Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)

Conditions
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Chemotherapy Induced Cardiotoxicity

Intervention / Treatment
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* Other: Cardiac magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with breast cancer Exclusion Criteria: Contraindication of MRI Failure with informed consent Fail to scan screening protocol

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br> | Other: Cardiac magnetic resonance imaging<br>* 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.<br>|
| Pretreatment group<br>Patients in pretreatment state | Other: Cardiac magnetic resonance imaging<br>* 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.<br>|
| Anthracycline-based chemotherapy (3 months)<br>Patients who received anthracycline-based chemotherapy 3 months ago | Other: Cardiac magnetic resonance imaging<br>* 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.<br>|
| Anthracycline-based chemotherapy (6 months)<br>Patients who received anthracycline-based chemotherapy 6 months ago | Other: Cardiac magnetic resonance imaging<br>* 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.<br>|
| Anthracycline-based chemotherapy (more than 1 year ago)<br>Patients who received anthracycline-based chemotherapy more than 1 year ago | Other: Cardiac magnetic resonance imaging<br>* 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.<br>|
| Other therapy group<br>Patients who have been treated with other therapies (other chemo-therapies, combined radiation therapy, target agent therapy, hormone therapy) | Other: Cardiac magnetic resonance imaging<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in LVEF (left ventricular ejection fraction) | Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50% | 1 year after CMR scanning | 
| Decrease in LVEF (left ventricular ejection fraction) | Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50% | 2 years after CMR scanning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (Major adverse cardiac events) |  | 1 year after CMR scanning | 
| MACE (Major adverse cardiac events) |  | 2 years after CMR scanning |