<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/NCT03302156</url>
  </required_header>
  <id_info>
    <org_study_id>UW17017</org_study_id>
    <secondary_id>2017-0456</secondary_id>
    <secondary_id>A539300</secondary_id>
    <secondary_id>SMPH\RADIOLOGY\RADIOLOGY</secondary_id>
    <secondary_id>NCI-2018-00466</secondary_id>
    <secondary_id>06-08-2020</secondary_id>
    <nct_id>NCT03302156</nct_id>
  </id_info>
  <brief_title>PSMA PET and MRI in Gynecological Cancers</brief_title>
  <official_title>PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</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>
      The goal of this research is to determine the accuracy of PSMA positron emission tomography&#xD;
      (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of&#xD;
      gynecological cancer cells in the body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will evaluate a novel second-generation low-molecular-weight prostate&#xD;
      specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL,&#xD;
      to determine the presence or absence of cancer, the accurate distribution of cancer and the&#xD;
      normal biodistribution of PSMA in the abdomen and pelvis on PET imaging.&#xD;
&#xD;
      PSMA, also known as folate hydrolase 1 and glutamate carboxypeptidase II, is an enzyme&#xD;
      associated with prostate cancer but has been also found to be expressed in the tumor&#xD;
      neovasculature of many different types of non-prostate cancer tumors. PSMA-based 18F-DCFPyL&#xD;
      PET demonstrates very high tumor-to-background ratio when studied in other tumors, including&#xD;
      prostate tumors.&#xD;
&#xD;
      MR imaging is a highly sensitive and specific imaging modality that can be used for&#xD;
      gynecologic cancers. MR images can be obtained in conjunction with PSMA PET, adding&#xD;
      additional anatomic and multi-parametric MRI information without the need for a second&#xD;
      imaging appointment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual following suspension per COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Actual">January 20, 2020</completion_date>
  <primary_completion_date type="Actual">January 20, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Accuracy</measure>
    <time_frame>up to 1 day</time_frame>
    <description>Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biodistribution of PSMA Measured by SUVmax in Normal Tissue</measure>
    <time_frame>up to 1 day</time_frame>
    <description>Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biodistribution of PSMA Measured by SUVmax in Cancer Tissue</measure>
    <time_frame>up to 1 day</time_frame>
    <description>Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiodosimetry of PSMA</measure>
    <time_frame>up to 1 day</time_frame>
    <description>The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and Specificity of PSMA-based PET/MR</measure>
    <time_frame>up to 1 day</time_frame>
    <description>Record the distribution of PSMA in cancer tissue.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Gynecologic Cancer</condition>
  <arm_group>
    <arm_group_label>Healthy Control Non-Dosimetry Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dosimetry Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PSMA-based 18F-DCFPyL PET tracer</intervention_name>
    <description>PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
    <arm_group_label>Dosimetry Group</arm_group_label>
    <arm_group_label>Healthy Control Non-Dosimetry Group</arm_group_label>
    <arm_group_label>Patient Group</arm_group_label>
    <other_name>PSMA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for healthy female controls N=12 (includes up to 6 Dosimetry&#xD;
        participants):&#xD;
&#xD;
          -  Women with no suspected gynecological cancer.&#xD;
&#xD;
          -  No contraindications for MR or PET imaging.&#xD;
&#xD;
          -  Greater than or equal to 18 years of age.&#xD;
&#xD;
          -  Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy&#xD;
&#xD;
        Inclusion Criteria for female controls (Dosimetry):&#xD;
&#xD;
          -  Women with or without suspected gynecological cancer.&#xD;
&#xD;
          -  No contraindications for MR or PET imaging.&#xD;
&#xD;
          -  Greater than or equal to 18 years of age.&#xD;
&#xD;
        Inclusion Criteria for gynecological cancer patients (N=40):&#xD;
&#xD;
          -  Women with known or suspected gynecological cancer&#xD;
&#xD;
          -  No contraindications for MR or PET imaging.&#xD;
&#xD;
          -  Greater than or equal to 18 years&#xD;
&#xD;
          -  Have had or are scheduled to undergo a hysterectomy and/or salpingo-oophorectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women that are pregnant or breast-feeding.&#xD;
&#xD;
          -  Age &lt;18&#xD;
&#xD;
          -  Inability to provide informed consent on their own behalf&#xD;
&#xD;
          -  Severe kidney dysfunction (GFR &lt;30 mL/min/1.73m2)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steve Cho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Sadowski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin, Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cancer.wisc.edu/</url>
    <description>University of Wisconsin Carbone Cancer Center</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>May 10, 2023</results_first_submitted>
  <results_first_submitted_qc>July 19, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 9, 2023</results_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Uterine cancer</keyword>
  <keyword>Ovarian cancer</keyword>
  <keyword>Hysterectomy</keyword>
  <keyword>Salpingo-oophorectomy</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03302156/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>15 participants were consented from November 2017 to December 2019. Research was suspended in March 2020 per the COVID-19 pandemic. The study opened to enrollment again in June 2022; there were no more participants consented. The investigator terminated the study in January 2023 due to slow accrual of patients with ovarian cancer and due to lack of funding. No participants were enrolled in the Dosimetry group.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Healthy Control Non-Dosimetry Group</title>
          <description>The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
        </group>
        <group group_id="P2">
          <title>Patient Group</title>
          <description>The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
        </group>
        <group group_id="P3">
          <title>Dosimetry Group</title>
          <description>Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Analysis Population</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants With Confirmed Ovarian Cancer With PSMA Uptake</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>no visible evidence of tumor on MRI</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>study terminated early, no participants enrolled in dosimetry group</population>
      <group_list>
        <group group_id="B1">
          <title>Healthy Control Non-Dosimetry Group</title>
          <description>The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
        </group>
        <group group_id="B2">
          <title>Patient Group</title>
          <description>The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.5" lower_limit="39" upper_limit="68"/>
                    <measurement group_id="B2" value="57.3" lower_limit="36" upper_limit="86"/>
                    <measurement group_id="B3" value="56.7" lower_limit="36" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Suspected Participant Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Healthy Controls</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ovarian Cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Endometrial Cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cervical Cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other Cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Diagnostic Accuracy</title>
        <description>Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.</description>
        <time_frame>up to 1 day</time_frame>
        <population>Calculating accuracy relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control Non-Dosimetry Group</title>
            <description>The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O2">
            <title>Patient Group</title>
            <description>The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O3">
            <title>Dosimetry Group</title>
            <description>Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Diagnostic Accuracy</title>
          <description>Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.</description>
          <population>Calculating accuracy relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biodistribution of PSMA Measured by SUVmax in Normal Tissue</title>
        <description>Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.</description>
        <time_frame>up to 1 day</time_frame>
        <population>This was performed on the entire population of patients recruited in both the Healthy Control and Patient group.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control Non-Dosimetry Group</title>
            <description>The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O2">
            <title>Patient Group</title>
            <description>The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O3">
            <title>Dosimetry Group</title>
            <description>Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Biodistribution of PSMA Measured by SUVmax in Normal Tissue</title>
          <description>Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.</description>
          <population>This was performed on the entire population of patients recruited in both the Healthy Control and Patient group.</population>
          <units>SUVmax</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Aorta at carina</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.1"/>
                    <measurement group_id="O2" value="1.7" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Liver - Right Lobe</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" spread="5.4"/>
                    <measurement group_id="O2" value="10.0" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myometrium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.4"/>
                    <measurement group_id="O2" value="2.9" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="1.8"/>
                    <measurement group_id="O2" value="4.8" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cervix</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="1.1"/>
                    <measurement group_id="O2" value="3.3" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right Ovary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.7"/>
                    <measurement group_id="O2" value="3.0" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corpus Luteum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="NA">Standard deviation was not calculated as only a single participant was analyzed</measurement>
                    <measurement group_id="O2" value="5.9" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Ovary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.4"/>
                    <measurement group_id="O2" value="2.3" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biodistribution of PSMA Measured by SUVmax in Cancer Tissue</title>
        <description>Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.</description>
        <time_frame>up to 1 day</time_frame>
        <population>This was performed on the &quot;Patient&quot; population. There was only one patient with confirmed ovarian cancer with PSMA uptake.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control Non-Dosimetry Group</title>
            <description>The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O2">
            <title>Patient Group</title>
            <description>The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O3">
            <title>Dosimetry Group</title>
            <description>Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Biodistribution of PSMA Measured by SUVmax in Cancer Tissue</title>
          <description>Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.</description>
          <population>This was performed on the &quot;Patient&quot; population. There was only one patient with confirmed ovarian cancer with PSMA uptake.</population>
          <units>SUVmax</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="10.5" spread="NA">Standard deviation was not calculated as only a single participant was analyzed</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiodosimetry of PSMA</title>
        <description>The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.</description>
        <time_frame>up to 1 day</time_frame>
        <population>No data was collected for this. There were no participants enrolled into the Dosimetry group. The study was terminated early due to low accrual and loss of funding.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control Non-Dosimetry Group</title>
            <description>The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O2">
            <title>Patient Group</title>
            <description>The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O3">
            <title>Dosimetry Group</title>
            <description>Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Radiodosimetry of PSMA</title>
          <description>The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.</description>
          <population>No data was collected for this. There were no participants enrolled into the Dosimetry group. The study was terminated early due to low accrual and loss of funding.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensitivity and Specificity of PSMA-based PET/MR</title>
        <description>Record the distribution of PSMA in cancer tissue.</description>
        <time_frame>up to 1 day</time_frame>
        <population>Calculating sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control Non-Dosimetry Group</title>
            <description>The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O2">
            <title>Patient Group</title>
            <description>The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
          <group group_id="O3">
            <title>Dosimetry Group</title>
            <description>Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity and Specificity of PSMA-based PET/MR</title>
          <description>Record the distribution of PSMA in cancer tissue.</description>
          <population>Calculating sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>during research visit, up to 3 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Healthy Control Non-Dosimetry Group</title>
          <description>The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
        </group>
        <group group_id="E2">
          <title>Patient Group</title>
          <description>The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40&#xD;
PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Calculating accuracy, sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Elizabeth Sadowski, MD</name_or_title>
      <organization>UW School of Medicine and Public Health</organization>
      <phone>608-263-9028</phone>
      <email>esadowski@uwhealth.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03302156
org study id: UW17017
secondary id: 2017-0456
secondary id: A539300
secondary id: SMPH\RADIOLOGY\RADIOLOGY
secondary id: NCI-2018-00466
secondary id: 06-08-2020
nct id: NCT03302156
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The goal of this research is to determine the accuracy of PSMA positron emission tomography
      (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of
      gynecological cancer cells in the body.
The investigators will evaluate a novel second-generation low-molecular-weight prostate
      specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL,
      to determine the presence or absence of cancer, the accurate distribution of cancer and the
      normal biodistribution of PSMA in the abdomen and pelvis on PET imaging.

      PSMA, also known as folate hydrolase 1 and glutamate carboxypeptidase II, is an enzyme
      associated with prostate cancer but has been also found to be expressed in the tumor
      neovasculature of many different types of non-prostate cancer tumors. PSMA-based 18F-DCFPyL
      PET demonstrates very high tumor-to-background ratio when studied in other tumors, including
      prostate tumors.

      MR imaging is a highly sensitive and specific imaging modality that can be used for
      gynecologic cancers. MR images can be obtained in conjunction with PSMA PET, adding
      additional anatomic and multi-parametric MRI information without the need for a second
      imaging appointment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic Accuracy
time frame: up to 1 day
description: Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.
measure: Biodistribution of PSMA Measured by SUVmax in Normal Tissue
time frame: up to 1 day
description: Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.
measure: Biodistribution of PSMA Measured by SUVmax in Cancer Tissue
time frame: up to 1 day
description: Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.
measure: Radiodosimetry of PSMA
time frame: up to 1 day
description: The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.
measure: Sensitivity and Specificity of PSMA-based PET/MR
time frame: up to 1 day
description: Record the distribution of PSMA in cancer tissue.
arm group label: Healthy Control Non-Dosimetry Group
arm group type: Other
description: The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6
arm group label: Patient Group
arm group type: Other
description: The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40
arm group label: Dosimetry Group
arm group type: Other
description: Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6
intervention type: Drug
intervention name: PSMA-based 18F-DCFPyL PET tracer
description: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer
arm group label: Dosimetry Group
arm group label: Healthy Control Non-Dosimetry Group
arm group label: Patient Group
other name: PSMA
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steve Cho, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Elizabeth Sadowski, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: https://cancer.wisc.edu/
description: University of Wisconsin Carbone Cancer Center
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Calculating accuracy, sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.
point of contact: 