<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/NCT03835897</url>
  </required_header>
  <id_info>
    <org_study_id>Breast Screening with DWI</org_study_id>
    <nct_id>NCT03835897</nct_id>
  </id_info>
  <brief_title>Breast Cancer Screening With Diffusion-weighted MRI in Women at High Risk for Breast Cancer</brief_title>
  <official_title>Breast Cancer Screening With Mammography, Ultrasound, Contrast-enhanced MRI, and Diffusion-weighted MRI in Women at High Risk for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University 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>
      A prospective observational multicenter study to compare the outcome of breast cancer&#xD;
      surveillance using mammography, breast US, contrast-enhanced MRI, and diffusion-weighted MR&#xD;
      imaging (DWI) as a screening tool, in the high-risk women for breast cancer.&#xD;
&#xD;
        -  Primary objective: To compare the sensitivity of mammography, breast US,&#xD;
           contrast-enhanced MRI, and DWI for the detection of breast cancer&#xD;
&#xD;
        -  Secondary objective:&#xD;
&#xD;
             1. To compare the specificity of mammography, breast US, contrast-enhanced MRI, and&#xD;
                DWI for the detection of breast cancer&#xD;
&#xD;
             2. To compare the cancer detection rate of mammography, breast US, contrast-enhanced&#xD;
                MRI, and DWI&#xD;
&#xD;
             3. To compare the characteristics of detected cancers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Mammography, breast US, contrast-enhanced MRI, and DWI will be performed on the same day&#xD;
           or within 1 month at baseline and then after 1 year, and images will be interpreted&#xD;
           independently according to the Breast Imaging Reporting and Data System (BI-RADS) by&#xD;
           experienced radiologists.&#xD;
&#xD;
        -  Each eligible woman, who provides informed consent for this study, will undergo&#xD;
           mammography, breast US, contrast-enhanced MRI, and DWI at a 3T MR scanner.&#xD;
&#xD;
        -  Contrast-enhanced breast MRI will be performed before and after a gadolinium-based&#xD;
           contrast agent injection.&#xD;
&#xD;
        -  Before contrast injection, DWI with b-value of 0, 800 and 1200 s/mm2 will be performed&#xD;
           and will transfer into the server.&#xD;
&#xD;
        -  A total of 890 high-risk women for breast cancer will be enrolled in this study.&#xD;
&#xD;
        -  The BI-RADS 3 or higher is defined as test-positive. The reference standard will be a&#xD;
           biopsy or at least 1 year of follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 3, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>Baseline to up to 1 year</time_frame>
    <description>Number of positive examinations with a tissue diagnosis of cancer within 1 year / All cancers present in the population examined in the same time period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity</measure>
    <time_frame>Baseline to up to 1 year</time_frame>
    <description>Number of negative examinations without tissue diagnosis of cancer within 1 year / All examinations without tissue diagnosis of cancer within the same period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer detection rate (CDR)</measure>
    <time_frame>Baseline to up to 1 year</time_frame>
    <description>Number of detected cancers (invasive and in situ cancer) /1000 examinations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biologic characteristics of breast cancer</measure>
    <time_frame>Baseline to up to 1 year</time_frame>
    <description>histologic type, tumor grade, and molecular subtype of breast cancers</description>
  </secondary_outcome>
  <enrollment type="Anticipated">890</enrollment>
  <condition>Breast Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        High-risk women for breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women aged between 30 years and 75 years at the time of enrollment&#xD;
&#xD;
          2. Breast cancer high-risk women who meet one or more of the following criteria: 1) BRCA&#xD;
             mutation carrier or untested first-degree relative of BRCA mutation carrier 2) Family&#xD;
             history of breast cancer in first- or second-degree relatives and lifetime risk &gt;20%&#xD;
             calculated by the Tyrer-Cuzick model 3) Family history of breast cancer in first- or&#xD;
             second-degree relatives and personal history of breast cancer 4) Lobular carcinoma in&#xD;
             situ, atypical ductal hyperplasia, or atypical lobular hyperplasia on previous biopsy&#xD;
             or surgery and lifetime risk &gt;20% calculated by the Tyrer-Cuzick model 5) Thoracic&#xD;
             radiation therapy between the ages of 10 and 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women with symptoms or signs of breast cancer or recurrence&#xD;
&#xD;
          2. Women with bilateral mastectomy&#xD;
&#xD;
          3. Pregnant or lactating women&#xD;
&#xD;
          4. Women who undergo chemotherapy due to malignancy in other organs&#xD;
&#xD;
          5. In cases of contraindications to MRI using contrast media (claustrophobia, renal&#xD;
             insufficiency GFR&lt;30mL/min/1.73m2, metallic foreign body such as pacemaker or clips,&#xD;
             history of severe side effects due to MR contrast agent, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Woo Kyung Moon, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Woo Kyung Moon, MD PhD</last_name>
    <phone>+82220722584</phone>
    <email>moonwk@snu.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hee Jung Shin, MD PhD</last_name>
    <email>docshin@amc.seoul.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Woo Kyung Moon, MD, PhD</last_name>
      <email>moonwk1963@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Woo Kyung Moon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03835897
org study id: Breast Screening with DWI
nct id: NCT03835897
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A prospective observational multicenter study to compare the outcome of breast cancer
      surveillance using mammography, breast US, contrast-enhanced MRI, and diffusion-weighted MR
      imaging (DWI) as a screening tool, in the high-risk women for breast cancer.

        -  Primary objective: To compare the sensitivity of mammography, breast US,
           contrast-enhanced MRI, and DWI for the detection of breast cancer

        -  Secondary objective:

             1. To compare the specificity of mammography, breast US, contrast-enhanced MRI, and
                DWI for the detection of breast cancer

             2. To compare the cancer detection rate of mammography, breast US, contrast-enhanced
                MRI, and DWI

             3. To compare the characteristics of detected cancers
-  Mammography, breast US, contrast-enhanced MRI, and DWI will be performed on the same day
           or within 1 month at baseline and then after 1 year, and images will be interpreted
           independently according to the Breast Imaging Reporting and Data System (BI-RADS) by
           experienced radiologists.

        -  Each eligible woman, who provides informed consent for this study, will undergo
           mammography, breast US, contrast-enhanced MRI, and DWI at a 3T MR scanner.

        -  Contrast-enhanced breast MRI will be performed before and after a gadolinium-based
           contrast agent injection.

        -  Before contrast injection, DWI with b-value of 0, 800 and 1200 s/mm2 will be performed
           and will transfer into the server.

        -  A total of 890 high-risk women for breast cancer will be enrolled in this study.

        -  The BI-RADS 3 or higher is defined as test-positive. The reference standard will be a
           biopsy or at least 1 year of follow-up.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity
time frame: Baseline to up to 1 year
description: Number of positive examinations with a tissue diagnosis of cancer within 1 year / All cancers present in the population examined in the same time period
measure: Specificity
time frame: Baseline to up to 1 year
description: Number of negative examinations without tissue diagnosis of cancer within 1 year / All examinations without tissue diagnosis of cancer within the same period
measure: Cancer detection rate (CDR)
time frame: Baseline to up to 1 year
description: Number of detected cancers (invasive and in situ cancer) /1000 examinations
measure: Biologic characteristics of breast cancer
time frame: Baseline to up to 1 year
description: histologic type, tumor grade, and molecular subtype of breast cancers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Woo Kyung Moon, MD PhD
role: Principal Investigator
affiliation: Professor
last name: Woo Kyung Moon, MD PhD
phone: +82220722584
email: moonwk@snu.ac.kr
last name: Hee Jung Shin, MD PhD
email: docshin@amc.seoul.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Woo Kyung Moon
investigator title: Professor
mesh term: Breast Neoplasms