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/NCT06008301</url>
    </required_header>
    <id_info>
      <org_study_id>H-44009</org_study_id>
      <nct_id>NCT06008301</nct_id>
    </id_info>
    <brief_title>Comparing Breast Magnetic Resonance Imaging (MRI) and Contrast-enhanced Mammography (CEM)</brief_title>
    <official_title>Comparing Impact of Contrast-enhanced Mammography (CEM) to Breast MRI on Barriers to Breast Cancer Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boston Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Breast Cancer Alliance</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Boston Medical Center</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 investigators will study the financial, time, and psychologic benefit of Contrast&#xD;
        Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer&#xD;
        evaluation and ultimately encourage practices and referring providers to use it more&#xD;
        routinely in practice.&#xD;
  &#xD;
        Specific research objectives are to:&#xD;
  &#xD;
          -  determine financial costs of performing a CEM to breast MRI&#xD;
  &#xD;
          -  compare time costs involved with CEM to breast MRI&#xD;
  &#xD;
          -  compare psychologic costs involved with CEM to breast MRI.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Institutional financial costs</measure>
      <time_frame>24 months</time_frame>
      <description>True institutional costs will be calculated using time-driven activity based costing (TDABC) methodology to estimate the capacity cost rate (CCR, defined as cost per unit time in dollars per minute for personnel, equipment, and fixed equipment) and total cost (TC, defined as the sum of CCR per resource multiplied by time utilization and added to cost of consumable materials) for MRI and CEM.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient financial costs</measure>
      <time_frame>24 months</time_frame>
      <description>Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time from diagnosis to imaging modality (CEM or MRI)</measure>
      <time_frame>24 months</time_frame>
      <description>Time will be measured in days and abstracted from medical records.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time from diagnosis to first treatment</measure>
      <time_frame>24 months</time_frame>
      <description>Time will be measured in days and abstracted from medical records.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patient visits generated from the imaging modality</measure>
      <time_frame>24 months</time_frame>
      <description>Number of patient visits generated from the imaging modality will be abstracted from medical records.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Psychologic costs to patients</measure>
      <time_frame>24 months</time_frame>
      <description>The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from &quot;Almost Never&quot; to &quot;Almost Always&quot;). Higher scores indicate greater anxiety.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Breast Cancer Female</condition>
    <arm_group>
      <arm_group_label>Consent for the entire study</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with a newly diagnosed breast cancer and recommended for enhanced imaging will be randomly assigned to either CEM or MRI and take the State-Trait Anxiety Inventory (STAI) before and after imaging.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Consent only for the STAI</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants with a newly diagnosed breast cancer and recommended for enhanced imaging but who cannot or choose not to be randomly assigned to CEM or MRI but they consent to take the State-Trait Anxiety Inventory (STAI) before and after imaging.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>State-Trait Anxiety Inventory (STAI)</intervention_name>
      <description>The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.</description>
      <arm_group_label>Consent for the entire study</arm_group_label>
      <arm_group_label>Consent only for the STAI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; or equal to 30 years&#xD;
  &#xD;
            -  Clinically eligible for CEM or breast MRI&#xD;
  &#xD;
            -  Newly diagnosed cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant as verified by patient report. Given that this test is being performed for&#xD;
               clinical purposes, the determination of pregnancy status will be resolved via the&#xD;
               standard clinical pathway.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jordana Phillips, MD FSBI</last_name>
      <role>Principal Investigator</role>
      <affiliation>Boston Medical Center, Dept of Radiology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jordana Phillips, MD FSBI</last_name>
      <phone>(617) 638-6632</phone>
      <email>jordana.phillips@bmc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Artem Kaliaev, MD</last_name>
      <phone>617-851-2375</phone>
      <email>akaliaev@bu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Contrast enhanced mammography (CEM)</keyword>
    <keyword>Breast MRI</keyword>
    <keyword>Financial costs</keyword>
    <keyword>Time costs</keyword>
    <keyword>State-trait anxiety inventory (STAI)</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>No</sharing_ipd>
    </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/NCT06008301
  org study id: H-44009
  nct id: NCT06008301
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators will study the financial, time, and psychologic benefit of Contrast
        Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer
        evaluation and ultimately encourage practices and referring providers to use it more
        routinely in practice.
  
        Specific research objectives are to:
  
          -  determine financial costs of performing a CEM to breast MRI
  
          -  compare time costs involved with CEM to breast MRI
  
          -  compare psychologic costs involved with CEM to breast MRI.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Institutional financial costs
  time frame: 24 months
  description: True institutional costs will be calculated using time-driven activity based costing (TDABC) methodology to estimate the capacity cost rate (CCR, defined as cost per unit time in dollars per minute for personnel, equipment, and fixed equipment) and total cost (TC, defined as the sum of CCR per resource multiplied by time utilization and added to cost of consumable materials) for MRI and CEM.
  measure: Patient financial costs
  time frame: 24 months
  description: Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.
  measure: Time from diagnosis to imaging modality (CEM or MRI)
  time frame: 24 months
  description: Time will be measured in days and abstracted from medical records.
  measure: Time from diagnosis to first treatment
  time frame: 24 months
  description: Time will be measured in days and abstracted from medical records.
  measure: Number of patient visits generated from the imaging modality
  time frame: 24 months
  description: Number of patient visits generated from the imaging modality will be abstracted from medical records.
  measure: Psychologic costs to patients
  time frame: 24 months
  description: The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
  arm group label: Consent for the entire study
  arm group type: Experimental
  description: Participants with a newly diagnosed breast cancer and recommended for enhanced imaging will be randomly assigned to either CEM or MRI and take the State-Trait Anxiety Inventory (STAI) before and after imaging.
  arm group label: Consent only for the STAI
  arm group type: Active Comparator
  description: Participants with a newly diagnosed breast cancer and recommended for enhanced imaging but who cannot or choose not to be randomly assigned to CEM or MRI but they consent to take the State-Trait Anxiety Inventory (STAI) before and after imaging.
  intervention type: Other
  intervention name: State-Trait Anxiety Inventory (STAI)
  description: The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.
  arm group label: Consent for the entire study
  arm group label: Consent only for the STAI
  criteria: 
  gender: Female
  minimum age: 30 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jordana Phillips, MD FSBI
  role: Principal Investigator
  affiliation: Boston Medical Center, Dept of Radiology
  last name: Jordana Phillips, MD FSBI
  phone: (617) 638-6632
  email: jordana.phillips@bmc.org
  last name: Artem Kaliaev, MD
  phone: 617-851-2375
  email: akaliaev@bu.edu
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No