<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/NCT04498611</url>
  </required_header>
  <id_info>
    <org_study_id>2004-219-1119</org_study_id>
    <nct_id>NCT04498611</nct_id>
  </id_info>
  <brief_title>Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy</brief_title>
  <official_title>Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy: A Development and Validation Study</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>
      It is considered that whether or not the accompanying invasive cancer classified through MRI&#xD;
      images of breast cancer patients identified as Ductal Carcinoma in situ (DCIS) through&#xD;
      preoperative tissue biopsy is significantly consistent with the postoperative stage.&#xD;
&#xD;
      Therefore, this study intend to evaluate the effectiveness as a diagnostic tool that can help&#xD;
      determine the axillary lymph node surgery by predicting the possibility of post-operative&#xD;
      up-staging using magnetic resonance imagings of breast cancer patients who have been&#xD;
      identified as ductal carcinoma in situ and are scheduled for surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To date, there is no significant research data on the value of the Apparent Diffusion&#xD;
           Coefficient (ADC) that can distinguish between pure Ductal Carcinoma in situ (pure DCIS)&#xD;
           and invasive cancer (DCIS-IC), from June 2019 to 2020 1 Of the 144 patients who obtained&#xD;
           Diffusion Weighted images (b=0,800,1200) with 3.0-T MRI equipment and diagnosed with&#xD;
           ductal carcinoma in situ on the biopsy, among 144 patients who did not undergo&#xD;
           preoperative chemotherapy using a CAD program, the 3-dimensional Apparent Diffusion&#xD;
           Coefficient value of the tumor is measured and compared with whether or not there is&#xD;
           invasive cancer after surgery, and the optimal Apparent Diffusion Coefficient reference&#xD;
           value that can predict the invasive cancer will be retrospectively derived.&#xD;
&#xD;
        2. Scheduled MRI tests will be performed on patients enrolled from July 2020, and will be&#xD;
           performed using the standard protocols (3T, contrast enhancement and diffuse enhancement&#xD;
           images DWI b0,800,1200). Among the MRI images taken, the range of lesions is evaluated&#xD;
           in contrast-enhanced T1-highlighted images, and the Apparent Diffusion Coefficient&#xD;
           values of the lesions are three-dimensionally mapped using a CAD program and histogram&#xD;
           analysis on diffused images. The ADC reference value derived from the retrospective&#xD;
           analysis is used to predict prospectively for invasive cancer in all lesions.&#xD;
&#xD;
        3. Mastectomy is performed according to the existing surgical method. Axillary lymph node&#xD;
           surgery is determined according to the existing decision method (tumor location, size,&#xD;
           range, histological grade, etc.).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">August 15, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparing of Preoperative MRI and Postoperative histopathologic results</measure>
    <time_frame>2 weeks after surgery</time_frame>
    <description>Analysis of the concordance rate (%) of invasive cancers confirmed in the final histopathology after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparing the predicted upstaging rate through the MRI and histopathologic results</measure>
    <time_frame>3 weeks after surgery</time_frame>
    <description>Analysis the proportion of up-staging(%) of invasion cancer in the final histopathology.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Carcinoma, Ductal, Breast</condition>
  <condition>Invasive Breast Cancer</condition>
  <condition>IMAGE</condition>
  <arm_group>
    <arm_group_label>breast DCIS patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breast DCIS patients who diagnosed by tissue biopsy except excisional biopsy before surgery, and who agreed to taking the breast MRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>contrast-enhanced breast MRI</intervention_name>
    <description>Contrast-enhanced MRI will be performed on patients diagnosed with ductal carcinoma in-situ (DCIS) by preoperative biopsy.</description>
    <arm_group_label>breast DCIS patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult over 19 years-old&#xD;
&#xD;
          -  Breast Ductal Carcinoma in-situ patients who diagnosed preoperative tissue biopsy&#xD;
&#xD;
          -  A person who understands this study and agrees with willingness to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ductal Carcinoma in-situ which diagnosed excisional biopsy&#xD;
&#xD;
          -  When there is no lesion that can be discriminated from magnetic resonance imaging&#xD;
&#xD;
          -  Neoadjuvant chemotherapy patients&#xD;
&#xD;
          -  Patients who have complication (hematoma, abscess etc.) after preoperative biopsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyeong-Gon Moon</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Jongno-gu</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Mori N, Ota H, Mugikura S, Takasawa C, Tominaga J, Ishida T, Watanabe M, Takase K, Takahashi S. Detection of invasive components in cases of breast ductal carcinoma in situ on biopsy by using apparent diffusion coefficient MR parameters. Eur Radiol. 2013 Oct;23(10):2705-12. doi: 10.1007/s00330-013-2902-2. Epub 2013 Jun 4.</citation>
    <PMID>23732688</PMID>
  </reference>
  <reference>
    <citation>Baxter GC, Graves MJ, Gilbert FJ, Patterson AJ. A Meta-analysis of the Diagnostic Performance of Diffusion MRI for Breast Lesion Characterization. Radiology. 2019 Jun;291(3):632-641. doi: 10.1148/radiol.2019182510. Epub 2019 Apr 23.</citation>
    <PMID>31012817</PMID>
  </reference>
  <reference>
    <citation>Surov A, Meyer HJ, Wienke A. Can apparent diffusion coefficient (ADC) distinguish breast cancer from benign breast findings? A meta-analysis based on 13 847 lesions. BMC Cancer. 2019 Oct 15;19(1):955. doi: 10.1186/s12885-019-6201-4.</citation>
    <PMID>31615463</PMID>
  </reference>
  <reference>
    <citation>Lamb LR, Lehman CD, Oseni TO, Bahl M. Ductal Carcinoma In Situ (DCIS) at Breast MRI: Predictors of Upgrade to Invasive Carcinoma. Acad Radiol. 2020 Oct;27(10):1394-1399. doi: 10.1016/j.acra.2019.09.025. Epub 2019 Nov 4.</citation>
    <PMID>31699638</PMID>
  </reference>
  <reference>
    <citation>Lee KH, Han JW, Kim EY, Yun JS, Park YL, Park CH. Predictive factors for the presence of invasive components in patients diagnosed with ductal carcinoma in situ based on preoperative biopsy. BMC Cancer. 2019 Dec 10;19(1):1201. doi: 10.1186/s12885-019-6417-3.</citation>
    <PMID>31822268</PMID>
  </reference>
  <reference>
    <citation>Borlinhas F, Conceicao RC, Ferreira HA. Optimal b-values for diffusion kurtosis imaging in invasive ductal carcinoma versus ductal carcinoma in situ breast lesions. Australas Phys Eng Sci Med. 2019 Sep;42(3):871-885. doi: 10.1007/s13246-019-00773-2. Epub 2019 Jul 18.</citation>
    <PMID>31321627</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>February 25, 2022</last_update_submitted>
  <last_update_submitted_qc>February 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hyeong-Gon Moon</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Carcinoma, Ductal</mesh_term>
    <mesh_term>Carcinoma, Intraductal, Noninfiltrating</mesh_term>
    <mesh_term>Carcinoma, Ductal, Breast</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/NCT04498611
org study id: 2004-219-1119
nct id: NCT04498611
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It is considered that whether or not the accompanying invasive cancer classified through MRI
      images of breast cancer patients identified as Ductal Carcinoma in situ (DCIS) through
      preoperative tissue biopsy is significantly consistent with the postoperative stage.

      Therefore, this study intend to evaluate the effectiveness as a diagnostic tool that can help
      determine the axillary lymph node surgery by predicting the possibility of post-operative
      up-staging using magnetic resonance imagings of breast cancer patients who have been
      identified as ductal carcinoma in situ and are scheduled for surgery.
1. To date, there is no significant research data on the value of the Apparent Diffusion
           Coefficient (ADC) that can distinguish between pure Ductal Carcinoma in situ (pure DCIS)
           and invasive cancer (DCIS-IC), from June 2019 to 2020 1 Of the 144 patients who obtained
           Diffusion Weighted images (b=0,800,1200) with 3.0-T MRI equipment and diagnosed with
           ductal carcinoma in situ on the biopsy, among 144 patients who did not undergo
           preoperative chemotherapy using a CAD program, the 3-dimensional Apparent Diffusion
           Coefficient value of the tumor is measured and compared with whether or not there is
           invasive cancer after surgery, and the optimal Apparent Diffusion Coefficient reference
           value that can predict the invasive cancer will be retrospectively derived.

        2. Scheduled MRI tests will be performed on patients enrolled from July 2020, and will be
           performed using the standard protocols (3T, contrast enhancement and diffuse enhancement
           images DWI b0,800,1200). Among the MRI images taken, the range of lesions is evaluated
           in contrast-enhanced T1-highlighted images, and the Apparent Diffusion Coefficient
           values of the lesions are three-dimensionally mapped using a CAD program and histogram
           analysis on diffused images. The ADC reference value derived from the retrospective
           analysis is used to predict prospectively for invasive cancer in all lesions.

        3. Mastectomy is performed according to the existing surgical method. Axillary lymph node
           surgery is determined according to the existing decision method (tumor location, size,
           range, histological grade, etc.).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparing of Preoperative MRI and Postoperative histopathologic results
time frame: 2 weeks after surgery
description: Analysis of the concordance rate (%) of invasive cancers confirmed in the final histopathology after surgery.
measure: Comparing the predicted upstaging rate through the MRI and histopathologic results
time frame: 3 weeks after surgery
description: Analysis the proportion of up-staging(%) of invasion cancer in the final histopathology.
arm group label: breast DCIS patients
arm group type: Experimental
description: Breast DCIS patients who diagnosed by tissue biopsy except excisional biopsy before surgery, and who agreed to taking the breast MRI.
intervention type: Diagnostic Test
intervention name: contrast-enhanced breast MRI
description: Contrast-enhanced MRI will be performed on patients diagnosed with ductal carcinoma in-situ (DCIS) by preoperative biopsy.
arm group label: breast DCIS patients
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hyeong-Gon Moon
role: Study Director
affiliation: Seoul National University of Medicine
facility: 
country: Korea, Republic of
citation: Mori N, Ota H, Mugikura S, Takasawa C, Tominaga J, Ishida T, Watanabe M, Takase K, Takahashi S. Detection of invasive components in cases of breast ductal carcinoma in situ on biopsy by using apparent diffusion coefficient MR parameters. Eur Radiol. 2013 Oct;23(10):2705-12. doi: 10.1007/s00330-013-2902-2. Epub 2013 Jun 4.
PMID: 23732688
citation: Baxter GC, Graves MJ, Gilbert FJ, Patterson AJ. A Meta-analysis of the Diagnostic Performance of Diffusion MRI for Breast Lesion Characterization. Radiology. 2019 Jun;291(3):632-641. doi: 10.1148/radiol.2019182510. Epub 2019 Apr 23.
PMID: 31012817
citation: Surov A, Meyer HJ, Wienke A. Can apparent diffusion coefficient (ADC) distinguish breast cancer from benign breast findings? A meta-analysis based on 13 847 lesions. BMC Cancer. 2019 Oct 15;19(1):955. doi: 10.1186/s12885-019-6201-4.
PMID: 31615463
citation: Lamb LR, Lehman CD, Oseni TO, Bahl M. Ductal Carcinoma In Situ (DCIS) at Breast MRI: Predictors of Upgrade to Invasive Carcinoma. Acad Radiol. 2020 Oct;27(10):1394-1399. doi: 10.1016/j.acra.2019.09.025. Epub 2019 Nov 4.
PMID: 31699638
citation: Lee KH, Han JW, Kim EY, Yun JS, Park YL, Park CH. Predictive factors for the presence of invasive components in patients diagnosed with ductal carcinoma in situ based on preoperative biopsy. BMC Cancer. 2019 Dec 10;19(1):1201. doi: 10.1186/s12885-019-6417-3.
PMID: 31822268
citation: Borlinhas F, Conceicao RC, Ferreira HA. Optimal b-values for diffusion kurtosis imaging in invasive ductal carcinoma versus ductal carcinoma in situ breast lesions. Australas Phys Eng Sci Med. 2019 Sep;42(3):871-885. doi: 10.1007/s13246-019-00773-2. Epub 2019 Jul 18.
PMID: 31321627
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hyeong-Gon Moon
investigator title: associate professor
mesh term: Carcinoma
mesh term: Carcinoma in Situ
mesh term: Carcinoma, Ductal
mesh term: Carcinoma, Intraductal, Noninfiltrating
mesh term: Carcinoma, Ductal, Breast