Brief Title
Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer
Official Title
A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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 Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Fluorescein within the tumor vessels
Secondary Outcome
Blood flow velocity of the tumor vessels
Condition
Fallopian Tube Carcinoma
Intervention
Diagnostic Microscopy
Study Arms / Comparison Groups
Diagnostic (intravital microscopy)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
19
Start Date
November 6, 2017
Completion Date
February 15, 2022
Primary Completion Date
February 15, 2021
Eligibility Criteria
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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Emese Zsiros, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03297489
Organization ID
I 43717
Secondary IDs
NCI-2017-01459
Responsible Party
Sponsor
Study Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Emese Zsiros, MD, Principal Investigator, Roswell Park Cancer Institute
Verification Date
May 2021