<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03297489</url>
  </required_header>
  <id_info>
    <org_study_id>I 43717</org_study_id>
    <secondary_id>NCI-2017-01459</secondary_id>
    <secondary_id>I 43717</secondary_id>
    <nct_id>NCT03297489</nct_id>
  </id_info>
  <brief_title>Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer</brief_title>
  <official_title>A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well intravital microscopy works in evaluating patients&#xD;
      with primary peritoneal, fallopian tube, or stage IA-IV ovarian cancer. Intravital&#xD;
      microscopic evaluation of tumor blood vessels, blood flow, immune cell interactions, and drug&#xD;
      uptake may be eventually visualized and may lead to valuable prognostic information.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the feasibility of performing intravital microscopy on accessible human&#xD;
      ovarian, primary peritoneal and fallopian tube cancers during their standard course of&#xD;
      treatment (i.e., surgical debulking).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the blood flow velocity of the tumor vessels and tissue penetration of&#xD;
      fluorescein as a marker of tumor vessel permeability.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive fluorescein sodium injection intravenously (IV). Patients also undergo&#xD;
      observation of primary and metastatic tumors via microscopy over 15-20 minutes during the&#xD;
      course of standard of care surgery.&#xD;
&#xD;
      After completion of study, patients are followed up for 30 days, at 1-3 weeks, and then up to&#xD;
      2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2017</start_date>
  <completion_date type="Actual">February 15, 2021</completion_date>
  <primary_completion_date type="Actual">February 15, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fluorescein within the tumor vessels</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will visualize fluorescein within the tumor vessels.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of tumor vessels</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will identify tumor vessels.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor vessel diameter</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will measure tumor vessel diameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vessel density</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will determine vessel density per 10 x field.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood flow velocity of the tumor vessels</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will assess the ability to measure the blood flow velocity of the tumor vessels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue penetration of fluorescein</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Fallopian Tube Carcinoma</condition>
  <condition>Primary Peritoneal Carcinoma</condition>
  <condition>Stage I Ovarian Cancer</condition>
  <condition>Stage IA Ovarian Cancer</condition>
  <condition>Stage IB Ovarian Cancer</condition>
  <condition>Stage IC Ovarian Cancer</condition>
  <condition>Stage II Ovarian Cancer</condition>
  <condition>Stage IIA Ovarian Cancer</condition>
  <condition>Stage IIB Ovarian Cancer</condition>
  <condition>Stage IIC Ovarian Cancer</condition>
  <condition>Stage III Ovarian Cancer</condition>
  <condition>Stage IIIA Ovarian Cancer</condition>
  <condition>Stage IIIB Ovarian Cancer</condition>
  <condition>Stage IIIC Ovarian Cancer</condition>
  <condition>Stage IV Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Diagnostic (intravital microscopy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diagnostic Microscopy</intervention_name>
    <description>Undergo observation via intravital microscopy</description>
    <arm_group_label>Diagnostic (intravital microscopy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorescein Sodium Injection</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (intravital microscopy)</arm_group_label>
    <other_name>AK-Fluor</other_name>
    <other_name>Fluorescite</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Diagnostic (intravital microscopy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of =&lt; 2&#xD;
&#xD;
          -  Suspicion of gynecological malignancy that requires a standard of care surgical&#xD;
             resection in the operating room;&#xD;
&#xD;
          -  Have measurable lesion in the pelvis or abdomen, at a minimum of 0.5 cm in diameter on&#xD;
             standard of care pre operative imaging studies (CT, MRI or PET scan),&#xD;
&#xD;
          -  Subject or legal representative must understand the investigational nature of this&#xD;
             study and sign an Independent Ethics Committee/Institutional Review Board approved&#xD;
             written informed consent form prior to receiving any study related procedure&#xD;
&#xD;
          -  Serum Creatinine &lt;= 1.5 X upper limit of normal (ULN) OR measured or calculated&#xD;
             creatinine clearance ≥ 60 mL/min for participant with creatinine levels &gt; 1.5 X&#xD;
             institutional ULN (using Cockcroft-Gault Equation), GFR can also be used in place of&#xD;
             creatinine or CrCl.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Any known allergy or prior reaction to fluorescein&#xD;
&#xD;
          -  Nursing female subjects&#xD;
&#xD;
          -  Liver dysfunction; normal liver function defined as total bilirubin within normal&#xD;
             institutional limits and aspartate aminotransferase (AST) (serum glutamic-oxaloacetic&#xD;
             transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate&#xD;
             transaminase [SGPT]) =&lt; 2.5 X institutional upper limit of normal&#xD;
&#xD;
          -  Any condition which in the Investigator's opinion deems the subject an unsuitable&#xD;
             candidate to undergo observational study (may also include preoperative testing&#xD;
             results including electrocardiography (EKG), chest x-ray, or pulmonary function tests&#xD;
             that preclude a wide excision in the operating room)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emese Zsiros, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03297489
org study id: I 43717
secondary id: NCI-2017-01459
secondary id: I 43717
nct id: NCT03297489
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Fluorescein within the tumor vessels
time frame: Up to 2 years
description: Will visualize fluorescein within the tumor vessels.
measure: Identification of tumor vessels
time frame: Up to 2 years
description: Will identify tumor vessels.
measure: Tumor vessel diameter
time frame: Up to 2 years
description: Will measure tumor vessel diameters.
measure: Vessel density
time frame: Up to 2 years
description: Will determine vessel density per 10 x field.
measure: Blood flow velocity of the tumor vessels
time frame: Up to 2 years
description: Will assess the ability to measure the blood flow velocity of the tumor vessels.
measure: Tissue penetration of fluorescein
time frame: Up to 2 years
description: Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability.
arm group label: Diagnostic (intravital microscopy)
arm group type: Experimental
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.
intervention type: Procedure
intervention name: Diagnostic Microscopy
description: Undergo observation via intravital microscopy
arm group label: Diagnostic (intravital microscopy)
intervention type: Drug
intervention name: Fluorescein Sodium Injection
description: Given IV
arm group label: Diagnostic (intravital microscopy)
other name: AK-Fluor
other name: Fluorescite
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Diagnostic (intravital microscopy)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emese Zsiros, MD
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial