<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/NCT04486573</url>
  </required_header>
  <id_info>
    <org_study_id>20-0537.cc</org_study_id>
    <secondary_id>NCI-2020-06349</secondary_id>
    <nct_id>NCT04486573</nct_id>
  </id_info>
  <brief_title>Cardiac Effects From Radiation Therapy by MRI</brief_title>
  <official_title>Identification of Early Cardiac Injury From Radiation Therapy Using Cardiac Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</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 identify 10 patients in the department of radiation oncology who will&#xD;
      receive standard of-care radiation therapy, and the treating radiation oncologist anticipates&#xD;
      a mean left ventricular dose of at least 5 Gy. Patients will be evaluated by CMRI before and&#xD;
      within one week of the completion of RT. We will compare the pre- and post-RT CMRI scans to&#xD;
      identify changes related to radiation exposure. Our primary endpoint will be changes in&#xD;
      myocardial strain. Secondary endpoints will include other CMRI parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiac toxicity is a significant cause of morbidity and mortality in cancer survivors after&#xD;
      radiation therapy (RT) to the chest. Typically, cardiotoxicity is identified years after&#xD;
      radiation exposure. Emerging clinical data show that subclinical injury can be identified&#xD;
      immediately after treatment. Early identification of subclinical injury may enable&#xD;
      intervention to reduce the risk of progression to clinically significant toxicity. The&#xD;
      investigators hypothesize that cardiac magnetic resonance imaging (CMRI) will detect early&#xD;
      cardiac injury after RT and that imaging changes will be associated regionally with cardiac&#xD;
      radiation dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">March 27, 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in myocardial strain</measure>
    <time_frame>2 years</time_frame>
    <description>Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>T1 pre- and post-contrast values</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extracellular volume fraction</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T2 values</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late gadolinium enhancement</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular ejection fraction</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End diastolic volume</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End systolic volume</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left atrial volume</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wall thickness</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular mass index</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by scans performed before and after RT</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Radiation Treatment</condition>
  <condition>Cancer</condition>
  <condition>Cardiotoxicity</condition>
  <arm_group>
    <arm_group_label>CMRI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Clinical data will be collected regarding cardiac risk factors, cancer type, and cancer treatment.&#xD;
CMRI will be performed:&#xD;
Within 2 weeks before the first fraction of radiation therapy (RT)&#xD;
Within 1 week of the final fraction of RT (before or after)&#xD;
Any patient with a pre-RT and post-RT MRI scan will be considered evaluable.&#xD;
Pre- and post-RT CMRI parameters will be compared.&#xD;
3D reconstructed CMR images will be co-registered with RT treatment plans to assess for spatial associations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiac Magnetic Resonance Imaging</intervention_name>
    <description>A cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart.</description>
    <arm_group_label>CMRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision to sign and date the consent form.&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures and be available for the&#xD;
             duration of the study.&#xD;
&#xD;
          3. 18 - 100 years of age&#xD;
&#xD;
          4. KPS ≥ 70 or ECOG ≥ 1&#xD;
&#xD;
          5. Will receive RT using computed tomography (CT)-based treatment planning that will&#xD;
             involve delivery of dose to the heart&#xD;
&#xD;
          6. Estimated by the treating radiation oncologist at the time of simulation to have a&#xD;
             mean left ventricular dose of at least 5 Gy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous history of RT to the thorax or breast&#xD;
&#xD;
          2. Implanted device that is non-MRI compatible or any implanted device in chest&#xD;
&#xD;
          3. Known gadolinium contrast allergy or other contraindication to CMRI scan. Patients&#xD;
             needing sedation or medication for claustrophobia or anxiety will not be excluded from&#xD;
             participating.&#xD;
&#xD;
          4. Found to be pregnant or breast-feeding&#xD;
&#xD;
          5. Known history of atrial fibrillation or frequent ventricular or atrial premature beats&#xD;
&#xD;
          6. Known history of chronic kidney disease (such as, but not limited, to a glomerular&#xD;
             filtration rate &lt; 60mL/min)&#xD;
&#xD;
          7. History of coronary artery disease or myocardial disease&#xD;
&#xD;
          8. History of hypertension, requiring &gt;1 antihypertensive agent to maintain blood&#xD;
             pressure &lt;140/90&#xD;
&#xD;
          9. Known history of valvular stenosis or regurgitation of &gt; moderate severity&#xD;
&#xD;
         10. Known history of heart failure (defined as baseline New York Heart Association Class&#xD;
             III or IV (see Appendix A)&#xD;
&#xD;
         11. Systolic blood pressure &lt; 90mmGy&#xD;
&#xD;
         12. Pulse &lt; 50/minute&#xD;
&#xD;
         13. Known history of pulmonary hypertension or elevated right ventricular systolic&#xD;
             pressures.&#xD;
&#xD;
         14. Suspicion or diagnosis of amyloidosis&#xD;
&#xD;
         15. Suspicion or diagnosis of hemochromatosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Milgrom</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chelsea Schaefer</last_name>
    <phone>17208480608</phone>
    <email>chelsea.schaefer@cuanschutz.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Milgrom</last_name>
      <email>sarah.milgrom@cuanschutz.edu</email>
    </contact>
    <investigator>
      <last_name>Sarah Milgrom</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</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/NCT04486573
org study id: 20-0537.cc
secondary id: NCI-2020-06349
nct id: NCT04486573
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators will identify 10 patients in the department of radiation oncology who will
      receive standard of-care radiation therapy, and the treating radiation oncologist anticipates
      a mean left ventricular dose of at least 5 Gy. Patients will be evaluated by CMRI before and
      within one week of the completion of RT. We will compare the pre- and post-RT CMRI scans to
      identify changes related to radiation exposure. Our primary endpoint will be changes in
      myocardial strain. Secondary endpoints will include other CMRI parameters.
Cardiac toxicity is a significant cause of morbidity and mortality in cancer survivors after
      radiation therapy (RT) to the chest. Typically, cardiotoxicity is identified years after
      radiation exposure. Emerging clinical data show that subclinical injury can be identified
      immediately after treatment. Early identification of subclinical injury may enable
      intervention to reduce the risk of progression to clinically significant toxicity. The
      investigators hypothesize that cardiac magnetic resonance imaging (CMRI) will detect early
      cardiac injury after RT and that imaging changes will be associated regionally with cardiac
      radiation dose.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in myocardial strain
time frame: 2 years
description: Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT
measure: T1 pre- and post-contrast values
time frame: 2 years
description: Measured by scans performed before and after RT
measure: Extracellular volume fraction
time frame: 2 years
description: Measured by scans performed before and after RT
measure: T2 values
time frame: 2 years
description: Measured by scans performed before and after RT
measure: Late gadolinium enhancement
time frame: 2 years
description: Measured by scans performed before and after RT
measure: Left ventricular ejection fraction
time frame: 2 years
description: Measured by scans performed before and after RT
measure: End diastolic volume
time frame: 2 years
description: Measured by scans performed before and after RT
measure: End systolic volume
time frame: 2 years
description: Measured by scans performed before and after RT
measure: Left atrial volume
time frame: 2 years
description: Measured by scans performed before and after RT
measure: Wall thickness
time frame: 2 years
description: Measured by scans performed before and after RT
measure: Left ventricular mass index
time frame: 2 years
description: Measured by scans performed before and after RT
arm group label: CMRI
arm group type: Other
description: Clinical data will be collected regarding cardiac risk factors, cancer type, and cancer treatment.
CMRI will be performed:
Within 2 weeks before the first fraction of radiation therapy (RT)
Within 1 week of the final fraction of RT (before or after)
Any patient with a pre-RT and post-RT MRI scan will be considered evaluable.
Pre- and post-RT CMRI parameters will be compared.
3D reconstructed CMR images will be co-registered with RT treatment plans to assess for spatial associations.
intervention type: Diagnostic Test
intervention name: Cardiac Magnetic Resonance Imaging
description: A cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart.
arm group label: CMRI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Sarah Milgrom
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Chelsea Schaefer
phone: 17208480608
email: chelsea.schaefer@cuanschutz.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Cardiotoxicity
sharing ipd: No