<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/NCT03301389</url>
  </required_header>
  <id_info>
    <org_study_id>4-2016-0730</org_study_id>
    <nct_id>NCT03301389</nct_id>
  </id_info>
  <brief_title>Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)</brief_title>
  <official_title>Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      Chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in&#xD;
      patients with cancer. The clinical significance of cardiotoxicity is growing with increasing&#xD;
      cancer survivor-ship.&#xD;
&#xD;
      Left ventricular (LV) functional assessment is the standard of reference to diagnose&#xD;
      chemotherapy- or radiation therapy-induced cardiotoxicity. The investigators will investigate&#xD;
      the usefulness of T1 mapping parameters for early detection and prediction of chemotherapy-,&#xD;
      radiation therapy-, or other therapy-induced cardiotoxicity in breast cancer patients This&#xD;
      study aimed to achieve early detection of chemotherapy- or radiation therapy-induced&#xD;
      cardiotoxicity using T1 mapping magnetic resonance imaging (MRI) and determine a prognostic&#xD;
      imaging factor of chemotherapy- or radiation therapy-induced cardiotoxicity in patients&#xD;
      treated for breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening and follow-up cardiac magnetic resonance imaging (CMR) protocols for diagnosis of&#xD;
      cardiotoxicity will be conducted in patients with breast cancer who have received or are&#xD;
      planned to receive treatment for breast cancer. The protocol will include T1 and T2 mapping&#xD;
      and cine imaging of the LV myocardium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>Decrease in LVEF (left ventricular ejection fraction)</measure>
    <time_frame>1 year after CMR scanning</time_frame>
    <description>Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF &lt; 50%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decrease in LVEF (left ventricular ejection fraction)</measure>
    <time_frame>2 years after CMR scanning</time_frame>
    <description>Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF &lt; 50%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MACE (Major adverse cardiac events)</measure>
    <time_frame>1 year after CMR scanning</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE (Major adverse cardiac events)</measure>
    <time_frame>2 years after CMR scanning</time_frame>
  </secondary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Chemotherapy Induced Cardiotoxicity</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Pretreatment group</arm_group_label>
    <description>Patients in pretreatment state</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anthracycline-based chemotherapy (3 months)</arm_group_label>
    <description>Patients who received anthracycline-based chemotherapy 3 months ago</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anthracycline-based chemotherapy (6 months)</arm_group_label>
    <description>Patients who received anthracycline-based chemotherapy 6 months ago</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anthracycline-based chemotherapy (more than 1 year ago)</arm_group_label>
    <description>Patients who received anthracycline-based chemotherapy more than 1 year ago</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other therapy group</arm_group_label>
    <description>Patients who have been treated with other therapies (other chemo-therapies, combined radiation therapy, target agent therapy, hormone therapy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiac magnetic resonance imaging</intervention_name>
    <description>The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.</description>
    <arm_group_label>Anthracycline-based chemotherapy (3 months)</arm_group_label>
    <arm_group_label>Anthracycline-based chemotherapy (6 months)</arm_group_label>
    <arm_group_label>Anthracycline-based chemotherapy (more than 1 year ago)</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Other therapy group</arm_group_label>
    <arm_group_label>Pretreatment group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The breast cancer patient with pretreatment state The breast cancer patients with the prior&#xD;
        chemotherapy, or radiation therapy The breast cancer patients receiving prior chemotherapy,&#xD;
        or radiation therapy The breast cancer patients with other treatments&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication of MRI&#xD;
&#xD;
          -  Failure with informed consent&#xD;
&#xD;
          -  Fail to scan screening protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Byoung Wook Choi, MD</last_name>
      <phone>82-2228-7400</phone>
      <email>bchoi@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</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>Cardiotoxicity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03301389
org study id: 4-2016-0730
nct id: NCT03301389
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in
      patients with cancer. The clinical significance of cardiotoxicity is growing with increasing
      cancer survivor-ship.

      Left ventricular (LV) functional assessment is the standard of reference to diagnose
      chemotherapy- or radiation therapy-induced cardiotoxicity. The investigators will investigate
      the usefulness of T1 mapping parameters for early detection and prediction of chemotherapy-,
      radiation therapy-, or other therapy-induced cardiotoxicity in breast cancer patients This
      study aimed to achieve early detection of chemotherapy- or radiation therapy-induced
      cardiotoxicity using T1 mapping magnetic resonance imaging (MRI) and determine a prognostic
      imaging factor of chemotherapy- or radiation therapy-induced cardiotoxicity in patients
      treated for breast cancer.
Screening and follow-up cardiac magnetic resonance imaging (CMR) protocols for diagnosis of
      cardiotoxicity will be conducted in patients with breast cancer who have received or are
      planned to receive treatment for breast cancer. The protocol will include T1 and T2 mapping
      and cine imaging of the LV myocardium.
observational model: Cohort
time perspective: Prospective
measure: Decrease in LVEF (left ventricular ejection fraction)
time frame: 1 year after CMR scanning
description: Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50%
measure: Decrease in LVEF (left ventricular ejection fraction)
time frame: 2 years after CMR scanning
description: Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50%
measure: MACE (Major adverse cardiac events)
time frame: 1 year after CMR scanning
measure: MACE (Major adverse cardiac events)
time frame: 2 years after CMR scanning
arm group label: Control group
arm group label: Pretreatment group
description: Patients in pretreatment state
arm group label: Anthracycline-based chemotherapy (3 months)
description: Patients who received anthracycline-based chemotherapy 3 months ago
arm group label: Anthracycline-based chemotherapy (6 months)
description: Patients who received anthracycline-based chemotherapy 6 months ago
arm group label: Anthracycline-based chemotherapy (more than 1 year ago)
description: Patients who received anthracycline-based chemotherapy more than 1 year ago
arm group label: Other therapy group
description: Patients who have been treated with other therapies (other chemo-therapies, combined radiation therapy, target agent therapy, hormone therapy)
intervention type: Other
intervention name: Cardiac magnetic resonance imaging
description: The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.
arm group label: Anthracycline-based chemotherapy (3 months)
arm group label: Anthracycline-based chemotherapy (6 months)
arm group label: Anthracycline-based chemotherapy (more than 1 year ago)
arm group label: Control group
arm group label: Other therapy group
arm group label: Pretreatment group
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 17 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Cardiotoxicity
sharing ipd: No