<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/NCT01689766</url>
  </required_header>
  <id_info>
    <org_study_id>EC20.9</org_study_id>
    <nct_id>NCT01689766</nct_id>
  </id_info>
  <brief_title>Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma</brief_title>
  <official_title>A Screening Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endocyte</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endocyte</source>
  <brief_summary>
    <textblock>
      Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to&#xD;
      identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted&#xD;
      diagnostic radiopharmaceutical agent designed to bind to the folate receptor. The folate&#xD;
      receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is&#xD;
      only minimally distributed in normal tissues . Folate conjugates bind to the folate receptor&#xD;
      with high affinity and are brought into the cell via endocytosis. In contrast, folic acid&#xD;
      itself enters most normal cells via the reduced folate carrier, a pathway entirely&#xD;
      inaccessible to folate conjugates. Therefore, these folate conjugates are specific to cancer&#xD;
      cells.&#xD;
&#xD;
      This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled&#xD;
      study designed to verify product safety, gather data on the percentage of metastatic renal&#xD;
      cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate&#xD;
      sensitivity, specificity, accuracy, positive predictive value, and negative predictive value&#xD;
      of FolateScan compared to immunohistochemical staining (IHC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2003</start_date>
  <primary_completion_date type="Actual">November 2007</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">150</enrollment>
  <condition>Metastatic Renal Cell Carcinoma</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;
          -  To be eligible for the study, patients must fulfill all of the following criteria:&#xD;
&#xD;
               1. Patient must be 18 years of age or older.&#xD;
&#xD;
               2. Patient must have suspected metastatic renal cell carcinoma with at least one&#xD;
                  identifiable lesion &gt;2.0 cm as diagnosed by CT, MRI, or ultrasonography within 60&#xD;
                  days prior to enrollment.&#xD;
&#xD;
               3. Patient must have good kidney function defined as a serum creatinine ≤1.5 X ULN.&#xD;
&#xD;
               4. Patient must provide written informed consent prior to enrollment.&#xD;
&#xD;
               5. Patients must provide a formalin-fixed, paraffin-embedded tissue sample of either&#xD;
                  the primary or metastatic or recurrent site(s) for IHC staining for the presence&#xD;
                  of folate receptors from either a previous surgical/biopsy procedure or from a&#xD;
                  surgery/biopsy scheduled within 30 days of FolateScan. A fine needle aspirate is&#xD;
                  not acceptable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following criteria will make the patient ineligible to participate in this&#xD;
             study:&#xD;
&#xD;
               1. Patient is pregnant or breastfeeding.&#xD;
&#xD;
               2. Patient is simultaneously participating in another investigational drug study,&#xD;
                  excluding the follow-up phase.&#xD;
&#xD;
               3. Patient has received an investigational agent or therapeutic chemotherapy within&#xD;
                  7 days prior to enrollment.&#xD;
&#xD;
               4. Patient is unable to tolerate conditions for radionuclide imaging.&#xD;
&#xD;
               5. Patient has been administered another radiopharmaceutical that would interfere&#xD;
                  with 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>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</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>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal Cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</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/NCT01689766
org study id: EC20.9
nct id: NCT01689766
lead sponsor: 
Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to
      identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma
The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted
      diagnostic radiopharmaceutical agent designed to bind to the folate receptor. The folate
      receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is
      only minimally distributed in normal tissues . Folate conjugates bind to the folate receptor
      with high affinity and are brought into the cell via endocytosis. In contrast, folic acid
      itself enters most normal cells via the reduced folate carrier, a pathway entirely
      inaccessible to folate conjugates. Therefore, these folate conjugates are specific to cancer
      cells.

      This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled
      study designed to verify product safety, gather data on the percentage of metastatic renal
      cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate
      sensitivity, specificity, accuracy, positive predictive value, and negative predictive value
      of FolateScan compared to immunohistochemical staining (IHC).
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
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Technetium Tc 99m-ethylenedicysteine