Breast Cancer
Conditions
Keywords
breast cancer, bilateral mastectomy, immediate breast reconstruction, locally advanced unilateral breast cancer, bilateral mastectomy for prophylaxis
Brief summary
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
Detailed description
Immediate breast reconstruction following mastectomy has become an increasingly popular and accepted treatment option among breast cancer patients. This change in practice has resulted in a significant number of patients who undergo radiation therapy after breast reconstruction. Following irradiation, the reconstructed breast often experiences fibrotic contracture, volume loss, altered pigmentation, or some combination thereof, producing an asymmetric and aesthetically compromised result. The effects of radiation on reconstructed breasts as well as the implications that such changes have for timing of reconstructive surgery, post-operative management and surveillance imaging are topics of growing importance in plastic surgery, radiology and surgical oncology.
Interventions
PROCEDUREcontract-enhanced MRI
Patients will have contrast-enhanced MRI of the breasts.
RADIATIONUnilateral Adjuvant Radiation Therapy
The study group will consist breasts receiving post-operative radiation, and the control group will consist of the patient's breasts on the non-radiated side. In this way, patients will act as their own control.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Female patients between 18 and 90 years of age. * Patients with a diagnosis of unilateral breast cancer who elect to undergo bilateral mastectomy with immediate free flap reconstruction. * Patients must also have a locally advanced tumor that requires adjuvant radiation therapy following reconstruction.
Exclusion criteria
* Women who do not undergo immediate, bilateral breast reconstruction using a free flap. * Women who do not require unilateral, adjuvant radiation therapy * Women who are pregnant * Women who have altered renal function, defined as a personal history of diabetic, hypertensive or autoimmune nephropathy and/or on routine preoperative testing are found to have a serum creatinine greater than or equal to 1.3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reconstructed Breast Volume | up to 1 year after radiation | This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. |
| Vascular Fibrosis | up to 1 year after radiation | This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. |
| Dermal Thickness | up to 1 year after radiation | This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperpigmentation | up to 1 year after radiation | This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. |
| Evidence of Cancer Recurrence | up to 1 year after radiation | This will assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. |
| Aesthetic Result | up to 1 year after radiation | This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. |
| Contracture | up to 1 year after radiation | This will be assessed at 2 points:before radiation and 1 year after radiation is completed between the 2 breasts. |
| Symmetry | up to 1 year after radiation | This will be assessed at 2 points; before radiation and 1 year after radiation is completed between the 2 breasts. |
| Presence of Fat Necrosis in the Breast | up to 1 year after radiation | This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. |
Countries
United States
Outcome results
None listed