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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy groups | Risk groups based on dosimetric radiation parameters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation therapy groups | Radiation | Radiation Therapy treatment between 2000 and 2007. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate Cardiac MRI Parameters | LVEF | the day of MRI |
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Inclusion Criteria:
Exclusion Criteria:
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Women Treated for Node Positive Breast Cancer with Three-Dimensional Conformal Radiation Therapy (3DCRT)
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| Name | Affiliation | Role |
|---|---|---|
| Carmen R Bergom, MD, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17112987 | Background | Assomull RG, Prasad SK, Lyne J, Smith G, Burman ED, Khan M, Sheppard MN, Poole-Wilson PA, Pennell DJ. Cardiovascular magnetic resonance, fibrosis, and prognosis in dilated cardiomyopathy. J Am Coll Cardiol. 2006 Nov 21;48(10):1977-85. doi: 10.1016/j.jacc.2006.07.049. Epub 2006 Oct 31. |
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Data available upon request after publication of findings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy Groups | Risk groups based on dosimetric radiation parameters and eligibility criteria. Radiation therapy groups: 3D Conformal Radiation Therapy (3DCRT) to breast/chestwall and regional lymph nodes with treatment between 2000 and 2009. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy Groups | Risk groups based on dosimetric radiation parameters. Radiation therapy groups: Radiation Therapy treatment between 2000 and 2007. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | number of patients | day of MRI scan |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiation Therapy Groups | Risk groups based on dosimetric radiation parameters and eligibility criteria. Radiation therapy groups: Radiation Therapy treatment between 2000 and 2009. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carmen Bergom | Medical College of Wisconsin | 414-805-4365 | cbergom@mcw.edu |
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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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| ID | Term |
|---|---|
| D008408 | Mastectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Correlate Cardiac MRI Parameters | LVEF | Study participants | Posted | Median | Full Range | LVEF % | the day of MRI |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
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| D017437 |
| Skin and Connective Tissue Diseases |