xml: <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/NCT06030817</url>
    </required_header>
    <id_info>
      <org_study_id>K1999</org_study_id>
      <nct_id>NCT06030817</nct_id>
    </id_info>
    <brief_title>99mTc-CNDG Injection in the Diagnosis of Malignant Tumors</brief_title>
    <official_title>A Prospective Study to Explore the Performance and Efficacy of 99mTc-CNDG Injection in Malignant Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
        Currently, 18F-fluorodeoxyglucose (18F-FDG) is the most widely used tumor imaging agent in&#xD;
        clinical practice. However, the production of 18F requires accelerators and is associated&#xD;
        with relatively high diagnostic costs, which to some extent limits its widespread clinical&#xD;
        application. In comparison to Positron Emission Tomography (PET), Single Photon Emission&#xD;
        Computed Tomography (SPECT) devices are more abundant and offer lower diagnostic expenses.&#xD;
        With the utilization of Cadmium Zinc Telluride (CZT) crystals in SPECT and advancements in&#xD;
        image reconstruction techniques, the resolution and sensitivity of SPECT is continually&#xD;
        improving. Therefore, the development of a simplified and cost-effective novel SPECT tumor&#xD;
        imaging agent holds significant practical significance. This study involved the design and&#xD;
        synthesis of a glucose-derived ligand with a linker containing seven methylene units and an&#xD;
        isonitrile group (CN7DG). The CN7DG ligand was labeled with 99mTc to prepare a more&#xD;
        lipophilic 99mTc-CN7DG complex, aiming to investigate a novel SPECT imaging agent for tumor&#xD;
        imaging.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 11, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</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>Uptake value of 99mTc-CNDG in malignant tumors</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The uptake value was measured in the malignant lesions on 99mTc-CNDG SPECT/CT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lesions detected by 99mTc-CNDG SPECT/CT</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The number of target lesions was calculated by 99mTc-CNDG SPECT/CT</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compared with 18F-FDG PET/CT or CECT</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The number of lesions detected by 99mTc-CNDG SPECT/CT was compared with 18F-FDG PET/CT or CECT</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Malignant Tumor</condition>
    <arm_group>
      <arm_group_label>99mTc-CNDG SPECT/CT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Inject 99mTc-CNDG and then perform SPECT/CT scan.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>99mTc-CNDG SPECT/CT</intervention_name>
      <description>Explore the imaging characteristics of 99mTc-CNDG and its diagnostic efficacy in tumor patients.</description>
      <arm_group_label>99mTc-CNDG SPECT/CT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-70 years old&#xD;
  &#xD;
            -  Patients diagnosed with malignant glioma, colorectal cancer, pancreatic cancer, lung&#xD;
               cancer, breast cancer, or other malignant tumors through imaging techniques such as&#xD;
               MRI, CT, and ultrasound, and who are scheduled for surgical resection or biopsy&#xD;
  &#xD;
            -  Solid tumor sizes greater than 2cm&#xD;
  &#xD;
            -  Voluntarily agree to participate and sign an informed consent form&#xD;
  &#xD;
            -  Can provide complete surgical records, pathological results, control data, and&#xD;
               clinical follow-up results&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pre-treatment such as chemotherapy and targeted therapy has been administered&#xD;
  &#xD;
            -  Pregnancy and breastfeeding&#xD;
  &#xD;
            -  Claustrophobia&#xD;
  &#xD;
            -  The condition is severe and difficult to cooperate with&#xD;
  &#xD;
            -  Unable to obtain relevant control imaging data and clinical information&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hongli Jing</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hongli Jing</last_name>
      <phone>+86-18600586399</phone>
      <email>annsmile1976@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hongli Jing</last_name>
        <phone>+86-18600586399</phone>
        <email>annsmile1976@sina.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030817
  org study id: K1999
  nct id: NCT06030817
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Currently, 18F-fluorodeoxyglucose (18F-FDG) is the most widely used tumor imaging agent in
        clinical practice. However, the production of 18F requires accelerators and is associated
        with relatively high diagnostic costs, which to some extent limits its widespread clinical
        application. In comparison to Positron Emission Tomography (PET), Single Photon Emission
        Computed Tomography (SPECT) devices are more abundant and offer lower diagnostic expenses.
        With the utilization of Cadmium Zinc Telluride (CZT) crystals in SPECT and advancements in
        image reconstruction techniques, the resolution and sensitivity of SPECT is continually
        improving. Therefore, the development of a simplified and cost-effective novel SPECT tumor
        imaging agent holds significant practical significance. This study involved the design and
        synthesis of a glucose-derived ligand with a linker containing seven methylene units and an
        isonitrile group (CN7DG). The CN7DG ligand was labeled with 99mTc to prepare a more
        lipophilic 99mTc-CN7DG complex, aiming to investigate a novel SPECT imaging agent for tumor
        imaging.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Uptake value of 99mTc-CNDG in malignant tumors
  time frame: through study completion, an average of 1 year
  description: The uptake value was measured in the malignant lesions on 99mTc-CNDG SPECT/CT.
  measure: Lesions detected by 99mTc-CNDG SPECT/CT
  time frame: through study completion, an average of 1 year
  description: The number of target lesions was calculated by 99mTc-CNDG SPECT/CT
  measure: Compared with 18F-FDG PET/CT or CECT
  time frame: through study completion, an average of 1 year
  description: The number of lesions detected by 99mTc-CNDG SPECT/CT was compared with 18F-FDG PET/CT or CECT
  arm group label: 99mTc-CNDG SPECT/CT
  arm group type: Experimental
  description: Inject 99mTc-CNDG and then perform SPECT/CT scan.
  intervention type: Diagnostic Test
  intervention name: 99mTc-CNDG SPECT/CT
  description: Explore the imaging characteristics of 99mTc-CNDG and its diagnostic efficacy in tumor patients.
  arm group label: 99mTc-CNDG SPECT/CT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Hongli Jing
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: Hongli Jing
  phone: +86-18600586399
  email: annsmile1976@sina.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms