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/NCT05990478</url>
    </required_header>
    <id_info>
      <org_study_id>23-224</org_study_id>
      <nct_id>NCT05990478</nct_id>
    </id_info>
    <brief_title>A Study of Contrast-Enhanced Mammography (CEM) Scans in People With Breast Cancer</brief_title>
    <official_title>Contrast-Enhanced Mammography With Early and Delayed Acquisitions in the Assessment of the Extent of Residual Disease Following Neoadjuvant Treatment in Patients With Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Memorial Sloan Kettering Cancer Center</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>
        The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans&#xD;
        performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to&#xD;
        identify the amount of residual disease in the breast following neoadjuvant treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 3, 2023</start_date>
    <completion_date type="Anticipated">August 3, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 3, 2027</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>Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition</measure>
      <time_frame>Up to 1 year</time_frame>
      <description>compare the sensitivity and specificity of CEM with standard 'early' acquisition to CEM with delayed acquisition, in detecting breast cancer lesions with pathological complete response (pCR) after NAT.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Participants with Breast Cancer</arm_group_label>
      <description>Participants will have a diagnosis of breast cancer</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Contrast-Enhanced Mammography</intervention_name>
      <description>Participants will have pre- and post-treatment CEM of the affected breast</description>
      <arm_group_label>Participants with Breast Cancer</arm_group_label>
      <other_name>CEM</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Breast MRI</intervention_name>
      <description>Pre- and post-NAT breast MRI will be performed for all participants</description>
      <arm_group_label>Participants with Breast Cancer</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Potential research subjects will be identified by a member of the participant's treatment&#xD;
          team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center&#xD;
          (MSKCC).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any women &gt;18 years of age at time of informed consent&#xD;
  &#xD;
            -  Diagnosed with breast cancer and schedule for NAT&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of kidney disease, creatinine level &gt;1.3 or eGFR &lt;45.&#xD;
  &#xD;
            -  Known allergic reaction to gadolinium or iodinated contrast media.&#xD;
  &#xD;
            -  Contraindication to contrast-enhanced breast MRI.&#xD;
  &#xD;
            -  Lesion not included in the field of view of either pre- or post-NAT MRI or CEM&#xD;
  &#xD;
            -  Presence of pacemakers or automated implantable cardioverter defibrilator&#xD;
  &#xD;
            -  Pregnant women&#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>Joao Machado Horvat, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joao Machado Horvat, MD</last_name>
      <phone>646-888-5462</phone>
      <email>machadoj@mskcc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maxine Jochelson, MD</last_name>
      <phone>646-888-4507</phone>
      <email>jochelsm@mskcc.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Memorial Sloan Kettering at Basking Ridge (All protocol activities)</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joao Machado Horvat, MD</last_name>
        <phone>646-888-5462</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Monmouth (All Protocol Activities)</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joao Machado Horvat, MD</last_name>
        <phone>646-888-5462</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Bergen (All protocol activities)</name>
        <address>
          <city>Montvale</city>
          <state>New Jersey</state>
          <zip>07645</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joao Machado Horvat, MD</last_name>
        <phone>646-888-5462</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joao Machado Horvat, MD</last_name>
        <phone>646-888-5462</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Westchester (All Protocol Activities)</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joao Machado Horvat, MD</last_name>
        <phone>646-888-5462</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center (All protocol activites)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joao Machado Horvat, MD</last_name>
        <phone>646-888-5462</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Nassau (All protocol activities)</name>
        <address>
          <city>Rockville Centre</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joao Machado Horvat, MD</last_name>
        <phone>646-888-5462</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mskcc.org</url>
      <description>Memorial Sloan Kettering Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>breast cancer</keyword>
    <keyword>Memorial Sloan Kettering Cancer Center</keyword>
    <keyword>23-224</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</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/NCT05990478
  org study id: 23-224
  nct id: NCT05990478
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans
        performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to
        identify the amount of residual disease in the breast following neoadjuvant treatment.
  observational model: Cohort
  time perspective: Prospective
  measure: Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
  time frame: Up to 1 year
  description: compare the sensitivity and specificity of CEM with standard 'early' acquisition to CEM with delayed acquisition, in detecting breast cancer lesions with pathological complete response (pCR) after NAT.
  arm group label: Participants with Breast Cancer
  description: Participants will have a diagnosis of breast cancer
  intervention type: Diagnostic Test
  intervention name: Contrast-Enhanced Mammography
  description: Participants will have pre- and post-treatment CEM of the affected breast
  arm group label: Participants with Breast Cancer
  other name: CEM
  intervention type: Diagnostic Test
  intervention name: Breast MRI
  description: Pre- and post-NAT breast MRI will be performed for all participants
  arm group label: Participants with Breast Cancer
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Joao Machado Horvat, MD
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Joao Machado Horvat, MD
  phone: 646-888-5462
  email: machadoj@mskcc.org
  last name: Maxine Jochelson, MD
  phone: 646-888-4507
  email: jochelsm@mskcc.org
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.mskcc.org
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: Yes
  ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.