<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/NCT01689727</url>
  </required_header>
  <id_info>
    <org_study_id>EC20.7</org_study_id>
    <nct_id>NCT01689727</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors</brief_title>
  <official_title>A Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endocyte</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endocyte</source>
  <brief_summary>
    <textblock>
      Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This&#xD;
      Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a&#xD;
      ligand (EC20) designed to bind to the folate receptor. The study is designed as an&#xD;
      open-label, baseline-controlled study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2 open-label, single-treatment group, baseline-controlled study designed to&#xD;
      verify product safety, gather data on the percentage of subjects with pituitary tumors with&#xD;
      increased uptake of FolateScan in tumors and correlate the immunohistochemical staining&#xD;
      findings with the FolateScan images, in subjects with pituitary tumors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2002</start_date>
  <primary_completion_date type="Actual">September 2004</primary_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">40</enrollment>
  <condition>Pituitary Tumors</condition>
  <arm_group>
    <arm_group_label>Technetium Tc 99m EC20</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Technetium Tc 99m EC20</intervention_name>
    <arm_group_label>Technetium 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 a pituitary tumor.&#xD;
&#xD;
          3. Subject must have good kidney function.&#xD;
&#xD;
        3. 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 loess 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 with&#xD;
             the assessment of Technetium Tc 99m EC20.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nelson Oyesiku, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</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 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>Pituitary Tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pituitary Neoplasms</mesh_term>
    <mesh_term>Pituitary Diseases</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/NCT01689727
org study id: EC20.7
nct id: NCT01689727
lead sponsor: 
Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This
      Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a
      ligand (EC20) designed to bind to the folate receptor. The study is designed as an
      open-label, baseline-controlled study.
This is a Phase 2 open-label, single-treatment group, baseline-controlled study designed to
      verify product safety, gather data on the percentage of subjects with pituitary tumors with
      increased uptake of FolateScan in tumors and correlate the immunohistochemical staining
      findings with the FolateScan images, in subjects with pituitary tumors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
arm group label: Technetium Tc 99m EC20
arm group type: Other
intervention type: Drug
intervention name: Technetium Tc 99m EC20
arm group label: Technetium Tc 99m EC20
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nelson Oyesiku, MD
role: Principal Investigator
affiliation: Emory Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pituitary Neoplasms
mesh term: Pituitary Diseases
mesh term: Technetium Tc 99m-ethylenedicysteine