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

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ClinicalTrials.gov Identifier: NCT03297489
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Carcinoma 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 Procedure: Diagnostic Microscopy Drug: Fluorescein Sodium Injection Other: Laboratory Biomarker Analysis Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Procedure: Diagnostic Microscopy
Undergo observation via intravital microscopy

Drug: Fluorescein Sodium Injection
Given IV
Other Names:
  • AK-Fluor
  • Fluorescite

Other: Laboratory Biomarker Analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Fluorescein within the tumor vessels [ Time Frame: Up to 2 years ]
    Will visualize fluorescein within the tumor vessels.

  2. Identification of tumor vessels [ Time Frame: Up to 2 years ]
    Will identify tumor vessels.

  3. Tumor vessel diameter [ Time Frame: Up to 2 years ]
    Will measure tumor vessel diameters.

  4. Vessel density [ Time Frame: Up to 2 years ]
    Will determine vessel density per 10 x field.


Secondary Outcome Measures :
  1. Blood flow velocity of the tumor vessels [ Time Frame: Up to 2 years ]
    Will assess the ability to measure the blood flow velocity of the tumor vessels.

  2. Tissue penetration of fluorescein [ Time Frame: Up to 2 years ]
    Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297489


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: ASK RPCI    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Kunle Odunsi         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kunle Odunsi Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03297489    
Other Study ID Numbers: I 43717
NCI-2017-01459 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 43717 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders