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/NCT06025461</url>
    </required_header>
    <id_info>
      <org_study_id>YXLL-KY-2023(012)</org_study_id>
      <nct_id>NCT06025461</nct_id>
    </id_info>
    <brief_title>Multimodal Ultrasound Diagnosis Characteristics of Bi-rads Class 4 Breast Lesions</brief_title>
    <official_title>Correlation Between Multi-modal Ultrasound Features and Pathologic Classification of BI-RADS Category 4 Breast Lesions</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>
        Objective: To explore the potential association between the multimodal ultrasound&#xD;
        characteristics and pathological classification of BI-RADS category 4 breast lesions, so as&#xD;
        to clarify the diagnostic characteristics of multimodal ultrasound in different pathological&#xD;
        types BI-RADS category 4 breast lesions.&#xD;
  &#xD;
        Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong&#xD;
        First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their&#xD;
        general clinical features, information on preoperative ultrasound diagnosis, and&#xD;
        postoperative pathologic data were reviewed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 15, 2021</start_date>
    <completion_date type="Actual">March 30, 2023</completion_date>
    <primary_completion_date type="Actual">March 30, 2023</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>elasticity imaging/B-mode ratio</measure>
      <time_frame>Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography</time_frame>
      <description>The ratio of lesion length on strain elastography images to lesion length on grayscale images</description>
    </primary_outcome>
    <primary_outcome>
      <measure>shear wave velocity</measure>
      <time_frame>Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography</time_frame>
      <description>Shear wave velocity values at the hardest point of the lesion and surrounding tissues</description>
    </primary_outcome>
    <primary_outcome>
      <measure>strain ratio</measure>
      <time_frame>Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography</time_frame>
      <description>The ratio of average strain between surrounding tissues at the same depth and the lesion</description>
    </primary_outcome>
    <number_of_groups>5</number_of_groups>
    <enrollment type="Actual">85</enrollment>
    <condition>Breast Disease</condition>
    <arm_group>
      <arm_group_label>fibroadenoma group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>breast hyperplasia group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>other types of benign nodules group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>non-specific invasive carcinoma group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>other types of breast cancer group</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>no intervention</intervention_name>
      <description>no intervention</description>
      <arm_group_label>breast hyperplasia group</arm_group_label>
      <arm_group_label>fibroadenoma group</arm_group_label>
      <arm_group_label>non-specific invasive carcinoma group</arm_group_label>
      <arm_group_label>other types of benign nodules group</arm_group_label>
      <arm_group_label>other types of breast cancer group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who visited in The First Affiliated Hospital of Shandong First Medical University&#xD;
          ＆ Shandong Provincial Qianfoshan Hospital were collected.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Perform ultrasound examination at our hospital before surgery or puncture biopsy;&#xD;
               Complete histopathological data; Two ultrasound physicians with more than 5 years of&#xD;
               experience in breast ultrasound diagnosis were diagnosed as BI-RADS Class 4 based on&#xD;
               preoperative ultrasound images.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Poor image quality; Incomplete clinical data.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>76 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </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 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Breast 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/NCT06025461
  org study id: YXLL-KY-2023(012)
  nct id: NCT06025461
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Objective: To explore the potential association between the multimodal ultrasound
        characteristics and pathological classification of BI-RADS category 4 breast lesions, so as
        to clarify the diagnostic characteristics of multimodal ultrasound in different pathological
        types BI-RADS category 4 breast lesions.
  
        Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong
        First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their
        general clinical features, information on preoperative ultrasound diagnosis, and
        postoperative pathologic data were reviewed.
  observational model: Cohort
  time perspective: Retrospective
  measure: elasticity imaging/B-mode ratio
  time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
  description: The ratio of lesion length on strain elastography images to lesion length on grayscale images
  measure: shear wave velocity
  time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
  description: Shear wave velocity values at the hardest point of the lesion and surrounding tissues
  measure: strain ratio
  time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
  description: The ratio of average strain between surrounding tissues at the same depth and the lesion
  arm group label: fibroadenoma group
  arm group label: breast hyperplasia group
  arm group label: other types of benign nodules group
  arm group label: non-specific invasive carcinoma group
  arm group label: other types of breast cancer group
  intervention type: Other
  intervention name: no intervention
  description: no intervention
  arm group label: breast hyperplasia group
  arm group label: fibroadenoma group
  arm group label: non-specific invasive carcinoma group
  arm group label: other types of benign nodules group
  arm group label: other types of breast cancer group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 30 Years
  maximum age: 76 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Qianfoshan Hospital
  investigator full name: Ma Zhe
  investigator title: Director of Ultrasound
  mesh term: Breast Diseases
  sharing ipd: No