<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/NCT01716247</url>
  </required_header>
  <id_info>
    <org_study_id>12-214</org_study_id>
    <nct_id>NCT01716247</nct_id>
  </id_info>
  <brief_title>Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer</brief_title>
  <official_title>Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for 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>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM)&#xD;
      will be able to detect smaller/earlier breast cancers as well as breast MRI can.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>compare the sensitivity and specificity CESM</measure>
    <time_frame>1 year</time_frame>
    <description>CESM to that of breast MRI in a population of women who are being screened because they are at increased risk for developing breast cancer. For this purpose a positive CESM test will be defined as a score of 4 or 5. We will use the existing MRI BIRADS system to score CESM images based on the characteristics of individual lesions and increased enhancement compared to the background. A positive MRI test will be defined by a BIRADs score of 4 or 5.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Women at Increased Risk for Developing Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>pts at risk for breast cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women at increased risk for breast cancer who are being referred for screening MRI will be offered and consented for CESM at the same time. The 2 examinations will be performed on the same day when at all possible and if not we will make every attempt to perform CESM before MRI. Patients with outside MRI performed within 30 days and of adequate quality will also be eligible for CESM.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mammography (CESM) and MRI</intervention_name>
    <description>The study consists of the addition of a single contrast enhanced digital mammography examination (CESM) to the routine screening of a woman at increased risk for breast cancer who is also having a breast MRI. Breast MRIs will be read by the radiologist reading breast MRIs on any given day. CESM is a dedicated system, derived from a standard digital mammography unit modified to deliver the dual or multiple energy exposures and visualization of combined images after IV contrast administration. If the patient is having her routine mammogram within 30 days of her MRI, CESM can replace that mammogram Patients will be randomly assigned to one of the radiologists trained to interpret CESM. That radiologist will read the CESM blinded to the results of the breast MRI.This process will be monitored by the research assistant No radiologist will read both the breast MRI and CESM on the same patient.</description>
    <arm_group_label>pts at risk for breast cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women considered at increased risk for developing breast carcinoma (those with a&#xD;
             lifetime risk of &gt;15%due to family history, genetic predisposition, prior radiation&#xD;
             therapy to the chest, prior biopsy showing a high risk lesion, or personal history of&#xD;
             breast cancer) that are being screened with breast MRI.&#xD;
&#xD;
          -  Women who have a screening digital mammogram on the day of CESM or within 365 days&#xD;
             prior&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women under 21.&#xD;
&#xD;
          -  Pregnant or possibly pregnant.&#xD;
&#xD;
          -  Women who have a contraindication to the intravenous use of iodinated - contrast agent&#xD;
             (i.e., allergy to iodinated contrastor severely impaired renal function with a&#xD;
             creatinine level &gt; or = to 1.3).&#xD;
&#xD;
          -  Women with breast implants.&#xD;
&#xD;
          -  Women with pacemakers.&#xD;
&#xD;
          -  Women with aneurysm clips that don't allow for MRI.&#xD;
&#xD;
          -  Women too claustrophobic to undergo MRI.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maxine Jochelson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>June 2018</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>June 18, 2018</last_update_submitted>
  <last_update_submitted_qc>June 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mammography (CESM)</keyword>
  <keyword>MRI</keyword>
  <keyword>Breast screening</keyword>
  <keyword>12-214</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/NCT01716247
org study id: 12-214
nct id: NCT01716247
lead sponsor: 
The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM)
      will be able to detect smaller/earlier breast cancers as well as breast MRI can.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: compare the sensitivity and specificity CESM
time frame: 1 year
description: CESM to that of breast MRI in a population of women who are being screened because they are at increased risk for developing breast cancer. For this purpose a positive CESM test will be defined as a score of 4 or 5. We will use the existing MRI BIRADS system to score CESM images based on the characteristics of individual lesions and increased enhancement compared to the background. A positive MRI test will be defined by a BIRADs score of 4 or 5.
arm group label: pts at risk for breast cancer
arm group type: Experimental
description: Women at increased risk for breast cancer who are being referred for screening MRI will be offered and consented for CESM at the same time. The 2 examinations will be performed on the same day when at all possible and if not we will make every attempt to perform CESM before MRI. Patients with outside MRI performed within 30 days and of adequate quality will also be eligible for CESM.
intervention type: Other
intervention name: Mammography (CESM) and MRI
description: The study consists of the addition of a single contrast enhanced digital mammography examination (CESM) to the routine screening of a woman at increased risk for breast cancer who is also having a breast MRI. Breast MRIs will be read by the radiologist reading breast MRIs on any given day. CESM is a dedicated system, derived from a standard digital mammography unit modified to deliver the dual or multiple energy exposures and visualization of combined images after IV contrast administration. If the patient is having her routine mammogram within 30 days of her MRI, CESM can replace that mammogram Patients will be randomly assigned to one of the radiologists trained to interpret CESM. That radiologist will read the CESM blinded to the results of the breast MRI.This process will be monitored by the research assistant No radiologist will read both the breast MRI and CESM on the same patient.
arm group label: pts at risk for breast cancer
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Maxine Jochelson, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Breast Neoplasms