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

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

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.

Study Overview

• Status: Completed
• Conditions: Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Stage IIA Ovarian Cancer; Stage IIB Ovarian Cancer; Stage IIC Ovarian Cancer; Stage IIIA Ovarian Cancer; Stage IIIB Ovarian Cancer; Stage IIIC Ovarian Cancer; Stage IV Ovarian Cancer; Stage IA Ovarian Cancer; Stage IB Ovarian Cancer; Stage IC Ovarian Cancer; Stage III Ovarian Cancer; Stage II Ovarian Cancer; Stage I Ovarian Cancer
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Drug: Fluorescein Sodium Injection; Procedure: Diagnostic Microscopy

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (intravital 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Fluorescein Sodium Injection; Given IV; Other Names: AK-Fluor; Fluorescite; Procedure: Diagnostic Microscopy; Undergo observation via intravital microscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: I 43717 (Other Identifier: Roswell Park Cancer Institute); NCI-2017-01459 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No