<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/NCT01689636</url>
  </required_header>
  <id_info>
    <org_study_id>EC20.1</org_study_id>
    <nct_id>NCT01689636</nct_id>
  </id_info>
  <brief_title>Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients</brief_title>
  <official_title>CLINICAL STUDY OF A SINGLE-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND BIODISTRIBUTION OF TECHNETIUM Tc 99m EC20 IN NORMAL VOLUNTEERS AND OVARIAN CANCER PATIENTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endocyte</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endocyte</source>
  <brief_summary>
    <textblock>
      Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of&#xD;
      the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four&#xD;
      subjects with known or suspected ovarian cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a single-center, open-label evaluation of a single injection of Tc 99m EC20&#xD;
      containing 0.1 mg EC20 labeled with 15 - 20 mCi of technetium-99m in normal volunteers and&#xD;
      patients with known or suspected ovarian cancer. Two normal volunteers and two patients also&#xD;
      were to receive an injection of 0.25 - 2.0 mg folic acid 1 to 2 minutes prior to the&#xD;
      injection of Tc 99m EC20. Serial blood samples and urine were collected during the 24-hour&#xD;
      period following each injection for pharmacokinetic evaluation. Serial whole body images were&#xD;
      acquired during the 24-hour postdose period for dosimetry evaluations. Safety was monitored&#xD;
      through predose and postdose physical examinations, electrocardiograms (ECGs), vital signs&#xD;
      and clinical laboratory evaluations. Adverse events were monitored from the time of signing&#xD;
      of Informed Consent to 24 hours postdose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2000</start_date>
  <completion_date type="Actual">July 2002</completion_date>
  <phase>Phase 1</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>
  <primary_outcome>
    <measure>Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Single-center, open-label</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study was designed as a single-center, open-label clinical study to evaluate the safety, pharmacokinetics, dosimetry and metabolism of Tc 99m EC20 in normal volunteers and in patients with known or suspected ovarian cancer.&#xD;
Eight subjects were to be enrolled at one center: four normal subjects, four patients with ovarian cancer. Each subject was to receive a single injection of Tc 99m EC20 complex composed of 0.1 mg ligand (EC20) and 15 - 20 mCi of Tc 99m. Two (2) of the 4 normal subjects and 2 of the 4 patients were to receive an injection of 0.25-2.0 mg folic acid 1-2 minutes prior to the injection of Tc 99m EC20.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tc 99m EC20</intervention_name>
    <arm_group_label>Single-center, open-label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects were to be females 18 years of age or older who met the following&#xD;
             criteria:&#xD;
&#xD;
               1. The four normal subjects were to be normal, as established by medical history,&#xD;
                  physical examination, and laboratory data, including CBC, serum chemistry, and&#xD;
                  urinalysis.&#xD;
&#xD;
               2. The two subjects with obvious advanced stage ovarian cancer were to have either&#xD;
                  histopathologically proven stage 3 or 4 disease or clinically obvious disease&#xD;
                  defined by 2 of the following 3 conditions: (1) pelvic mass (2) omental &quot;caking&quot;,&#xD;
                  or (3) ascites.&#xD;
&#xD;
               3. Subjects were to have newly diagnosed, treatment refractory, or recurrent&#xD;
                  disease. Subjects were to be treatment naïve or at least 2 months since last&#xD;
                  non-surgical treatment. Subjects were to have normal kidney and liver function.&#xD;
&#xD;
               4. The two subjects with suspected ovarian cancer were to have a known mass.&#xD;
                  Subjects were to have normal kidney and liver function.&#xD;
&#xD;
               5. Subjects were to provide informed consent prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The following subjects were to be excluded:&#xD;
&#xD;
               1. Subject was pregnant or breast-feeding.&#xD;
&#xD;
               2. Subject was simultaneously participating in another investigative drug or device&#xD;
                  study, or had completed follow-up phase of any previous study within 30 days&#xD;
                  prior to enrollment in this study.&#xD;
&#xD;
               3. Subject had a known history of chronic abuse of drugs or alcohol or had tested&#xD;
                  positive in the pre-study urine drug abuse screen.&#xD;
&#xD;
               4. Subject was currently taking folic acid supplements and could not stop taking the&#xD;
                  supplements for a period of 3 days (2 days prior to the study and one day after&#xD;
                  last imaging procedure).&#xD;
&#xD;
               5. Subject had physical condition that was unsuitable for radionuclide imaging.&#xD;
&#xD;
               6. Subject had been administered another radiopharmaceutical that would interfere&#xD;
                  with the assessment of the biodistribution 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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Washington University Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 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>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 Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</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/NCT01689636
org study id: EC20.1
nct id: NCT01689636
lead sponsor: 
Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of
      the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four
      subjects with known or suspected ovarian cancer.
This was a single-center, open-label evaluation of a single injection of Tc 99m EC20
      containing 0.1 mg EC20 labeled with 15 - 20 mCi of technetium-99m in normal volunteers and
      patients with known or suspected ovarian cancer. Two normal volunteers and two patients also
      were to receive an injection of 0.25 - 2.0 mg folic acid 1 to 2 minutes prior to the
      injection of Tc 99m EC20. Serial blood samples and urine were collected during the 24-hour
      period following each injection for pharmacokinetic evaluation. Serial whole body images were
      acquired during the 24-hour postdose period for dosimetry evaluations. Safety was monitored
      through predose and postdose physical examinations, electrocardiograms (ECGs), vital signs
      and clinical laboratory evaluations. Adverse events were monitored from the time of signing
      of Informed Consent to 24 hours postdose.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose
time frame: 24 hours
arm group label: Single-center, open-label
arm group type: Experimental
description: The study was designed as a single-center, open-label clinical study to evaluate the safety, pharmacokinetics, dosimetry and metabolism of Tc 99m EC20 in normal volunteers and in patients with known or suspected ovarian cancer.
Eight subjects were to be enrolled at one center: four normal subjects, four patients with ovarian cancer. Each subject was to receive a single injection of Tc 99m EC20 complex composed of 0.1 mg ligand (EC20) and 15 - 20 mCi of Tc 99m. Two (2) of the 4 normal subjects and 2 of the 4 patients were to receive an injection of 0.25-2.0 mg folic acid 1-2 minutes prior to the injection of Tc 99m EC20.
intervention type: Drug
intervention name: Tc 99m EC20
arm group label: Single-center, open-label
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Technetium Tc 99m-ethylenedicysteine