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/NCT05964595</url>
    </required_header>
    <id_info>
      <org_study_id>SYSKY-2023-498-01</org_study_id>
      <nct_id>NCT05964595</nct_id>
    </id_info>
    <brief_title>Temporal Diffusion Spectroscopy MRI in Predicting the CPS of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy</brief_title>
    <official_title>Temporal Diffusion Spectroscopy MRI in Predicting the Comprehensive Positive Score of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy in Head and Neck Squamous Cell Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 goal of this observational study is to explore the application of temporal diffusion&#xD;
        spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC).&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the&#xD;
             comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC?&#xD;
  &#xD;
          -  If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the&#xD;
             efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI,&#xD;
             including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo&#xD;
             (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant&#xD;
             therapy.&#xD;
  &#xD;
        There is not a comparison group in our study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Comprehensive positive score</measure>
      <time_frame>1 week before neoadjuvant therapy</time_frame>
      <description>Comprehensive positive score for PD-L1 expression</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pathological response</measure>
      <time_frame>1 month after the last neoadjuvant therapy</time_frame>
      <description>Postoperative pathological tumor residual status</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from maximum transverse tumor diameter after neoadjuvant therapy</measure>
      <time_frame>1 week before the first neoadjuvant therapy and 1 month after the last neoadjuvant therapy</time_frame>
      <description>Maximum transverse tumor diameter before and after neoadjuvant therapy</description>
    </primary_outcome>
    <enrollment type="Anticipated">136</enrollment>
    <condition>Head and Neck Squamous Cell Carcinoma</condition>
    <condition>Magnetic Resonance Imaging</condition>
    <condition>Neoadjuvant Therapy</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The patients first diagnosed with HNSCC by pathological biopsy and proposed to receive&#xD;
          preoperative neoadjuvant therapy at Sun Yat-sen Memorial Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients first diagnosed with head and neck squamous cell carcinoma (HNSCC) by&#xD;
               pathological biopsy&#xD;
  &#xD;
            -  Patients proposed to receive 2-3 courses of neoadjuvant chemotherapy and immunotherapy&#xD;
  &#xD;
            -  Patients without contraindications for MRI, such as nonremovable ferromagnetic metal&#xD;
               foreign body, claustrophobia, renal insufficiency, and previous history of gadolinium&#xD;
               contrast allergy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Less than 10mm in the maximum diameter of the baseline primary tumor&#xD;
  &#xD;
            -  Poor MRI image quality with obvious metal or motion artifacts&#xD;
  &#xD;
            -  The failure to complete the course of neoadjuvant therapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xiaohui Duan, Prof.</last_name>
      <phone>13512762365</phone>
      <email>duanxh5@mail.sysu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lingjie Yang</last_name>
      <phone>15989036151</phone>
      <email>yanglj53@mail2.sysu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sun Yat-sen Memorial Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaohui Duan, Prof.</last_name>
        <phone>13512762365</phone>
        <email>duanxh5@mail.sysu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Head and neck squamous cell Carcinoma</keyword>
    <keyword>Temporal diffusion spectroscopy imaging</keyword>
    <keyword>Programmed death-ligand 1</keyword>
    <keyword>Neoadjuvant therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    </condition_browse>
    <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/NCT05964595
  org study id: SYSKY-2023-498-01
  nct id: NCT05964595
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to explore the application of temporal diffusion
        spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC).
  
        The main questions it aims to answer are:
  
          -  If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the
             comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC?
  
          -  If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the
             efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI,
             including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo
             (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant
             therapy.
  
        There is not a comparison group in our study.
  observational model: Cohort
  time perspective: Prospective
  measure: Comprehensive positive score
  time frame: 1 week before neoadjuvant therapy
  description: Comprehensive positive score for PD-L1 expression
  measure: Pathological response
  time frame: 1 month after the last neoadjuvant therapy
  description: Postoperative pathological tumor residual status
  measure: Change from maximum transverse tumor diameter after neoadjuvant therapy
  time frame: 1 week before the first neoadjuvant therapy and 1 month after the last neoadjuvant therapy
  description: Maximum transverse tumor diameter before and after neoadjuvant therapy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Xiaohui Duan, Prof.
  phone: 13512762365
  email: duanxh5@mail.sysu.edu.cn
  last name: Lingjie Yang
  phone: 15989036151
  email: yanglj53@mail2.sysu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Squamous Cell Carcinoma of Head and Neck
  sharing ipd: No