Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation

Study Overview
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Brief Summary
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The association between radiation exposure and cardiac disease is well recognized, it is not fully understood if there exists an optimal or safe radiation dose-volume relationship.

Detailed Description
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Identification of safe dose volume constraints (DVC) for the heart from breast cancer radiotherapy would permit maximal oncologic benefit from radiation, identifying which patients require more complicated and resource consumptive radiation methods such as respiratory-gating or intensity modulated radiotherapy (IMRT) and establish patients who need targeted follow-up for their long term cardiac risk. Two recent technical developments now make it conceivable to identify the dose-volume relationship between heart dose and subsequent cardiac event risk: 1. CT based three dimensional conformal radiation delivery methods (3DCRT) where the precise radiation dose to any given heart volume is known, and 2. Cardiac MRI (CMR) that is more sensitive to prior methods of cardiac evaluation (e.g. SPECT) for detecting and measuring cardiac injury. An MRI, subject health questionnaire, clinical and dosimetric data will be included in the analysis.

Official Title
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Pilot Study to Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation in Women Treated for Node Positive Breast Cancer With Three- Dimensional Conformal Radiation Therapy (3DCRT)

Conditions
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Node Positive Breast Cancer

Intervention / Treatment
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* Radiation: Radiation therapy groups


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with node positive breast cancer treated with surgery, anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007. Exclusion Criteria: Women who have not received anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Radiation therapy groups<br>Risk groups based on dosimetric radiation parameters. | Radiation: Radiation therapy groups<br>* Radiation Therapy treatment between 2000 and 2007.<br>* Other names: Regional nodal irradiation following lumpectomy/mastectomy.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac MRI Parameters | Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE). | day of MRI scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate Cardiac MRI Parameters | Correlate cardiac MRI parameters with pre-treatment heart imaging and cardiac dose volume constraints as a measure of cardiac injury after partial heart irradiation in women with node positive breast cancer treated with surgery, anthracycline-based chemotherapy and regional nodal irradiation. | the day of MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer