<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/NCT01684098</url>
  </required_header>
  <id_info>
    <org_study_id>EC20.8</org_study_id>
    <nct_id>NCT01684098</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor</brief_title>
  <official_title>A Phase II Clinical Study to Evaluate the Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor</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 is over-expressed on many types of cancer cells and new folate receptor&#xD;
      targeted therapies are being developed to target cancer cells that over-express the folate&#xD;
      receptor. As with other targeted therapies, it is important to develop diagnostic tests that&#xD;
      will provide accurate information on folate receptor status and aid in selecting patients&#xD;
      that may benefit from folate-targeted therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase II, limited institution, open-label, single-arm, baseline-controlled study is&#xD;
      designed to obtain data on the percentage of patients with recurrent or metastatic cancer&#xD;
      from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver,&#xD;
      colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased&#xD;
      uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the&#xD;
      FolateScan images, and verify product safety in patients with suspected recurrent or&#xD;
      metastatic disease from any solid tumor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2003</start_date>
  <completion_date>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>40</enrollment>
  <condition>Recurrent or Metastatic Cancer</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Pancreas Cancer</condition>
  <condition>Bladder Cancer</condition>
  <condition>Testicular Cancer</condition>
  <arm_group>
    <arm_group_label>Tc 99m EC20</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </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;
          -  Patients must meet the following eligibility requirements to be enrolled in the study:&#xD;
&#xD;
               1. Patient must be 18 years of age or older.&#xD;
&#xD;
               2. Patient must have known or strongly suspected recurrent or metastatic cancer from&#xD;
                  a solid tumor with at least one identifiable lesion &gt; 1.5 cm as diagnosed by&#xD;
                  conventional imaging.&#xD;
&#xD;
               3. Patient must have adequate kidney function defined as serum creatinine of &lt; 1.5 X&#xD;
                  ULN.&#xD;
&#xD;
               4. Patient must have adequate liver function defined as transaminases (SGOT and/or&#xD;
                  SGPT) may be up to 2.5 X ULN if alkaline phosphatase is &lt;ULN or alkaline&#xD;
                  phosphatase may be up to 2.5 X ULN if Transaminases are &lt; ULN. If alkaline&#xD;
                  phosphatase is outside of these parameters and is due to bone metastases verified&#xD;
                  by assessment of isoenzymes, then the subject is eligible.&#xD;
&#xD;
               5. Patient must provide written informed consent prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients must be excluded in any of the following conditions are present:&#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 within 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>
  <overall_official>
    <last_name>Nelson M Oyesiku, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 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>recurrent or metastatic cancer</keyword>
  <keyword>head and neck cancer</keyword>
  <keyword>pancreas cancer</keyword>
  <keyword>bladder cancer</keyword>
  <keyword>testicular cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neoplasms, Second Primary</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Testicular Neoplasms</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/NCT01684098
org study id: EC20.8
nct id: NCT01684098
lead sponsor: 
The folate receptor is over-expressed on many types of cancer cells and new folate receptor
      targeted therapies are being developed to target cancer cells that over-express the folate
      receptor. As with other targeted therapies, it is important to develop diagnostic tests that
      will provide accurate information on folate receptor status and aid in selecting patients
      that may benefit from folate-targeted therapy.
This Phase II, limited institution, open-label, single-arm, baseline-controlled study is
      designed to obtain data on the percentage of patients with recurrent or metastatic cancer
      from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver,
      colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased
      uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the
      FolateScan images, and verify product safety in patients with suspected recurrent or
      metastatic disease from any solid tumor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
arm group label: Tc 99m EC20
arm group type: Other
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
last name: Nelson M Oyesiku, MD, PhD
role: Principal Investigator
affiliation: Emory University
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Urinary Bladder Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Neoplasms
mesh term: Neoplasms, Second Primary
mesh term: Pancreatic Neoplasms
mesh term: Testicular Neoplasms
mesh term: Recurrence
mesh term: Technetium Tc 99m-ethylenedicysteine