<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/NCT01686256</url>
  </required_header>
  <id_info>
    <org_study_id>EC20.2</org_study_id>
    <nct_id>NCT01686256</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer</brief_title>
  <official_title>A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endocyte</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endocyte</source>
  <brief_summary>
    <textblock>
      A Multi-Center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium&#xD;
      Tc 99m EC20) in Women with Suspected Ovarian or Endometrial Cancer.&#xD;
&#xD;
      Phase I - The proposed indication for FolateScan is disease or pathological assessment of&#xD;
      ovarian or endometrial masses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed to verify product safety, determine optimal imaging time, gather&#xD;
      efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses for&#xD;
      presence of folate receptors, in women with suspected ovarian or endometrial cancer. Twelve&#xD;
      subjects will be enrolled, with a minimum of five malignant cases, as determined by&#xD;
      histopathological evaluation.&#xD;
&#xD;
      Women with a suspected ovarian or endometrial mass who either 1) have fixed, paraffin&#xD;
      embedded tissue sample(s) available for immunohistochemical staining obtained from a previous&#xD;
      pathological evaluation or 2) are scheduled for a procedure to obtain tissue for pathological&#xD;
      evaluation that can be fixed and paraffin embedded for immunohistochemical staining are&#xD;
      eligible for this study. The ovarian mass may be either an initial finding, e.g., found at a&#xD;
      routine pelvic examination or to investigate symptoms, or the ovarian or endometrial mass may&#xD;
      be a finding suspicious of recurrent or residual tumor at follow-up examination after&#xD;
      surgical resection of confirmed ovarian or endometrial cancer. Patients may not be pregnant&#xD;
      or breastfeeding at enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2001</start_date>
  <primary_completion_date type="Actual">August 2004</primary_completion_date>
  <phase>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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Tc 99m EC20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A Phase 1, multi-center, open-label, single-treatment group, baseline-controlled (for safety) study designed to verify product safety, determine optimal imaging time, gather efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses for presence of folate receptors, in women with suspected ovarian or endometrial cancer. Twelve subjects will be enrolled, with a minimum of five malignant cases, as determined by histopathological evaluation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tc 99m EC20</intervention_name>
    <description>Each subject will receive 1 mg of folic acid injected 1-3 minutes prior to administration of Technetium Tc 99m EC20.</description>
    <arm_group_label>Tc 99m EC20</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must meet the following eligibility requirements to be enrolled in the study.&#xD;
&#xD;
               1. Subjects must be female, 18 years of age or older.&#xD;
&#xD;
               2. Subjects must have suspected ovarian cancer or metastatic or recurrent ovarian or&#xD;
                  endometrial cancer with a known pelvic mass as diagnosed by ultrasound, MRI, or&#xD;
                  CT.&#xD;
&#xD;
               3. Subjects either are scheduled to undergo a procedure to obtain tissue for&#xD;
                  pathological evaluation that can be fixed and paraffin embedded for&#xD;
                  immunohistochemical staining or have sufficient amounts of fixed, paraffin&#xD;
                  embedded tissue sample(s) available for immunohistochemical staining obtained&#xD;
                  from a previous pathological evaluation.&#xD;
&#xD;
               4. Subjects must provide written informed consent prior to enrollment.&#xD;
&#xD;
               5. Subjects must have kidney function with a creatinine value &lt;2.0 mg/dL (within the&#xD;
                  previous 30 days).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects must be excluded if any of the following conditions are present:&#xD;
&#xD;
               1. Subject is pregnant or breast-feeding.&#xD;
&#xD;
               2. Subject is simultaneously participating in another investigative drug study.&#xD;
&#xD;
               3. Subject has completed the follow-up phase of any previous study less than 30 days&#xD;
                  prior to enrollment in this study.&#xD;
&#xD;
               4. Subject is unable to tolerate conditions for radionuclide imaging.&#xD;
&#xD;
               5. Subject has been administered another radiopharmaceutical that would interfere&#xD;
                  with the assessment of Technetium Tc 99m EC20.&#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>James W. Fletcher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Medical Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian Cancer</keyword>
  <keyword>Endometrial Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Technetium Tc 99m-ethylenedicysteine</mesh_term>
  </intervention_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/NCT01686256
org study id: EC20.2
nct id: NCT01686256
lead sponsor: 
A Multi-Center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium
      Tc 99m EC20) in Women with Suspected Ovarian or Endometrial Cancer.

      Phase I - The proposed indication for FolateScan is disease or pathological assessment of
      ovarian or endometrial masses.
The study is designed to verify product safety, determine optimal imaging time, gather
      efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses for
      presence of folate receptors, in women with suspected ovarian or endometrial cancer. Twelve
      subjects will be enrolled, with a minimum of five malignant cases, as determined by
      histopathological evaluation.

      Women with a suspected ovarian or endometrial mass who either 1) have fixed, paraffin
      embedded tissue sample(s) available for immunohistochemical staining obtained from a previous
      pathological evaluation or 2) are scheduled for a procedure to obtain tissue for pathological
      evaluation that can be fixed and paraffin embedded for immunohistochemical staining are
      eligible for this study. The ovarian mass may be either an initial finding, e.g., found at a
      routine pelvic examination or to investigate symptoms, or the ovarian or endometrial mass may
      be a finding suspicious of recurrent or residual tumor at follow-up examination after
      surgical resection of confirmed ovarian or endometrial cancer. Patients may not be pregnant
      or breastfeeding at enrollment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
arm group label: Tc 99m EC20
arm group type: Experimental
description: A Phase 1, multi-center, open-label, single-treatment group, baseline-controlled (for safety) study designed to verify product safety, determine optimal imaging time, gather efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses for presence of folate receptors, in women with suspected ovarian or endometrial cancer. Twelve subjects will be enrolled, with a minimum of five malignant cases, as determined by histopathological evaluation.
intervention type: Drug
intervention name: Tc 99m EC20
description: Each subject will receive 1 mg of folic acid injected 1-3 minutes prior to administration of Technetium Tc 99m EC20.
arm group label: Tc 99m EC20
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James W. Fletcher, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Endometrial Neoplasms
mesh term: Technetium Tc 99m-ethylenedicysteine