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临床试验/NCT01666899
NCT01666899已完成不适用

Effect of Radiation on Tissue for Delayed Breast Reconstruction

University of Michigan Rogel Cancer Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.

研究概览

简要总结

The purpose of this study is to investigate the effects of radiation therapy following mastectomy on skin and blood vessels and to use information gathered to determine an ideal time for breast reconstruction after radiation.

详细描述

In the setting of post-mastectomy radiation therapy delayed autologous reconstruction, favored by many attempts to avoid complications encountered with radiating the immediately reconstructed breast. The timing of delayed reconstruction is however not known. The goal of this proposal is to study the gross, structural and vascular changes in radiated mastectomy skin in addition to possible structural and flow changes of the underlying internal mammary vessels over time. We plan to use these objective findings as a basis for determining an ideal time frame for delayed autologous breast reconstruction.

Sequential mastectomy skin specimens will be obtained from 20 patients undergoing post-mastectomy radiation therapy over a 24 month period and these specimens will be evaluated histologically. These same patients will also undergo serial examinations and photographic documentation of gross skin changes. Skin perfusion will be assessed by laser Doppler imaging and internal mammary vessel structure, and flow characteristics will be assessed by color Doppler sonography.

Based on these studies, we will elucidate short and long term changes in radiated breast skin, showing inflammatory, structural and perfusion patterns that can be correlated with optimal conditions for reconstruction. This has the potential to dramatically change practice patterns of delayed reconstruction for many reconstructive surgeons and more importantly restore what patients loose with mastectomy in a consistent, timely fashion. There is also potential for improved outcomes of delayed breast reconstruction by decreasing the number of reconstructions performed too soon after completion of radiation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy.
  • Patients who meet criteria 1, who plan on postmastectomy breast reconstruction

排除标准

  • Male patients
  • Patients under the age of 18
  • Patients of advanced age (greater than 75)
  • Patients with comorbidities that affect wound healing.

结局指标

主要结局

To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.

时间窗: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

次要结局

  • To evaluate the vascular density of the skin and perfusion changes following radiation therapy.(2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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