Node Positive Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
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
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.
Interventions
RADIATIONRadiation therapy groups
Radiation Therapy treatment between 2000 and 2007.
Sponsors
Medical College of Wisconsin
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac MRI Parameters | day of MRI scan | Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlate Cardiac MRI Parameters | the day of MRI | LVEF |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarmen R Bergom, MD, PhD
Medical College of Wisconsin
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiation Therapy Groups Risk groups based on dosimetric radiation parameters.
Radiation therapy groups: Radiation Therapy treatment between 2000 and 2007. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Radiation Therapy Groups |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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).
Time frame: day of MRI scan
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiation Therapy Groups | Cardiac MRI Parameters | LV mass (indexed), higher than normal | 0 number of patients |
| Radiation Therapy Groups | Cardiac MRI Parameters | LV chamber dimensions, higher than normal | 0 number of patients |
| Radiation Therapy Groups | Cardiac MRI Parameters | Total Myocardial ECV, above 30% | 3 number of patients |
| Radiation Therapy Groups | Cardiac MRI Parameters | LGE | 0 number of patients |
| Radiation Therapy Groups | Cardiac MRI Parameters | LVEF, more than 1% outside normal range | 0 number of patients |
Secondary
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.
Time frame: the day of MRI
Other Pre-specified
Dose-volume Constraints for the Heart During Radiation Therapy for Breast Cancer.
Trial data will improve the understanding of cardiac function after radiotherapy and allow oncologists to start to define safe dose-volume constraints for the heart in women treated with regional nodal irradiation for breast cancer.
Time frame: The day of the MRI