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| ID | Type | Description | Link |
|---|---|---|---|
| IRB201800163 | Other Identifier | UF IRB | |
| UFJ 2014-116 | Other Identifier | UF IRB Old Number |
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| Name | Class |
|---|---|
| Ocala Royal Dames | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac magnetic resonance (cardiac MRI) | Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac magnetic resonance (cardiac MRI) | Procedure | Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Radiation oncology clinic
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| Name | Affiliation | Role |
|---|---|---|
| Julie A Bradley, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Proton Therapy Institute | Jacksonville | Florida | 32206 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Comparison of baseline and post treatment quality of life questionnaires completed by participants.
| 1 year after radiation treatment |
| D017437 |
| Skin and Connective Tissue Diseases |