<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/NCT03811899</url>
  </required_header>
  <id_info>
    <org_study_id>18-6241</org_study_id>
    <nct_id>NCT03811899</nct_id>
  </id_info>
  <brief_title>18F-DCFPyL PET/CT in High-grade Epithelial Ovarian Cancer (PET HOC)</brief_title>
  <official_title>18F-DCFPyL PET/CT in High-grade Epithelial Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether high grade epithelial ovarian cancers (=HG&#xD;
      EOC) are 18F-DCFPyL&#xD;
      (=2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic&#xD;
      acid)-avid and to compare the performance of this PET to CT and findings at time of surgery&#xD;
&#xD;
      Background:&#xD;
&#xD;
      There is a need for better noninvasive tools that will map disease extent in HG EOC. A recent&#xD;
      study has shown that at immunohistochemistry GCP=II is overexpressed in ovarian cancer&#xD;
      tumors, both primary and metastatic. Glucose carboxypeptidase-II (=GCP-II), also known as&#xD;
      prostate specific membrane antigen (= PSMA) has been used clinically to assess patients with&#xD;
      prostate cancer and many other tumors have been shown to be PSMA-avid on PET (including renal&#xD;
      cell carcinomas).&#xD;
&#xD;
      18F-DCFPyL has the potential to improve patient selection for primary therapy. If successful,&#xD;
      this may decrease the rate of futile surgeries and associated morbidity and better direct&#xD;
      patients to the most appropriate therapy primary debulking surgery (PDS) vs neoadjuvant&#xD;
      chemotherapy (NACT). Furthermore, if high-level GCP-II expression is shown at preoperative&#xD;
      imaging in patients with HG EOC, this may be used in considering feasibility of future&#xD;
      theranostic applications.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      This is a single arm pilot study to assess whether HG EOC are 18F-DCFPyL-avid.&#xD;
&#xD;
      In this prospective trial, the investigators will recruit 20 women whom will undergo&#xD;
      conventional staging with contrast-enhanced CT of the abdomen and pelvis as per standard of&#xD;
      care. All disease sites, primary and metastatic will be recorded using a standardized&#xD;
      reporting template.&#xD;
&#xD;
      Subsequently, 18F-DCFPyL-PET/CT will be performed (within 6 weeks of CT).&#xD;
&#xD;
      All disease sites on PET will be recorded using same reporting template in addition to&#xD;
      qualitative and semiquantitative evaluation (SUV measurement) of all known tumor sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with ovarian cancer, identifying the volume and exact locations of disease is of&#xD;
      paramount importance prior to deciding on upfront surgery versus chemotherapy. Currently,&#xD;
      most clinicians use CT scans to determine the extent of disease; however, this tool has&#xD;
      limited sensitivity and specificity. 18F-Fluorodeoxyglucose (=FDG) PET scans have been&#xD;
      previously assessed with only limited success; therefore, FDG PET scans have not been&#xD;
      universally incorporated into the workup of patients with ovarian cancer. A further&#xD;
      noninvasive tool that would accurately map disease extent is needed to better select therapy&#xD;
      for ovarian cancer patients, reduce the rate of aborted surgery and associated complications,&#xD;
      and hopefully improve overall outcome.&#xD;
&#xD;
      &quot;Glutamate carboxypeptidase II (GCP-II)&quot; is a type of an enzyme on the surface of cells. It&#xD;
      has additional names including prostate specific membrane antigen (PSMA). It is expressed by&#xD;
      normal tissues such as salivary glands, as well as by multiple malignant tumors, often in the&#xD;
      abnormal blood vessels of these tumors. A recent study has examined the expression of this&#xD;
      enzyme in gynecologic cancers including primary and metastatic ovarian cancer. The authors&#xD;
      showed a high expression of this enzyme at special staining performed on surgical tumor&#xD;
      samples. In other cancers, such as prostate cancer PET with GCP-II (=PSMA PET) has shown very&#xD;
      high sensitivity and high specificity for the detection of tumor sites, even when CT is&#xD;
      negative. In this study the investigators will be assessing the performance of this special&#xD;
      PET scan using a PSMA tracer called &quot;18F-DCFPyL&quot;. The investigators will investigate the&#xD;
      ability of 18F-DCFPyL PET scans to detect sites of disease in patients with ovarian cancer.&#xD;
      Disease sites seen on PET will be compared to what is seen on the standard CT scan, and to&#xD;
      what is found at time of surgery (if surgery is performed).&#xD;
&#xD;
      The rationale for this study is that there is a need for better noninvasive tools that will&#xD;
      map disease extent in HG EOC. A recent study has shown that at immunohistochemistry GCP=II is&#xD;
      overexpressed in ovarian cancer tumors, both primary and metastatic. GCP-II (=PSMA) has been&#xD;
      used clinically to assess patients with prostate cancer and many other tumours have been&#xD;
      shown to be PSMA-avid on PET (including renal cell carcinomas). The purpose of this study is&#xD;
      to determine whether HG SOC are 18F-DCFPyL (=GCP-II)-avid and to compare the performance of&#xD;
      this PET to CT and findings at time of surgery.&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
      To determine whether HG EOCs are 18F-DCFPyL avid on PET/CT.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To compare the sites of disease identified on PET/CT to contrast-enhanced CT (standard of&#xD;
      care).&#xD;
&#xD;
      To determine whether there is heterogeneity in 18F-DCFPyL-avidity at different tumor sites.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">October 13, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Single arm study to determine whether HG EOC are 18F-DCFPyL-avid.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>18F-DCFPyL-avid PET/CT</measure>
    <time_frame>Through study completion up to 2 years</time_frame>
    <description>To determine the proportion of HG EOC that are18F-DCFPyL-avid on PET/CT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>18F-DCFPyL PET/CT vs. Contrast-enhanced CT</measure>
    <time_frame>Through study completion up to 2 years</time_frame>
    <description>The determine the proportion of HG EOC tumor sites detected on 18F-DCFPyL PET/CT compared to contrast-enhanced CT</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Stage III Ovarian Cancer</condition>
  <condition>Stage IV Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>18F-DCFPyL PET/CT imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will use technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data is gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>18F-DCFPyL</intervention_name>
    <description>The purpose of this study is to determine whether HG SOC are 18F-DCFPyL (=GCP-II)-avid and to compare the performance of this PET to CT and findings at time of surgery.</description>
    <arm_group_label>18F-DCFPyL PET/CT imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Cytological or histological diagnosis of high grade epithelial ovarian cancer, or&#xD;
             clinical suspicious of HG EOC based on symptoms, physical exam, tumor markers and&#xD;
             imaging findings.&#xD;
&#xD;
          -  Clinical stage III or IV, being considered for primary debulking surgery or NACT.&#xD;
&#xD;
          -  Contrast-enhanced CT abdomen and pelvis within 6 weeks of PET (prior to enrollment).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent.&#xD;
&#xD;
          -  Contraindication for PET examination as per institutional safety guidelines, including&#xD;
             but not limited to pregnancy, or inability to lie still for PET examination.&#xD;
&#xD;
          -  Evidence of the following epithelial ovarian cancer histological subtypes: Mucinous,&#xD;
             low grade serous, low grade endometrioid and low-malignant potential tumors.&#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>Ur Metser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UHN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</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>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03811899
org study id: 18-6241
nct id: NCT03811899
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether high grade epithelial ovarian cancers (=HG
      EOC) are 18F-DCFPyL
      (=2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic
      acid)-avid and to compare the performance of this PET to CT and findings at time of surgery

      Background:

      There is a need for better noninvasive tools that will map disease extent in HG EOC. A recent
      study has shown that at immunohistochemistry GCP=II is overexpressed in ovarian cancer
      tumors, both primary and metastatic. Glucose carboxypeptidase-II (=GCP-II), also known as
      prostate specific membrane antigen (= PSMA) has been used clinically to assess patients with
      prostate cancer and many other tumors have been shown to be PSMA-avid on PET (including renal
      cell carcinomas).

      18F-DCFPyL has the potential to improve patient selection for primary therapy. If successful,
      this may decrease the rate of futile surgeries and associated morbidity and better direct
      patients to the most appropriate therapy primary debulking surgery (PDS) vs neoadjuvant
      chemotherapy (NACT). Furthermore, if high-level GCP-II expression is shown at preoperative
      imaging in patients with HG EOC, this may be used in considering feasibility of future
      theranostic applications.

      Study Design:

      This is a single arm pilot study to assess whether HG EOC are 18F-DCFPyL-avid.

      In this prospective trial, the investigators will recruit 20 women whom will undergo
      conventional staging with contrast-enhanced CT of the abdomen and pelvis as per standard of
      care. All disease sites, primary and metastatic will be recorded using a standardized
      reporting template.

      Subsequently, 18F-DCFPyL-PET/CT will be performed (within 6 weeks of CT).

      All disease sites on PET will be recorded using same reporting template in addition to
      qualitative and semiquantitative evaluation (SUV measurement) of all known tumor sites.
In patients with ovarian cancer, identifying the volume and exact locations of disease is of
      paramount importance prior to deciding on upfront surgery versus chemotherapy. Currently,
      most clinicians use CT scans to determine the extent of disease; however, this tool has
      limited sensitivity and specificity. 18F-Fluorodeoxyglucose (=FDG) PET scans have been
      previously assessed with only limited success; therefore, FDG PET scans have not been
      universally incorporated into the workup of patients with ovarian cancer. A further
      noninvasive tool that would accurately map disease extent is needed to better select therapy
      for ovarian cancer patients, reduce the rate of aborted surgery and associated complications,
      and hopefully improve overall outcome.

      "Glutamate carboxypeptidase II (GCP-II)" is a type of an enzyme on the surface of cells. It
      has additional names including prostate specific membrane antigen (PSMA). It is expressed by
      normal tissues such as salivary glands, as well as by multiple malignant tumors, often in the
      abnormal blood vessels of these tumors. A recent study has examined the expression of this
      enzyme in gynecologic cancers including primary and metastatic ovarian cancer. The authors
      showed a high expression of this enzyme at special staining performed on surgical tumor
      samples. In other cancers, such as prostate cancer PET with GCP-II (=PSMA PET) has shown very
      high sensitivity and high specificity for the detection of tumor sites, even when CT is
      negative. In this study the investigators will be assessing the performance of this special
      PET scan using a PSMA tracer called "18F-DCFPyL". The investigators will investigate the
      ability of 18F-DCFPyL PET scans to detect sites of disease in patients with ovarian cancer.
      Disease sites seen on PET will be compared to what is seen on the standard CT scan, and to
      what is found at time of surgery (if surgery is performed).

      The rationale for this study is that there is a need for better noninvasive tools that will
      map disease extent in HG EOC. A recent study has shown that at immunohistochemistry GCP=II is
      overexpressed in ovarian cancer tumors, both primary and metastatic. GCP-II (=PSMA) has been
      used clinically to assess patients with prostate cancer and many other tumours have been
      shown to be PSMA-avid on PET (including renal cell carcinomas). The purpose of this study is
      to determine whether HG SOC are 18F-DCFPyL (=GCP-II)-avid and to compare the performance of
      this PET to CT and findings at time of surgery.

      Primary Objective

      To determine whether HG EOCs are 18F-DCFPyL avid on PET/CT.

      Secondary Objectives:

      To compare the sites of disease identified on PET/CT to contrast-enhanced CT (standard of
      care).

      To determine whether there is heterogeneity in 18F-DCFPyL-avidity at different tumor sites.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single arm study to determine whether HG EOC are 18F-DCFPyL-avid.
primary purpose: Diagnostic
masking: None (Open Label)
measure: 18F-DCFPyL-avid PET/CT
time frame: Through study completion up to 2 years
description: To determine the proportion of HG EOC that are18F-DCFPyL-avid on PET/CT.
measure: 18F-DCFPyL PET/CT vs. Contrast-enhanced CT
time frame: Through study completion up to 2 years
description: The determine the proportion of HG EOC tumor sites detected on 18F-DCFPyL PET/CT compared to contrast-enhanced CT
arm group label: 18F-DCFPyL PET/CT imaging
arm group type: Experimental
description: We will use technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data is gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.
intervention type: Diagnostic Test
intervention name: 18F-DCFPyL
description: The purpose of this study is to determine whether HG SOC are 18F-DCFPyL (=GCP-II)-avid and to compare the performance of this PET to CT and findings at time of surgery.
arm group label: 18F-DCFPyL PET/CT imaging
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ur Metser, MD
role: Principal Investigator
affiliation: UHN
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: Undecided