The Effects of Radiation in Reconstructed Breasts

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: contract-enhanced MRI
* Radiation: Unilateral Adjuvant Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: contract-enhanced MRI|Patients will have contrast-enhanced MRI of the breasts.|
|Radiation: Unilateral 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, bilateral mastectomy, immediate breast reconstruction, locally advanced unilateral breast cancer, bilateral mastectomy for prophylaxis