize fluorescein within the tumor vessels.
Identification of tumor vessels	Up to 2 years	Will identify tumor vessels.
Tumor vessel diameter	Up to 2 years	Will measure tumor vessel diameters.

Secondary Outcome Measures

Name	Time	Method
Blood flow velocity of the tumor vessels	Up to 2 years	Will assess the ability to measure the blood flow velocity of the tumor vessels.
Tissue penetration of fluorescein	Up to 2 years	Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States