<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/NCT02199366</url>
  </required_header>
  <id_info>
    <org_study_id>UFPTI 1419-BR02</org_study_id>
    <secondary_id>IRB201800163</secondary_id>
    <secondary_id>UFJ 2014-116</secondary_id>
    <nct_id>NCT02199366</nct_id>
  </id_info>
  <brief_title>Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy</brief_title>
  <official_title>Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ocala Royal Dames</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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>
      This is a pilot study to determine if there are changes in heart function following&#xD;
      completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance&#xD;
      imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side&#xD;
      effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and&#xD;
      compare quality of life questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As part of this study, participants will have a cardiac MRI at baseline and a follow-up&#xD;
      cardiac MRI within 1 year after completion of standard radiation therapy for left-sided&#xD;
      breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in&#xD;
      cardiac function within 1 year after radiation treatment.&#xD;
&#xD;
      Patients will be asked to complete a questionnaire before and after treatment that asks about&#xD;
      their health and any symptoms they may be having.&#xD;
&#xD;
      Physical exams and any other standard of care service or treatment will be at the discretion&#xD;
      of the treating physician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">April 22, 2025</completion_date>
  <primary_completion_date type="Actual">July 7, 2021</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>Proportion of participants with changes in cardiac function.</measure>
    <time_frame>1 year after completion of radiation therapy</time_frame>
    <description>A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with serious cardiac side effects.</measure>
    <time_frame>1 year after completion of radiation therapy</time_frame>
    <description>Includes myocardial infarction, valve disorder, congestive heart failure, and angina.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean quality of life score.</measure>
    <time_frame>1 year after radiation treatment</time_frame>
    <description>Comparison of baseline and post treatment quality of life questionnaires completed by participants.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Cardiac magnetic resonance (cardiac MRI)</arm_group_label>
    <description>Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiac magnetic resonance (cardiac MRI)</intervention_name>
    <description>Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.</description>
    <arm_group_label>Cardiac magnetic resonance (cardiac MRI)</arm_group_label>
    <other_name>Cardiac MRI</other_name>
    <other_name>CMR</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Radiation oncology clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Left-sided breast cancer stage I-III.&#xD;
&#xD;
          -  Indications for adjuvant regional nodal and breast or chest wall radiation therapy&#xD;
             (RT).&#xD;
&#xD;
          -  Women and men are allowed.&#xD;
&#xD;
          -  Must be at least 18 years old at time of consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and/or breastfeeding women or patients of child-producing potential not&#xD;
             willing to use contraception while on study.&#xD;
&#xD;
          -  Prior history of cardiovascular disease per physician discretion.&#xD;
&#xD;
          -  Stage 0 and IV breast cancer.&#xD;
&#xD;
          -  Prior radiation therapy to chest.&#xD;
&#xD;
          -  Concurrent trastuzumab per physician discretion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie A Bradley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida Proton Therapy Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida Proton Therapy Institute</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac MRI</keyword>
  <keyword>Radiation</keyword>
  <keyword>Proton Radiation</keyword>
  <keyword>Breast Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Unilateral 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/NCT02199366
org study id: UFPTI 1419-BR02
secondary id: IRB201800163
secondary id: UFJ 2014-116
nct id: NCT02199366
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot study to determine if there are changes in heart function following
      completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance
      imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side
      effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and
      compare quality of life questionnaires.
As part of this study, participants will have a cardiac MRI at baseline and a follow-up
      cardiac MRI within 1 year after completion of standard radiation therapy for left-sided
      breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in
      cardiac function within 1 year after radiation treatment.

      Patients will be asked to complete a questionnaire before and after treatment that asks about
      their health and any symptoms they may be having.

      Physical exams and any other standard of care service or treatment will be at the discretion
      of the treating physician.
observational model: Cohort
time perspective: Prospective
measure: Proportion of participants with changes in cardiac function.
time frame: 1 year after completion of radiation therapy
description: A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.
measure: Proportion of patients with serious cardiac side effects.
time frame: 1 year after completion of radiation therapy
description: Includes myocardial infarction, valve disorder, congestive heart failure, and angina.
measure: Mean quality of life score.
time frame: 1 year after radiation treatment
description: Comparison of baseline and post treatment quality of life questionnaires completed by participants.
arm group label: Cardiac magnetic resonance (cardiac MRI)
description: Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.
intervention type: Procedure
intervention name: Cardiac magnetic resonance (cardiac MRI)
description: Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.
arm group label: Cardiac magnetic resonance (cardiac MRI)
other name: Cardiac MRI
other name: CMR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie A Bradley, MD
role: Principal Investigator
affiliation: University of Florida Proton Therapy Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Unilateral Breast Neoplasms