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/NCT06033573</url>
    </required_header>
    <id_info>
      <org_study_id>0519-01</org_study_id>
      <nct_id>NCT06033573</nct_id>
    </id_info>
    <brief_title>Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Mammography</brief_title>
    <official_title>Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Spectral Mammography: an Exploratory Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wuhan Union Hospital, China</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of the prospective, interventional, self-control, open, single-center clinical&#xD;
        study: is to evaluate the value of the delayed ductal imaging of contrast enhanced Spectral&#xD;
        Mammography acquired in 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography&#xD;
        for the clinical diagnosis of patients with suspected pathologic nipple discharge.&#xD;
  &#xD;
        The main questions aim to answer are:&#xD;
  &#xD;
          1. Percentage of changes from baseline in imaging diagnosis caused by the results of&#xD;
             delayed imaging.&#xD;
  &#xD;
          2. The rate of reported examination-related adverse events occurred within 7 days of the&#xD;
             delayed ductal imaging.&#xD;
  &#xD;
          3. The average gland dose (AGD) of delayed ductal imaging.&#xD;
  &#xD;
        After enrollment, subjects underwent CESM again within 4-6 hours post completing previous&#xD;
        routine ductography to obtain a late-phase ductal image, which contains a low-energy image&#xD;
        and a subtracted image obtained from the post processing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        As an exploratory study, the study plans to conduct another imaging using contrast-enhanced&#xD;
        spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced&#xD;
        ductography, so as to explore the optimization of the ductography technique and attempt to&#xD;
        make a systematic description of the mammary duct structure in the Chinese population of&#xD;
        patients with pathological nipple discharge, and thus to assess the clinical value of this&#xD;
        delayed imaging protocol, including the effectiveness of the diagnostic dimension of the&#xD;
        disease and the safety of the radiation dose and the degree of patient tolerance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging</measure>
      <time_frame>4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography</time_frame>
      <description>Changes include any of the following:&#xD;
  Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10)&#xD;
  Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found&#xD;
  Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diagnostic accuracy of delayed ductal imaging results for the nature of the lesion</measure>
      <time_frame>4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography</time_frame>
      <description>Accuracy = (Number of true positive + Number of true negative) /total number x 100% with using pathological findings as reference standard</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging in patients with dense breasts.</measure>
      <time_frame>4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography</time_frame>
      <description>Changes include any of the following:&#xD;
  Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10)&#xD;
  Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found&#xD;
  Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging in patients with non-palpable breast mass/no abnormal findings on palpation</measure>
      <time_frame>4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography</time_frame>
      <description>Changes include any of the following:&#xD;
  Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10)&#xD;
  Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found&#xD;
  Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Kappa values for the evaluation of diagnostic imaging results of delayed ductal imaging by different radiologists.</measure>
      <time_frame>4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography</time_frame>
      <description>Evaluate the agreement on the diagnostic evaluation of delayed images by assessors using the Kappa test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scores for diagnostic confidence of radiologists before and after obtaining delayed ductal imaging result.</measure>
      <time_frame>4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography</time_frame>
      <description>on a 5-point rating scale (1-5)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>The rate of reported examination-related adverse events occurred within 7 days of delayed ductal imaging.</measure>
      <time_frame>7 days post delayed ductal imaging.</time_frame>
      <description>Any discomfort and associated medical diagnoses post ductal imagine</description>
    </other_outcome>
    <other_outcome>
      <measure>The average gland dose of delayed ductal imaging.</measure>
      <time_frame>During imaging procedure</time_frame>
      <description>Total radiation of low-energy and subtracted images of delayed ductal imaging from the craniocaudal projection (CC) and the mediolateral projection (ML) of either mammary gland</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Nipple Discharge</condition>
    <arm_group>
      <arm_group_label>Contrast-enhanced spectral mammography arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects receiving contrast-enhanced spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>contrast-enhanced spectral mammography</intervention_name>
      <description>After enrollment, subjects should undergo contrast-enhanced spectral mammography again within 4-6 hours post completing previous routine ductography to obtain a late-phase ductal image, which contains a low-energy image and a subtracted image obtained from the post processing</description>
      <arm_group_label>Contrast-enhanced spectral mammography arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Females aged 18-65 years old&#xD;
  &#xD;
            -  Completed routine iopromide 370 mgI/ml enhanced ductography for initial clinical&#xD;
               diagnosis of suspected pathological nipple discharge, under the recommendation of the&#xD;
               clinician&#xD;
  &#xD;
            -  Signed informed consent form for this study (signature and date)&#xD;
  &#xD;
            -  Committed to complying with study procedures and cooperating with the conducting of&#xD;
               the full study process&#xD;
  &#xD;
            -  For women of childbearing age, should have taken contraceptive measures for at least&#xD;
               one month prior to screening and must have a negative serum or urine pregnancy test,&#xD;
               meanwhile committed to take contraceptive measures during the entire study and&#xD;
               continue until a specified time after the end of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating women&#xD;
  &#xD;
            -  Experienced any episode of adverse events or discomfort after ductography with&#xD;
               iopromide 370 mgI/ml&#xD;
  &#xD;
            -  Had any history of breast surgery, such as having undergone any invasive examination&#xD;
               or surgical treatment due to the studied disease, including but not limited to breast&#xD;
               duct micro-endoscopy, puncture biopsy, surgery, etc&#xD;
  &#xD;
            -  The ductal discharge symptom is more likely caused by other diagnosed/highly suspected&#xD;
               diseases rather than a breast lesion, such as pituitary adenomas&#xD;
  &#xD;
            -  Other conditions are inappropriate for participation in this study judged by the&#xD;
               investigator, such as the patient had difficulty to cooperate with ductography&#xD;
               procedure, for example, loss of consciousness, communication impairment or nipple&#xD;
               anomalies, and overly slender ducts&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fan Yang, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Union Hospital of Tongji Medical College of Huazhong University of Science and Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fan Yang, Dr.</last_name>
      <phone>008685726114</phone>
      <email>fyang@vip.163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Juan Tao, Dr.</last_name>
      <phone>008685726114</phone>
      <email>taojuan@hust.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Union Hospital of Tongji Medical College of Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Juan Tao, Dr.</last_name>
        <phone>008685726114</phone>
        <email>taojuan@hust.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>pathologic nipple discharge</keyword>
    <keyword>contrast-enhanced spectral mammography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Galactorrhea</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>China Policy does not allow investigator to disclose individual participant data.</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/NCT06033573
  org study id: 0519-01
  nct id: NCT06033573
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the prospective, interventional, self-control, open, single-center clinical
        study: is to evaluate the value of the delayed ductal imaging of contrast enhanced Spectral
        Mammography acquired in 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
        for the clinical diagnosis of patients with suspected pathologic nipple discharge.
  
        The main questions aim to answer are:
  
          1. Percentage of changes from baseline in imaging diagnosis caused by the results of
             delayed imaging.
  
          2. The rate of reported examination-related adverse events occurred within 7 days of the
             delayed ductal imaging.
  
          3. The average gland dose (AGD) of delayed ductal imaging.
  
        After enrollment, subjects underwent CESM again within 4-6 hours post completing previous
        routine ductography to obtain a late-phase ductal image, which contains a low-energy image
        and a subtracted image obtained from the post processing.
  As an exploratory study, the study plans to conduct another imaging using contrast-enhanced
        spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced
        ductography, so as to explore the optimization of the ductography technique and attempt to
        make a systematic description of the mammary duct structure in the Chinese population of
        patients with pathological nipple discharge, and thus to assess the clinical value of this
        delayed imaging protocol, including the effectiveness of the diagnostic dimension of the
        disease and the safety of the radiation dose and the degree of patient tolerance.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging
  time frame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
  description: Changes include any of the following:
  Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10)
  Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found
  Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard
  measure: Diagnostic accuracy of delayed ductal imaging results for the nature of the lesion
  time frame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
  description: Accuracy = (Number of true positive + Number of true negative) /total number x 100% with using pathological findings as reference standard
  measure: Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging in patients with dense breasts.
  time frame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
  description: Changes include any of the following:
  Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10)
  Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found
  Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard
  measure: Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging in patients with non-palpable breast mass/no abnormal findings on palpation
  time frame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
  description: Changes include any of the following:
  Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10)
  Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found
  Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard
  measure: Kappa values for the evaluation of diagnostic imaging results of delayed ductal imaging by different radiologists.
  time frame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
  description: Evaluate the agreement on the diagnostic evaluation of delayed images by assessors using the Kappa test.
  measure: Scores for diagnostic confidence of radiologists before and after obtaining delayed ductal imaging result.
  time frame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
  description: on a 5-point rating scale (1-5)
  measure: The rate of reported examination-related adverse events occurred within 7 days of delayed ductal imaging.
  time frame: 7 days post delayed ductal imaging.
  description: Any discomfort and associated medical diagnoses post ductal imagine
  measure: The average gland dose of delayed ductal imaging.
  time frame: During imaging procedure
  description: Total radiation of low-energy and subtracted images of delayed ductal imaging from the craniocaudal projection (CC) and the mediolateral projection (ML) of either mammary gland
  arm group label: Contrast-enhanced spectral mammography arm
  arm group type: Experimental
  description: Subjects receiving contrast-enhanced spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
  intervention type: Diagnostic Test
  intervention name: contrast-enhanced spectral mammography
  description: After enrollment, subjects should undergo contrast-enhanced spectral mammography again within 4-6 hours post completing previous routine ductography to obtain a late-phase ductal image, which contains a low-energy image and a subtracted image obtained from the post processing
  arm group label: Contrast-enhanced spectral mammography arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Fan Yang, Dr.
  role: Principal Investigator
  affiliation: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
  last name: Fan Yang, Dr.
  phone: 008685726114
  email: fyang@vip.163.com
  last name: Juan Tao, Dr.
  phone: 008685726114
  email: taojuan@hust.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Galactorrhea
  sharing ipd: No
  ipd description: China Policy does not allow investigator to disclose individual participant data.