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The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contract-enhanced MRI | Procedure | Patients will have contrast-enhanced MRI of the breasts. | ||
| Unilateral Adjuvant Radiation Therapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reconstructed Breast Volume | This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. | up to 1 year after radiation |
| Vascular Fibrosis | This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. | up to 1 year after radiation |
| Dermal Thickness | This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts | up to 1 year after radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Fat Necrosis in the Breast | This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. | up to 1 year after radiation |
| Evidence of Cancer Recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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The target population will consist of patients with a diagnosis of unilateral breast cancer who elect to undero bilateral mastectomy with immediate free flap reconstruction. Patients will be treated by members of the Division of Plastic and Reconstructive Surgery and will receive postoperative radiation therapy to the affected breast.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | 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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This will assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
| up to 1 year after radiation |
| Symmetry | This will be assessed at 2 points; before radiation and 1 year after radiation is completed between the 2 breasts. | up to 1 year after radiation |
| Hyperpigmentation | This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. | up to 1 year after radiation |
| Contracture | This will be assessed at 2 points:before radiation and 1 year after radiation is completed between the 2 breasts. | up to 1 year after radiation |
| Aesthetic Result | This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts. | up to 1 year after radiation |
| D017437 |
| Skin and Connective Tissue Diseases |