<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/NCT03008031</url>
  </required_header>
  <id_info>
    <org_study_id>162048</org_study_id>
    <nct_id>NCT03008031</nct_id>
  </id_info>
  <brief_title>Reduced Contrast Administration in Contrast-enhanced Spectral Mammography (CESM)</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The optimal dose of iodine based contrast agents used in contrast-enhanced spectral&#xD;
      mammography (CESM) is unknown. If CESM, performed with lower dose of iodine based contrast&#xD;
      agent, visualizes a tumor comparable to CESM with regular dose of contrast agent, patients&#xD;
      can receive less contrast agent for CESM in future and thereby risking less side effects of&#xD;
      the contrast agent.&#xD;
&#xD;
      In order to study whether CESM remains unchanged at smaller amounts of contrast&#xD;
      administration, a second CESM exam will be performed within one week of the first with a an&#xD;
      alternative amount of contrast, it being either 80%, 60% or 40% of the original contrast&#xD;
      dose. The settings of the CESM unit will remain unchanged.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">April 2020</completion_date>
  <primary_completion_date type="Actual">April 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of maximum tumor size measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations.</measure>
    <time_frame>After completion of final patient inclusion (e.g. 1 year)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Enhancement measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations.</measure>
    <time_frame>After completion of final patient inclusion (e.g. 1 year)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Breast Neoplasm</condition>
  <condition>Contrast-enhanced Spectral Mammography</condition>
  <arm_group>
    <arm_group_label>arm A (40%)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized in arm A will receive a second CESM exam with 40% of the initial dose of the contrast agent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm B (60%)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized in arm A will receive a second CESM exam with 60% of the initial dose of the contrast agent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm C (80%)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized in arm A will receive a second CESM exam with 80% of the initial dose of the contrast agent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CESM with a reduced dose of contrast agent</intervention_name>
    <arm_group_label>arm A (40%)</arm_group_label>
    <arm_group_label>arm B (60%)</arm_group_label>
    <arm_group_label>arm C (80%)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patient with histopathologically confirmed invasive breast cancer who recently&#xD;
             underwent a clinical CESM exam without complications;&#xD;
&#xD;
          -  Treated with primary surgery;&#xD;
&#xD;
          -  Willing and able to undergo all study procedures;&#xD;
&#xD;
          -  Has personally provided written informed consent.&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Allergy for any of the ingredients of (Ultravist) contrast agent&#xD;
&#xD;
          -  Being unable to give informed consent in person&#xD;
&#xD;
          -  History of coronary arterial disease or unstable angina&#xD;
&#xD;
          -  Acute or chronic severe renal insufficiency&#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>Marc BI Lobbes, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thiemo JA van Nijnatten, MD, PhD</last_name>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03008031
org study id: 162048
nct id: NCT03008031
lead sponsor: 
has dmc: Yes
The optimal dose of iodine based contrast agents used in contrast-enhanced spectral
      mammography (CESM) is unknown. If CESM, performed with lower dose of iodine based contrast
      agent, visualizes a tumor comparable to CESM with regular dose of contrast agent, patients
      can receive less contrast agent for CESM in future and thereby risking less side effects of
      the contrast agent.

      In order to study whether CESM remains unchanged at smaller amounts of contrast
      administration, a second CESM exam will be performed within one week of the first with a an
      alternative amount of contrast, it being either 80%, 60% or 40% of the original contrast
      dose. The settings of the CESM unit will remain unchanged.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Accuracy of maximum tumor size measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations.
time frame: After completion of final patient inclusion (e.g. 1 year)
measure: Enhancement measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations.
time frame: After completion of final patient inclusion (e.g. 1 year)
arm group label: arm A (40%)
arm group type: Experimental
description: Patients randomized in arm A will receive a second CESM exam with 40% of the initial dose of the contrast agent.
arm group label: arm B (60%)
arm group type: Experimental
description: Patients randomized in arm A will receive a second CESM exam with 60% of the initial dose of the contrast agent.
arm group label: arm C (80%)
arm group type: Experimental
description: Patients randomized in arm A will receive a second CESM exam with 80% of the initial dose of the contrast agent.
intervention type: Procedure
intervention name: CESM with a reduced dose of contrast agent
arm group label: arm A (40%)
arm group label: arm B (60%)
arm group label: arm C (80%)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc BI Lobbes, MD, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
last name: Thiemo JA van Nijnatten, MD, PhD
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Breast Neoplasms