The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Reconstructed Breast Volume
研究概览
简要总结
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Reconstructed Breast Volume
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Presence of Fat Necrosis in the Breast(up to 1 year after radiation)
- Evidence of Cancer Recurrence(up to 1 year after radiation)
- Symmetry(up to 1 year after radiation)
- Hyperpigmentation(up to 1 year after radiation)
- Contracture(up to 1 year after radiation)
- Aesthetic Result(up to 1 year after radiation)