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/NCT06007859</url>
    </required_header>
    <id_info>
      <org_study_id>YXLL-KY-2023(024)</org_study_id>
      <nct_id>NCT06007859</nct_id>
    </id_info>
    <brief_title>Patients Who Underwent Thyroid Ultrasonography at Our Institution Were Selected for Shear Wave Elastography of Thyroid Nodules, and the Maximum and Mean Values of the Modulus of Elasticity of the Nodules in Transverse and Longitudinal Sections Were Analyzed.</brief_title>
    <acronym>SWE</acronym>
    <official_title>Influence of Section Orientation of Ultrasound Shear Wave Elastography on the Measurement of Thyroid Nodules Stiffness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ma Zhe</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qianfoshan 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>
        The objective of this observational study was to evaluate the effect of transverse and&#xD;
        longitudinal sections on the measurement of thyroid nodule stiffness by shear wave&#xD;
        elastography. The main questions it aims to answer are: (i) to compare the diagnostic&#xD;
        efficacy of different section orientations of shear wave elastography for the diagnosis of&#xD;
        benign and malignant thyroid nodules; (ii) to analyze the correlation between the two&#xD;
        orientations of transverse and longitudinal sections of shear wave elastography; and (iii) to&#xD;
        compare the reliability and consistency of the two orientations of transverse and&#xD;
        longitudinal sections of shear wave elastography for the diagnosis of thyroid nodules.&#xD;
        Participants will undergo routine ultrasound examination of the thyroid gland and shear wave&#xD;
        elastography, and the measured modulus of elasticity of the nodules in both transverse and&#xD;
        longitudinal sections will be recorded.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">November 30, 2022</completion_date>
    <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>elastic modulus values</measure>
      <time_frame>The elastic modulus values of different sections were recorded immediately after the patients underwent routine ultrasound and shear wave elastography and the recorded results were saved.</time_frame>
      <description>the maximum value of elastic modulus (Emax) and the average value of elastic modulus (Emean) of benign and malignant nodules in both longitudinal and transverse sections</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">67</enrollment>
    <condition>Thyroid Nodules</condition>
    <arm_group>
      <arm_group_label>section orientation of ultrasound shear wave elastography</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>section orientation</intervention_name>
      <description>The patient was placed in a decubitus supine head back extension position to fully expose the cervical thyroid examination site. The instrument was adjusted appropriately to achieve optimal imaging quality, the suspicious nodule was located in conventional ultrasound mode, the SWE option in VT mode was selected, and the patient was instructed to hold his/her breath to minimize the effect of respiration, and elastograms of the nodule in transverse and longitudinal sections were obtained.</description>
      <arm_group_label>section orientation of ultrasound shear wave elastography</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with thyroid nodules attending the First Affiliated Hospital of Shandong First&#xD;
          Medical University were selected.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All patients underwent preoperative shear-wave elastography ultrasonography; thyroid&#xD;
          nodules ranged from 3 to 20 mm in size; all nodules underwent puncture biopsy or surgery to&#xD;
          obtain pathologic results.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Unavailability of pathology results for various reasons; poor quality of ultrasound images;&#xD;
          missing data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>68 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>QianfoshanH</name>
        <address>
          <city>Shandong</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 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 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Qianfoshan Hospital</investigator_affiliation>
      <investigator_full_name>Ma Zhe</investigator_full_name>
      <investigator_title>Director of Ultrasound</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thyroid Nodule</mesh_term>
      <mesh_term>Thyroid Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Lack of resources or infrastructure: Sharing IPDs requires resources and infrastructure to ensure data security, manage access requests and provide necessary documentation. Currently these resources are not well developed, so it may be difficult to share IPDs.</ipd_description>
    </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/NCT06007859
  org study id: YXLL-KY-2023(024)
  nct id: NCT06007859
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this observational study was to evaluate the effect of transverse and
        longitudinal sections on the measurement of thyroid nodule stiffness by shear wave
        elastography. The main questions it aims to answer are: (i) to compare the diagnostic
        efficacy of different section orientations of shear wave elastography for the diagnosis of
        benign and malignant thyroid nodules; (ii) to analyze the correlation between the two
        orientations of transverse and longitudinal sections of shear wave elastography; and (iii) to
        compare the reliability and consistency of the two orientations of transverse and
        longitudinal sections of shear wave elastography for the diagnosis of thyroid nodules.
        Participants will undergo routine ultrasound examination of the thyroid gland and shear wave
        elastography, and the measured modulus of elasticity of the nodules in both transverse and
        longitudinal sections will be recorded.
  observational model: Cohort
  time perspective: Retrospective
  measure: elastic modulus values
  time frame: The elastic modulus values of different sections were recorded immediately after the patients underwent routine ultrasound and shear wave elastography and the recorded results were saved.
  description: the maximum value of elastic modulus (Emax) and the average value of elastic modulus (Emean) of benign and malignant nodules in both longitudinal and transverse sections
  arm group label: section orientation of ultrasound shear wave elastography
  intervention type: Other
  intervention name: section orientation
  description: The patient was placed in a decubitus supine head back extension position to fully expose the cervical thyroid examination site. The instrument was adjusted appropriately to achieve optimal imaging quality, the suspicious nodule was located in conventional ultrasound mode, the SWE option in VT mode was selected, and the patient was instructed to hold his/her breath to minimize the effect of respiration, and elastograms of the nodule in transverse and longitudinal sections were obtained.
  arm group label: section orientation of ultrasound shear wave elastography
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 68 Years
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Qianfoshan Hospital
  investigator full name: Ma Zhe
  investigator title: Director of Ultrasound
  mesh term: Thyroid Nodule
  mesh term: Thyroid Diseases
  sharing ipd: No
  ipd description: Lack of resources or infrastructure: Sharing IPDs requires resources and infrastructure to ensure data security, manage access requests and provide necessary documentation. Currently these resources are not well developed, so it may be difficult to share IPDs.