The Effects of Radiation in Reconstructed Breasts
2020年4月7日 更新者:Abramson Cancer Center of the University of Pennsylvania
The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
12
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Abramson Cancer Center of the University of Pennsylvania
-
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reconstructed Breast Volume
大体时间: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.
|
up to 1 year after radiation
|
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Vascular Fibrosis
大体时间: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.
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up to 1 year after radiation
|
|
Dermal Thickness
大体时间: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
|
up to 1 year after radiation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Presence of Fat Necrosis in the Breast
大体时间: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.
|
up to 1 year after radiation
|
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Evidence of Cancer Recurrence
大体时间: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.
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up to 1 year after radiation
|
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Symmetry
大体时间: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.
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up to 1 year after radiation
|
|
Hyperpigmentation
大体时间: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.
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up to 1 year after radiation
|
|
Contracture
大体时间: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.
|
up to 1 year after radiation
|
|
Aesthetic Result
大体时间: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.
|
up to 1 year after radiation
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年12月1日
初级完成 (实际的)
2016年12月1日
研究完成 (实际的)
2019年5月5日
研究注册日期
首次提交
2011年2月1日
首先提交符合 QC 标准的
2011年2月9日
首次发布 (估计)
2011年2月10日
研究记录更新
最后更新发布 (实际的)
2020年4月8日
上次提交的符合 QC 标准的更新
2020年4月7日
最后验证
2020年4月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- UPCC 12110
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