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

Primary Peritoneal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297489
• Other study ID #: I 43717
• Secondary ID: NCI-2017-01459I
• Status: Completed
• Phase: Early Phase 1
• Start date: November 6, 2017
• Est. completion date: February 15, 2021

Study information

• Verified date: October 2021
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Carcinoma
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Stage I Ovarian Cancer
• Stage IA Ovarian Cancer
• Stage IB Ovarian Cancer
• Stage IC Ovarian Cancer
• Stage II Ovarian Cancer
• Stage IIA Ovarian Cancer
• Stage IIB Ovarian Cancer
• Stage IIC Ovarian Cancer
• Stage III Ovarian Cancer
• Stage IIIA Ovarian Cancer
• Stage IIIB Ovarian Cancer
• Stage IIIC Ovarian Cancer
• Stage IV Ovarian Cancer

Intervention

Procedure:
• Diagnostic Microscopy
Undergo observation via intravital microscopy

Drug:
• Fluorescein Sodium Injection
Given IV

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescein within the tumor vessels	Will visualize fluorescein within the tumor vessels.	Up to 2 years
Primary	Identification of tumor vessels	Will identify tumor vessels.	Up to 2 years
Primary	Tumor vessel diameter	Will measure tumor vessel diameters.	Up to 2 years
Primary	Vessel density	Will determine vessel density per 10 x field.	Up to 2 years
Secondary	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
Secondary	Tissue penetration of fluorescein	Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability.	Up to 2 years