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/NCT05999214</url>
    </required_header>
    <id_info>
      <org_study_id>XJTU1AF2023LSK-381</org_study_id>
      <nct_id>NCT05999214</nct_id>
    </id_info>
    <brief_title>99mTc-H7ND SPECT/CT Imaging in NSCLC</brief_title>
    <official_title>99mTc-H7ND SPECT/CT Imaging in Non-small Cell Lung Cancer Clinical Application Research in Efficacy Evaluation and Efficacy Prediction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital Xi'an Jiaotong University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To study the clinical application of 99mTc-H7ND SPECT/CT imaging in the efficacy evaluation&#xD;
        and prediction of non-small cell lung cancer (NSCLC)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was a prospective, controlled, single-center clinical study.&#xD;
  &#xD;
        To evaluate the value of 99mTc-H7ND imaging in the evaluation of stable disease in patients&#xD;
        with non-small cell lung cancer (NSCLC) assessed by RECIST1.1, and to predict the efficacy of&#xD;
        subsequent treatment (second-line treatment).&#xD;
  &#xD;
        Patients with NSCLC confirmed by cytology or pathology, who were unable to undergo radical&#xD;
        surgery because of recurrence, metastasis, or their own conditions, and who had completed 2-4&#xD;
        cycles of first-line therapy and had RECIST1.1 assessment (SD) were divided into 2 groups:&#xD;
  &#xD;
        Experimental group: 99mTc-H7ND SPECT/CT imaging performed Control group: 99mTc-H7ND SPECT/CT&#xD;
        imaging was not performed&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">August 10, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 10, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>DCR</measure>
      <time_frame>Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment</time_frame>
      <description>Comparison of DCR in groups of NSCLC patients with stable disease assessed by RECIST1.1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PFS</measure>
      <time_frame>Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment</time_frame>
      <description>The PFS of NSCLC patients with stable disease assessed by RECIST1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment</time_frame>
      <description>The OS of NSCLC patients with stable disease assessed by RECIST1.1</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>NSCLC</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>99mTc-H7ND SPECT/CT imaging was performed</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>99mTc-H7ND SPECT/CT imaging was not performed</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>99mTc-H7ND SPECT/CT imaging performed</intervention_name>
      <description>99mTc-H7ND SPECT/CT imaging positive (+) was defined as the presence of at least one measurable lesion and the uptake of the lesion was greater than that of normal liver in the experimental group, and patients were divided into SD+ and SD-. According to the guidelines and routine clinical practice, SD- patients were treated with the original regimen or maintenance treatment, and SD+ patients were divided into continuation of the original regimen or second-line treatment according to the MDT discussion results.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients aged from 18 to 80 years old;&#xD;
  &#xD;
            2. patients with NSCLC confirmed by needle aspiration cytology or surgical pathology, who&#xD;
               cannot undergo radical surgery due to recurrence, metastasis or patient's own&#xD;
               conditions;&#xD;
  &#xD;
            3. Has completed 2-4 cycles of first-line therapy (including chemotherapy, immunotherapy,&#xD;
               chemotherapy combined with immunotherapy, chemotherapy combined with targeted therapy,&#xD;
               etc.), and has SD assessed by RECIST 1.1 during the same period;&#xD;
  &#xD;
            4. Patients had at least one measurable lesion;&#xD;
  &#xD;
            5. No local radiotherapy for primary or metastatic lesions within 28 days;&#xD;
  &#xD;
            6. ECOG score 0-2;&#xD;
  &#xD;
            7. Expected survival time ≥3 months;&#xD;
  &#xD;
            8. Voluntarily participate and sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Women who plan to become pregnant within 6 months, or are pregnant or lactating.&#xD;
  &#xD;
            2. Patients with severe brain or bone metastases;&#xD;
  &#xD;
            3. Severe anemia and severe liver and kidney damage;&#xD;
  &#xD;
            4. Pathological or long-term follow-up results may not be available;&#xD;
  &#xD;
            5. The relevant control imaging data and clinical data were not available;&#xD;
  &#xD;
            6. Severe illness is difficult to cooperate (such as acute cardiovascular and&#xD;
               cerebrovascular events or serious cardiovascular diseases);&#xD;
  &#xD;
            7. Received any surgery or invasive treatment or procedure within 4 weeks before&#xD;
               enrollment;&#xD;
  &#xD;
            8. Cannot tolerate standard second-line therapy or other first-line therapies.&#xD;
  &#xD;
            9. Known allergy to 99mTc-H7ND or any of its components; He had a history of severe&#xD;
               allergies;&#xD;
  &#xD;
           10. Protocol imaging contraindications were present;&#xD;
  &#xD;
           11. The investigator considered it inappropriate to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rui Gao</last_name>
      <role>Study Chair</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rui Gao</last_name>
      <phone>0086-13772488039</phone>
      <email>jacky_mg@xjtufh.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xinru Li</last_name>
      <phone>0086-15991432495</phone>
      <email>lixinru@xjtu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>First Affiliated Hospital of Xi'an Jiaotong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Rui Gao</last_name>
        <phone>0086-13772488039</phone>
        <email>jacky_mg@xjtufh.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Xinru Li</last_name>
        <phone>0086-15991432495</phone>
        <email>lixinru@xjtu.edu.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>99mTc-H7ND</keyword>
    <keyword>SPECT/CT</keyword>
    <keyword>NSCLC</keyword>
    <keyword>diagnostic efficiency</keyword>
    <keyword>therapeutic effect evaluation</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05999214
  org study id: XJTU1AF2023LSK-381
  nct id: NCT05999214
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To study the clinical application of 99mTc-H7ND SPECT/CT imaging in the efficacy evaluation
        and prediction of non-small cell lung cancer (NSCLC)
  This study was a prospective, controlled, single-center clinical study.
  
        To evaluate the value of 99mTc-H7ND imaging in the evaluation of stable disease in patients
        with non-small cell lung cancer (NSCLC) assessed by RECIST1.1, and to predict the efficacy of
        subsequent treatment (second-line treatment).
  
        Patients with NSCLC confirmed by cytology or pathology, who were unable to undergo radical
        surgery because of recurrence, metastasis, or their own conditions, and who had completed 2-4
        cycles of first-line therapy and had RECIST1.1 assessment (SD) were divided into 2 groups:
  
        Experimental group: 99mTc-H7ND SPECT/CT imaging performed Control group: 99mTc-H7ND SPECT/CT
        imaging was not performed
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: DCR
  time frame: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
  description: Comparison of DCR in groups of NSCLC patients with stable disease assessed by RECIST1.1.
  measure: PFS
  time frame: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
  description: The PFS of NSCLC patients with stable disease assessed by RECIST1.1
  measure: OS
  time frame: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
  description: The OS of NSCLC patients with stable disease assessed by RECIST1.1
  arm group label: Experimental group
  arm group type: Experimental
  description: 99mTc-H7ND SPECT/CT imaging was performed
  arm group label: Control group
  arm group type: No Intervention
  description: 99mTc-H7ND SPECT/CT imaging was not performed
  intervention type: Diagnostic Test
  intervention name: 99mTc-H7ND SPECT/CT imaging performed
  description: 99mTc-H7ND SPECT/CT imaging positive (+) was defined as the presence of at least one measurable lesion and the uptake of the lesion was greater than that of normal liver in the experimental group, and patients were divided into SD+ and SD-. According to the guidelines and routine clinical practice, SD- patients were treated with the original regimen or maintenance treatment, and SD+ patients were divided into continuation of the original regimen or second-line treatment according to the MDT discussion results.
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Rui Gao
  role: Study Chair
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Rui Gao
  phone: 0086-13772488039
  email: jacky_mg@xjtufh.edu.cn
  last name: Xinru Li
  phone: 0086-15991432495
  email: lixinru@xjtu.edu.cn
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No