Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Cardiac magnetic resonance (cardiac MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Left-sided breast cancer stage I-III. Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT). Women and men are allowed. Must be at least 18 years old at time of consent. Exclusion Criteria: Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study. Prior history of cardiovascular disease per physician discretion. Stage 0 and IV breast cancer. Prior radiation therapy to chest. Concurrent trastuzumab per physician discretion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac magnetic resonance (cardiac MRI)<br>Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy. | Procedure: Cardiac magnetic resonance (cardiac MRI)<br>* Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.<br>* Other names: CMR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with changes in cardiac function. | A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement. | 1 year after completion of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with serious cardiac side effects. | Includes myocardial infarction, valve disorder, congestive heart failure, and angina. | 1 year after completion of radiation therapy | 
| Mean quality of life score. | Comparison of baseline and post treatment quality of life questionnaires completed by participants. | 1 year after radiation treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac MRI, Radiation, Proton Radiation, Breast Cancer