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/NCT05998707</url>
    </required_header>
    <id_info>
      <org_study_id>ZDWY.FSK.024</org_study_id>
      <nct_id>NCT05998707</nct_id>
    </id_info>
    <brief_title>The Application of the New Magnetic Resonance UTE Technique in Thoracic Lesions</brief_title>
    <official_title>The Application of the New Magnetic Resonance Technique-UTE in Thoracic Lesions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fifth Affiliated Hospital, Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fifth Affiliated Hospital, Sun Yat-Sen University</source>
    <oversight_info>
      <has_dmc>No</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>
        Quantitative characteristic values of lung lesions were obtained by UTE technique, so as to&#xD;
        make qualitative diagnosis of benign and malignant lesions. And to explore the clinical&#xD;
        feasibility of CT-like technology - high resolution ZTE technology in the diagnosis of&#xD;
        pulmonary diseases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ultrashort echo time (UTE) sequence can obtain data from T2* for lung imaging before T2*&#xD;
        decays in lung parenchyma with extremely short echo time, which makes up for the defect that&#xD;
        conventional MRI cannot clearly display short T2 tissue imaging, and can provide more&#xD;
        supplementary information for lung CT scan. There has been a lot of research progress in the&#xD;
        evaluation of neonatal lung disease, chronic obstructive airway disease and pneumonia. The 3D&#xD;
        UTE sequence developed on this basis has made great progress in improving the resolution,&#xD;
        signal-to-noise ratio and shortening the scanning time of lung MR Images, and has&#xD;
        successfully obtained submillimeter high-resolution images. The purpose of this study was to&#xD;
        explore the value of MRI ultra-short echo technology in the qualitative diagnosis of benign&#xD;
        and malignant lung lesions, and to explore the clinical application of CT-like technology -&#xD;
        high resolution ZTE technology in the lung.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">June 13, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 13, 2024</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>proton density fat fraction (PDFF)</measure>
      <time_frame>baseline (before surgery)</time_frame>
      <description>Determination of proton density fat fraction by magnetic resonance imaging</description>
    </primary_outcome>
    <primary_outcome>
      <measure>T2 relaxation rate</measure>
      <time_frame>baseline (before surgery)</time_frame>
      <description>R2*</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Magnetization Transfer Ratio (MTR)</measure>
      <time_frame>baseline (before surgery)</time_frame>
      <description>Magnetization Transfer Ratio</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Subjective rating</measure>
      <time_frame>baseline (before surgery)</time_frame>
      <description>rating scale</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Lung Diseases</condition>
    <arm_group>
      <arm_group_label>benign group</arm_group_label>
      <description>benign lesions in the lung</description>
    </arm_group>
    <arm_group>
      <arm_group_label>malignant group</arm_group_label>
      <description>malignant tumor in the lung</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          People who meet the inclusion criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years old;&#xD;
  &#xD;
            2. There are lung lesions, and the solid component is ≥6mm;&#xD;
  &#xD;
            3. Chest CT plain scan or /+ enhanced examination within 4 weeks.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. There are metal implants in the corresponding parts of the chest;&#xD;
  &#xD;
            2. MRI contrast agent allergy;&#xD;
  &#xD;
            3. Claustrophobia;&#xD;
  &#xD;
            4. Pregnant women;&#xD;
  &#xD;
            5. High fever;&#xD;
  &#xD;
            6. Respiratory failure;&#xD;
  &#xD;
            7. Lung lesion biopsy within 4 weeks prior to examination.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shaolin Li</last_name>
      <role>Study Director</role>
      <affiliation>Fifth Affiliated Hospital, Sun Yat-Sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaojun Chen</last_name>
      <phone>+8615820587112</phone>
      <email>422175400@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Radiography department</name>
        <address>
          <city>Zhuhai</city>
          <state>Guangdong</state>
          <zip>519000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaojun Chen</last_name>
        <phone>+8615820587112</phone>
        <email>422175400@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 2, 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>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lung mass, UTE, ZTE, nodule, MRI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</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/NCT05998707
  org study id: ZDWY.FSK.024
  nct id: NCT05998707
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Quantitative characteristic values of lung lesions were obtained by UTE technique, so as to
        make qualitative diagnosis of benign and malignant lesions. And to explore the clinical
        feasibility of CT-like technology - high resolution ZTE technology in the diagnosis of
        pulmonary diseases.
  Ultrashort echo time (UTE) sequence can obtain data from T2* for lung imaging before T2*
        decays in lung parenchyma with extremely short echo time, which makes up for the defect that
        conventional MRI cannot clearly display short T2 tissue imaging, and can provide more
        supplementary information for lung CT scan. There has been a lot of research progress in the
        evaluation of neonatal lung disease, chronic obstructive airway disease and pneumonia. The 3D
        UTE sequence developed on this basis has made great progress in improving the resolution,
        signal-to-noise ratio and shortening the scanning time of lung MR Images, and has
        successfully obtained submillimeter high-resolution images. The purpose of this study was to
        explore the value of MRI ultra-short echo technology in the qualitative diagnosis of benign
        and malignant lung lesions, and to explore the clinical application of CT-like technology -
        high resolution ZTE technology in the lung.
  observational model: Cohort
  time perspective: Prospective
  measure: proton density fat fraction (PDFF)
  time frame: baseline (before surgery)
  description: Determination of proton density fat fraction by magnetic resonance imaging
  measure: T2 relaxation rate
  time frame: baseline (before surgery)
  description: R2*
  measure: Magnetization Transfer Ratio (MTR)
  time frame: baseline (before surgery)
  description: Magnetization Transfer Ratio
  measure: Subjective rating
  time frame: baseline (before surgery)
  description: rating scale
  arm group label: benign group
  description: benign lesions in the lung
  arm group label: malignant group
  description: malignant tumor in the lung
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shaolin Li
  role: Study Director
  affiliation: Fifth Affiliated Hospital, Sun Yat-Sen University
  last name: Xiaojun Chen
  phone: +8615820587112
  email: 422175400@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Lung Diseases
  sharing ipd: No