<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/NCT01717807</url>
  </required_header>
  <id_info>
    <org_study_id>0365-12-HMO</org_study_id>
    <nct_id>NCT01717807</nct_id>
  </id_info>
  <brief_title>C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).</brief_title>
  <acronym>EGFR; PET/CT</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <brief_summary>
    <textblock>
      The EGFR is one of the most frequently overexpressed proteins in various cancers including&#xD;
      lung cancer, and is related to tumor progression and resistance to most treatments.&#xD;
&#xD;
      New treatment strategies targeting EGFR have been developed: &quot;although much work remains to&#xD;
      be done, erlotinib has already established itself as part of the therapeutic armamentarium&#xD;
      against cancer&quot;(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ.&#xD;
      Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)&#xD;
&#xD;
      Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid&#xD;
      in the selection of patients for individualized therapy with EGFR kinase inhibitors.&#xD;
&#xD;
      Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant&#xD;
      tumor burden before the initiation of therapy with EGFR inhibitors.&#xD;
&#xD;
      The purposes of the study are:&#xD;
&#xD;
        1. To adjust an optimal treatment for patients with tumors that have high expression of&#xD;
           EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during&#xD;
           pretreatment work-up; as well as to follow up after treatment response.&#xD;
&#xD;
        2. To recognize patients with advanced pancreatic cancer responding to treatment with&#xD;
           erlotinib and to distinguish them from non-responders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <primary_completion_date type="Anticipated">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>size of tumor and metastasis (mm)</measure>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>lung cancer; advanced pancreatic cancer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>C11-Erlotinib PET/CT</intervention_name>
    <arm_group_label>lung cancer; advanced pancreatic cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        oncological patients with NSC type of lung cancer and with advanced pacreatic cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with NSC type of lung cancer with high expression of EGFR who are candidates&#xD;
             for erlotinib as second / third line of treatment;&#xD;
&#xD;
          -  patients with advanced pancreatic tumor who are candidates for complex gemcitabine and&#xD;
             erlotinib treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of histological diagnosis;&#xD;
&#xD;
          -  not a candidate for erlotinib;&#xD;
&#xD;
          -  pregnancy.&#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_contact>
    <last_name>Marina Orevi, MD</last_name>
    <email>marinaor@hadassah.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eyal Mishani, Phd</last_name>
    <email>eyalmi@ekmd.huji.ac.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hadassah Hebrew University Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Marina Orevi, MD</last_name>
      <email>marinaor@hadassah.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 28, 2012</last_update_submitted>
  <last_update_submitted_qc>October 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epithelial growth factor receptors</keyword>
  <keyword>lung cancer</keyword>
  <keyword>advanced tumor of pancrease</keyword>
  <keyword>erlotinib</keyword>
  <keyword>C11-Erlotinib PET/CT</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erlotinib Hydrochloride</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/NCT01717807
org study id: 0365-12-HMO
nct id: NCT01717807
lead sponsor: 
The EGFR is one of the most frequently overexpressed proteins in various cancers including
      lung cancer, and is related to tumor progression and resistance to most treatments.

      New treatment strategies targeting EGFR have been developed: "although much work remains to
      be done, erlotinib has already established itself as part of the therapeutic armamentarium
      against cancer"(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ.
      Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)

      Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid
      in the selection of patients for individualized therapy with EGFR kinase inhibitors.

      Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant
      tumor burden before the initiation of therapy with EGFR inhibitors.

      The purposes of the study are:

        1. To adjust an optimal treatment for patients with tumors that have high expression of
           EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during
           pretreatment work-up; as well as to follow up after treatment response.

        2. To recognize patients with advanced pancreatic cancer responding to treatment with
           erlotinib and to distinguish them from non-responders.
observational model: Cohort
time perspective: Prospective
measure: Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment
measure: size of tumor and metastasis (mm)
arm group label: lung cancer; advanced pancreatic cancer
intervention type: Other
intervention name: C11-Erlotinib PET/CT
arm group label: lung cancer; advanced pancreatic cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marina Orevi, MD
email: marinaor@hadassah.org.il
last name: Eyal Mishani, Phd
email: eyalmi@ekmd.huji.ac.il
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Erlotinib Hydrochloride