<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/NCT01689662</url>
  </required_header>
  <id_info>
    <org_study_id>EC20.3</org_study_id>
    <nct_id>NCT01689662</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma</brief_title>
  <official_title>A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected 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>
      The folate receptor (FR) is overexpressed by many different cancer types, including renal&#xD;
      cell carcinoma. Besides helping in the diagnosis of cancer, a folate-targeted imaging agent&#xD;
      could provide an effective method to identify folate receptor-positive (FR+) cancer patients&#xD;
      that may benefit from folate-targeted therapy. Up to 40 subjects, with known or strongly&#xD;
      suspected metastatic renal cell carcinoma with at least one target lesion detected by a&#xD;
      diagnostic imaging procedure (e.g. ultrasonography, CT, or MRI), will be enrolled in this&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted&#xD;
      diagnostic radiopharmaceutical designed to bind to the folate receptor. The folate receptor&#xD;
      is a glycoprotein that is over-expressed in many types of cancer cells but it is only&#xD;
      minimally distributed in normal tissues. Folate conjugates bind to the folate receptor with&#xD;
      high affinity and are brought into the cell via endocytosis. In contrast, folic acid itself&#xD;
      enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to&#xD;
      folate conjugates. Therefore, these folate conjugates are specific to cancer cells.&#xD;
&#xD;
      Endocyte's folate-targeted delivery system was applied towards the targeting of a diagnostic&#xD;
      imaging agent (111In-DTPA-Folate) to ovarian cancer tumors. This proof-of-principle study was&#xD;
      designed to demonstrate the ability of folate to target drugs to folate-receptor-positive&#xD;
      (FR+) cancer tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2002</start_date>
  <completion_date type="Actual">July 2003</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>Metastatic Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Tc 99m EC20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive two intravenous injections 1-3 minutes apart:&#xD;
1 mg of folic acid&#xD;
1-2 mL injection of 0.1 mg of EC20 labeled with 15-25 mCi of technetium-99m</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 metastatic renal cell carcinoma&#xD;
                  with at least one target lesion as identified 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;
                  excluding the follow-up phase.&#xD;
&#xD;
               3. Subject has received an investigational agent within 7 days prior to enrollment.&#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>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>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>Metastatic Renal Cell Carcinoma</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/NCT01689662
org study id: EC20.3
nct id: NCT01689662
lead sponsor: 
The folate receptor (FR) is overexpressed by many different cancer types, including renal
      cell carcinoma. Besides helping in the diagnosis of cancer, a folate-targeted imaging agent
      could provide an effective method to identify folate receptor-positive (FR+) cancer patients
      that may benefit from folate-targeted therapy. Up to 40 subjects, with known or strongly
      suspected metastatic renal cell carcinoma with at least one target lesion detected by a
      diagnostic imaging procedure (e.g. ultrasonography, CT, or MRI), will be enrolled in this
      study.
The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted
      diagnostic radiopharmaceutical 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.

      Endocyte's folate-targeted delivery system was applied towards the targeting of a diagnostic
      imaging agent (111In-DTPA-Folate) to ovarian cancer tumors. This proof-of-principle study was
      designed to demonstrate the ability of folate to target drugs to folate-receptor-positive
      (FR+) cancer tissue.
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: Subjects will receive two intravenous injections 1-3 minutes apart:
1 mg of folic acid
1-2 mL injection of 0.1 mg of EC20 labeled with 15-25 mCi of technetium-99m
intervention type: Drug
intervention name: Tc 99m EC20
arm group label: Tc 99m EC20
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Technetium Tc 99m-ethylenedicysteine