<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/NCT02226081</url>
  </required_header>
  <id_info>
    <org_study_id>BE3</org_study_id>
    <secondary_id>ChiCTR-DDT-14004785</secondary_id>
    <nct_id>NCT02226081</nct_id>
  </id_info>
  <brief_title>ShearWave™ Elastography of Breast Lesions in Chinese Patients</brief_title>
  <acronym>BE3</acronym>
  <official_title>Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SuperSonic Imagine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SuperSonic Imagine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can&#xD;
      improve the characterization (classification) of breast lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chinese women are known to have denser breasts than women in Western countries. Mammography&#xD;
      cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected&#xD;
      by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should&#xD;
      improve the diagnosis of a lesion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in specificity of breast ultrasound imaging when considering stiffness measurements</measure>
    <time_frame>Within 18 months of the study start date</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements</measure>
    <time_frame>Within 18 months of the study start date</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements</measure>
    <time_frame>within 18 months of the study start date</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">2273</enrollment>
  <condition>Breast Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese women (age of majority) who have been referred to a hospital or clinical for a&#xD;
        breast ultrasound evaluation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  known breast lesion that has not been managed or treated&#xD;
&#xD;
          -  referred for a breast ultrasound because of a breast mass found on at least one of the&#xD;
             following examinations:&#xD;
&#xD;
               -  physical palpation&#xD;
&#xD;
               -  mammography&#xD;
&#xD;
               -  ultrasound exam&#xD;
&#xD;
               -  MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are unwilling or unable to provide informed consent&#xD;
&#xD;
          -  Women with breast implants&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6&#xD;
&#xD;
          -  Women with previous ipsilateral breast surgery&#xD;
&#xD;
          -  Women with no visible breast mass on ultrasound examination&#xD;
&#xD;
          -  Women with axillary metastatic lymph nodes only&#xD;
&#xD;
          -  Women with foreign body in the breast&#xD;
&#xD;
          -  Women who are not Chinese nationality&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cai Chang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anhua Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1st Affiliated Hospital of PLAGH (304)</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Liberation Army General Hospital (301)</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Binzhou Medical University</name>
      <address>
        <city>Binzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sichuan Provincial People's Hospital</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Provincial Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial Traditional Chinese Medical Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun-Yat Sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Affiliated Hospital of Harbin University</name>
      <address>
        <city>Harbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hefei 2nd People's Hospital</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Provincial Hospital</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yinzhou People's Hospital</name>
      <address>
        <city>Ningbo</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Affiliated Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>4th Affiliated Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of TISCO</name>
      <address>
        <city>Taiyuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Dayi Hospital</name>
      <address>
        <city>Taiyuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://www.dovepress.com/confirmed-value-of-shear-wave-elastography-for-ultrasound-characteriza-peer-reviewed-article-CMAR</url>
    <description>Full-length article in Cancer Management and Research journal</description>
  </link>
  <results_reference>
    <citation>Lin X, Chang C, Wu C, Chen Q, Peng Y, Luo B, Tang L, Li J, Zheng J, Zhou R, Cui G, Li A, Wang X, Qian L, Zhang J, Wen C, Gay J, Zhang H, Li A, Chen Y. Confirmed value of shear wave elastography for ultrasound characterization of breast masses using a conservative approach in Chinese women: a large-size prospective multicenter trial. Cancer Manag Res. 2018 Oct 11;10:4447-4458. doi: 10.2147/CMAR.S174690. eCollection 2018.</citation>
    <PMID>30349377</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast lesion</keyword>
  <keyword>ultrasound</keyword>
  <keyword>BI-RADS</keyword>
  <keyword>women</keyword>
  <keyword>malignancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02226081
org study id: BE3
secondary id: ChiCTR-DDT-14004785
nct id: NCT02226081
lead sponsor: 
has dmc: No
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can
      improve the characterization (classification) of breast lesions.
Chinese women are known to have denser breasts than women in Western countries. Mammography
      cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected
      by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should
      improve the diagnosis of a lesion.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Increase in specificity of breast ultrasound imaging when considering stiffness measurements
time frame: Within 18 months of the study start date
measure: Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements
time frame: Within 18 months of the study start date
measure: Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements
time frame: within 18 months of the study start date
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cai Chang
role: Principal Investigator
affiliation: Fudan University
last name: Anhua Li
role: Principal Investigator
affiliation: Sun Yat-sen University
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country: China
url: https://www.dovepress.com/confirmed-value-of-shear-wave-elastography-for-ultrasound-characteriza-peer-reviewed-article-CMAR
description: Full-length article in Cancer Management and Research journal
citation: Lin X, Chang C, Wu C, Chen Q, Peng Y, Luo B, Tang L, Li J, Zheng J, Zhou R, Cui G, Li A, Wang X, Qian L, Zhang J, Wen C, Gay J, Zhang H, Li A, Chen Y. Confirmed value of shear wave elastography for ultrasound characterization of breast masses using a conservative approach in Chinese women: a large-size prospective multicenter trial. Cancer Manag Res. 2018 Oct 11;10:4447-4458. doi: 10.2147/CMAR.S174690. eCollection 2018.
PMID: 30349377
responsible party type: Sponsor
mesh term: Breast Neoplasms