Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Radiation therapy groups Risk groups based on dosimetric radiation parameters. |
Radiation: Radiation therapy groups
Radiation Therapy treatment between 2000 and 2007.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Correlate Cardiac MRI Parameters [the day of MRI]
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.
Other Outcome Measures
- Dose-volume Constraints for the Heart During Radiation Therapy for Breast Cancer. [The day of the MRI]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Froedtert Hospital | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Medical College of Wisconsin
Investigators
- Principal Investigator: Carmen R Bergom, MD, PhD, Medical College of Wisconsin
Study Documents (Full-Text)
None provided.More Information
Publications
- Cardiac MRI post RT Breast Ca
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Radiation Therapy Groups |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Radiation Therapy Groups |
|---|---|
| Arm/Group Description | Risk groups based on dosimetric radiation parameters. Radiation therapy groups: Radiation Therapy treatment between 2000 and 2007. |
| Overall Participants | 20 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
14
70%
|
| >=65 years |
6
30%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
20
100%
|
| Male |
0
0%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| United States |
20
100%
|
Outcome Measures
| Title | Cardiac MRI Parameters |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Radiation Therapy Groups |
|---|---|
| Arm/Group Description | Risk groups based on dosimetric radiation parameters and eligibility criteria. Radiation therapy groups: Radiation Therapy treatment between 2000 and 2009. |
| Measure Participants | 20 |
| LGE |
0
|
| LVEF, more than 1% outside normal range |
0
|
| LV mass (indexed), higher than normal |
0
|
| LV chamber dimensions, higher than normal |
0
|
| Total Myocardial ECV, above 30% |
3
|
| Title | Correlate Cardiac MRI Parameters |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Dose-volume Constraints for the Heart During Radiation Therapy for Breast Cancer. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Radiation Therapy Groups | |
| Arm/Group Description | Risk groups based on dosimetric radiation parameters and eligibility criteria. Radiation therapy groups: Radiation Therapy treatment between 2000 and 2009. | |
All Cause Mortality |
||
| Radiation Therapy Groups | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Radiation Therapy Groups | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Radiation Therapy Groups | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Carmen Bergom |
|---|---|
| Organization | Medical College of Wisconsin |
| Phone | 414-805-4365 |
| cbergom@mcw.edu |
- Cardiac MRI post RT Breast Ca