<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/NCT01689714</url>
  </required_header>
  <id_info>
    <org_study_id>EC20.4</org_study_id>
    <nct_id>NCT01689714</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma</brief_title>
  <official_title>A MULTI-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FOLATESCAN (TECHNETIUM Tc 99m EC20) IN PATIENTS WITH SUSPECTED OVARIAN CARCINOMA OR RECURRENT ENDOMETRIAL CARCINOMA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endocyte</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endocyte</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The folate receptor is overexpressed in many types of cancer, including ovarian and&#xD;
      endometrial cancer, and the level of folate receptor expression increases with the stage of&#xD;
      the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic&#xD;
      radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide&#xD;
      an effective method to determine folate receptor-positive (FR+) target tumors, thereby&#xD;
      assisting in the identification of those patients who may benefit from folate-targeted&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study&#xD;
      was conducted to:&#xD;
&#xD;
        -  Expand the safety database and gather data on the percentage of patients with known or&#xD;
           suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake&#xD;
           of FolateScan in tumors (primary objective).&#xD;
&#xD;
        -  Calculate the sensitivity, specificity, accuracy, positive predictive value, and&#xD;
           negative predictive value of FolateScan compared with immunohistochemical (IHC) staining&#xD;
           (secondary objective).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2003</start_date>
  <completion_date type="Actual">August 2005</completion_date>
  <phase>Phase 2</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">16</enrollment>
  <condition>Ovarian Carcinoma</condition>
  <condition>Recurrent Endometrial Carcinoma</condition>
  <arm_group>
    <arm_group_label>Tc 99m EC20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received 2 intravenous (IV) injections: 1 mg of folic acid (to reduce the uptake of FolateScan in normal tissues), followed 1 to 3 minutes later by 0.1 mg of EC20 labeled with 15 to 25 mCi of technetium-99m (99mTc) over 30 seconds in a total injection volume of 1 to 2 mL.2 Each injection was given as a slow IV push via a free-flowing indwelling IV catheter in an upper extremity vein (i.e., in the antecubital fossa).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tc 99m EC20</intervention_name>
    <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. Subject must be 18 years of age or older.&#xD;
&#xD;
               2. Subject must have known or strongly suspected ovarian carcinoma or recurrent&#xD;
                  endometrial carcinoma with at least one identifiable lesion &gt; 1.5 cm as diagnosed&#xD;
                  by ultrasonography, MRI, or CT.&#xD;
&#xD;
               3. Subject must have good kidney function.&#xD;
&#xD;
               4. Subject must provide written informed consent prior to enrollment.&#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 breastfeeding.&#xD;
&#xD;
               2. Subject is simultaneously participating in another investigational 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>Val J Lowe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 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 Carcinoma</keyword>
  <keyword>Recurrent Endometrial Carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Recurrence</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/NCT01689714
org study id: EC20.4
nct id: NCT01689714
lead sponsor: 
has dmc: Yes
The folate receptor is overexpressed in many types of cancer, including ovarian and
      endometrial cancer, and the level of folate receptor expression increases with the stage of
      the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic
      radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide
      an effective method to determine folate receptor-positive (FR+) target tumors, thereby
      assisting in the identification of those patients who may benefit from folate-targeted
      therapy.
This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study
      was conducted to:

        -  Expand the safety database and gather data on the percentage of patients with known or
           suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake
           of FolateScan in tumors (primary objective).

        -  Calculate the sensitivity, specificity, accuracy, positive predictive value, and
           negative predictive value of FolateScan compared with immunohistochemical (IHC) staining
           (secondary objective).
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: Patients received 2 intravenous (IV) injections: 1 mg of folic acid (to reduce the uptake of FolateScan in normal tissues), followed 1 to 3 minutes later by 0.1 mg of EC20 labeled with 15 to 25 mCi of technetium-99m (99mTc) over 30 seconds in a total injection volume of 1 to 2 mL.2 Each injection was given as a slow IV push via a free-flowing indwelling IV catheter in an upper extremity vein (i.e., in the antecubital fossa).
intervention type: Drug
intervention name: 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: Val J Lowe, MD
role: Principal Investigator
affiliation: Mayo Clinic
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Endometrial Neoplasms
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Recurrence
mesh term: Technetium Tc 99m-ethylenedicysteine