<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/NCT04422457</url>
  </required_header>
  <id_info>
    <org_study_id>2020KT62</org_study_id>
    <nct_id>NCT04422457</nct_id>
  </id_info>
  <brief_title>Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients</brief_title>
  <official_title>Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</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>
      Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system&#xD;
      (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the&#xD;
      key target for COVID-19 infection.&#xD;
&#xD;
      DX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity&#xD;
      reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET&#xD;
      Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection&#xD;
      ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression&#xD;
      under therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2020</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SUV</measure>
    <time_frame>2 years</time_frame>
    <description>The uptake of uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Imaging cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-DX600 PET/CT scans</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>68Ga-DX600 PET/CT</intervention_name>
    <description>DX600, labeled with 68Ga will be used as a molecular imaging tracer for PET/CT scanning</description>
    <arm_group_label>Imaging cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-75 years old; both sex;&#xD;
&#xD;
          -  ECoG 0 or 1;&#xD;
&#xD;
          -  Patients that would undergo biopsy or surgical operation with high ACE2 expression&#xD;
             tumors such as colorectal cancer, renal cancer, pancreatic cancer, gastric cancer,&#xD;
             liver cancer, lung cancer, brain cancer or suspected tumor.&#xD;
&#xD;
          -  use 18F-FDG PET/CT as baseline evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant hepatic or renal dysfunction;&#xD;
&#xD;
          -  Is Pregnant or ready to pregnant;&#xD;
&#xD;
          -  Cannot lie on their back for half an hour;&#xD;
&#xD;
          -  Suffering from claustrophobia or other mental diseases;&#xD;
&#xD;
          -  Refusal to join the clinical study;&#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>
  <location>
    <facility>
      <name>Ethics Committee of Peking University Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Hua Zhu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04422457
org study id: 2020KT62
nct id: NCT04422457
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system
      (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the
      key target for COVID-19 infection.

      DX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity
      reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET
      Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection
      ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression
      under therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: SUV
time frame: 2 years
description: The uptake of uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）
arm group label: Imaging cohort
arm group type: Experimental
description: All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-DX600 PET/CT scans
intervention type: Other
intervention name: 68Ga-DX600 PET/CT
description: DX600, labeled with 68Ga will be used as a molecular imaging tracer for PET/CT scanning
arm group label: Imaging cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Hua Zhu
investigator title: Associate Professor
sharing ipd: No