<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/NCT03031522</url>
  </required_header>
  <id_info>
    <org_study_id>14006</org_study_id>
    <nct_id>NCT03031522</nct_id>
  </id_info>
  <brief_title>EGFR Molecular Classification In Vivo</brief_title>
  <official_title>Molecular Imaging to Identify EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harbin Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and&#xD;
      repeatable detecting EGFR-activating mutational status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of investigators were to evaluate the use of 18F-IRS as a novel PET/CT radiotracer&#xD;
      to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients.&#xD;
      the investigators want to evaluated the use of 18F-IRS in lung cancer imaging in adult NSCLC&#xD;
      patients with different EGFR mutational status of primary and metastatic cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>tumor SUVmax value of 18F-IRS PET/CT Imaging</measure>
    <time_frame>at time of imaging</time_frame>
    <description>To quantify the accumulation, a volume of interest using a 3-D sphere, was placed over the primary lung tumor, lymph nodes and distant metastases avoiding necrosis, blood vessels and normal lung tissue as much as possible on a workstation (Advantage Workstation 4.6; GE Healthcare). The maximum standard uptake value (SUVmax) normalized to body weight (kBq/mL) was calculated within the region of interest.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Molecular Imaging</condition>
  <arm_group>
    <arm_group_label>18F-IRS : EGFR+ Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>18F-IRS :post-TKI EGFR+ Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>18F-IRS:post-chemo EGFR+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>18F-IRS:post-chemo EGFR+ Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>18F-IRS:EGFR wild type</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>18F-IRS:post-chemo EGFR wild type</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>18F-IRS:unknown EGFR mutational status</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>18F-IRS</intervention_name>
    <description>According to experiment, 18F-IRS was non-toxic and stable in serum.</description>
    <arm_group_label>18F-IRS : EGFR+ Patients</arm_group_label>
    <arm_group_label>18F-IRS :post-TKI EGFR+ Patients</arm_group_label>
    <arm_group_label>18F-IRS:EGFR wild type</arm_group_label>
    <arm_group_label>18F-IRS:post-chemo EGFR wild type</arm_group_label>
    <arm_group_label>18F-IRS:post-chemo EGFR+</arm_group_label>
    <arm_group_label>18F-IRS:unknown EGFR mutational status</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced NSCLC&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  A life expectancy of at least 12 weeks&#xD;
&#xD;
          -  Presence of a malignant lesion within the chest of at least 0.5 cm diameter as&#xD;
             measured by computed tomography (CT)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Metal implants in the thorax&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baozhong Shen, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The Fourth Hospital of Harbin Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150028</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harbin Medical University</investigator_affiliation>
    <investigator_full_name>Yingying Sun</investigator_full_name>
    <investigator_title>Chief</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03031522
org study id: 14006
nct id: NCT03031522
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and
      repeatable detecting EGFR-activating mutational status.
The goal of investigators were to evaluate the use of 18F-IRS as a novel PET/CT radiotracer
      to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients.
      the investigators want to evaluated the use of 18F-IRS in lung cancer imaging in adult NSCLC
      patients with different EGFR mutational status of primary and metastatic cancers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: tumor SUVmax value of 18F-IRS PET/CT Imaging
time frame: at time of imaging
description: To quantify the accumulation, a volume of interest using a 3-D sphere, was placed over the primary lung tumor, lymph nodes and distant metastases avoiding necrosis, blood vessels and normal lung tissue as much as possible on a workstation (Advantage Workstation 4.6; GE Healthcare). The maximum standard uptake value (SUVmax) normalized to body weight (kBq/mL) was calculated within the region of interest.
arm group label: 18F-IRS : EGFR+ Patients
arm group type: Experimental
description: Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study.
arm group label: 18F-IRS :post-TKI EGFR+ Patients
arm group type: Experimental
description: Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study .
arm group label: 18F-IRS:post-chemo EGFR+
arm group type: Experimental
description: 18F-IRS:post-chemo EGFR+ Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study.
arm group label: 18F-IRS:EGFR wild type
arm group type: Experimental
description: Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.
arm group label: 18F-IRS:post-chemo EGFR wild type
arm group type: Experimental
description: Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study.
arm group label: 18F-IRS:unknown EGFR mutational status
arm group type: Experimental
description: Patients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group
intervention type: Radiation
intervention name: 18F-IRS
description: According to experiment, 18F-IRS was non-toxic and stable in serum.
arm group label: 18F-IRS : EGFR+ Patients
arm group label: 18F-IRS :post-TKI EGFR+ Patients
arm group label: 18F-IRS:EGFR wild type
arm group label: 18F-IRS:post-chemo EGFR wild type
arm group label: 18F-IRS:post-chemo EGFR+
arm group label: 18F-IRS:unknown EGFR mutational status
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Baozhong Shen, M.D.
role: Study Chair
affiliation: The Fourth Hospital of Harbin Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Harbin Medical University
investigator full name: Yingying Sun
investigator title: Chief
sharing ipd: Undecided