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Cardiac Effects From Radiation Therapy by MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486573
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : April 25, 2023
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Radiation Treatment Cancer Cardiotoxicity Diagnostic Test: Cardiac Magnetic Resonance Imaging Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identification of Early Cardiac Injury From Radiation Therapy Using Cardiac Magnetic Resonance Imaging
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : March 27, 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
CMRI

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.

 Diagnostic Test: Cardiac Magnetic Resonance Imaging
A cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart.


Outcome Measures
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Primary Outcome Measures :
  1. Change in myocardial strain [ Time Frame: 2 years ]
    Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT


Secondary Outcome Measures :
  1. T1 pre- and post-contrast values [ Time Frame: 2 years ]
    Measured by scans performed before and after RT

  2. Extracellular volume fraction [ Time Frame: 2 years ]
    Measured by scans performed before and after RT

  3. T2 values [ Time Frame: 2 years ]
    Measured by scans performed before and after RT

  4. Late gadolinium enhancement [ Time Frame: 2 years ]
    Measured by scans performed before and after RT

  5. Left ventricular ejection fraction [ Time Frame: 2 years ]
    Measured by scans performed before and after RT

  6. End diastolic volume [ Time Frame: 2 years ]
    Measured by scans performed before and after RT

  7. End systolic volume [ Time Frame: 2 years ]
    Measured by scans performed before and after RT

  8. Left atrial volume [ Time Frame: 2 years ]
    Measured by scans performed before and after RT

  9. Wall thickness [ Time Frame: 2 years ]
    Measured by scans performed before and after RT

  10. Left ventricular mass index [ Time Frame: 2 years ]
    Measured by scans performed before and after RT


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision to sign and date the consent form.
  2. Stated willingness to comply with all study procedures and be available for the duration of the study.
  3. 18 - 100 years of age
  4. KPS ≥ 70 or ECOG ≥ 1
  5. Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart
  6. Estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 Gy

Exclusion Criteria:

  1. Previous history of RT to the thorax or breast
  2. Implanted device that is non-MRI compatible or any implanted device in chest
  3. Known gadolinium contrast allergy or other contraindication to CMRI scan. Patients needing sedation or medication for claustrophobia or anxiety will not be excluded from participating.
  4. Found to be pregnant or breast-feeding
  5. Known history of atrial fibrillation or frequent ventricular or atrial premature beats
  6. Known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate < 60mL/min)
  7. History of coronary artery disease or myocardial disease
  8. History of hypertension, requiring >1 antihypertensive agent to maintain blood pressure <140/90
  9. Known history of valvular stenosis or regurgitation of > moderate severity
  10. Known history of heart failure (defined as baseline New York Heart Association Class III or IV (see Appendix A)
  11. Systolic blood pressure < 90mmGy
  12. Pulse < 50/minute
  13. Known history of pulmonary hypertension or elevated right ventricular systolic pressures.
  14. Suspicion or diagnosis of amyloidosis
  15. Suspicion or diagnosis of hemochromatosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486573


Contacts
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Contact: Chelsea Schaefer 17208480608 chelsea.schaefer@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Sarah Milgrom       sarah.milgrom@cuanschutz.edu   
Principal Investigator: Sarah Milgrom         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Sarah Milgrom University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04486573    
Other Study ID Numbers: 20-0537.cc
NCI-2020-06349 ( Other Identifier: CTRP )
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries