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Effect of Radiation on Tissue for Delayed Breast Reconstruction

2017年5月24日 更新者:University of Michigan Rogel Cancer Center
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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

10

阶段

  • 不适用

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

    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan

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 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Skin and blood vessel procedures
All patients will be placed into Arm 1. They will undergo punch biopsies of the breast skin at the time of mastectomy and at 2, 4, 6, 8 and 12 months after completion of radiation therapy. Three more biopsies will be taken at 3, 6, and 12 months after completion of reconstruction. Patients will also undergo skin blood flow studies with a laser imaging device prior to each biopsy procedure. Ultrasound studies of the chest vessels will be performed 4 times over the course of the study- once prior to radiation and at 2, 6 and 12 months after radiation.
Biopsies, skin blood flow studies and ultrasound studies will be performed as described.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
大体时间:2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

次要结果测量

结果测量
大体时间
To evaluate the vascular density of the skin and perfusion changes following radiation therapy.
大体时间:2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

其他结果措施

结果测量
大体时间
To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.
大体时间:2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

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。

调查人员

  • 首席研究员:Adeyiza Momoh, MD、Univeristy of Michigan

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

2012年10月1日

初级完成 (实际的)

2015年6月15日

研究完成 (实际的)

2015年6月15日

研究注册日期

首次提交

2012年8月14日

首先提交符合 QC 标准的

2012年8月14日

首次发布 (估计)

2012年8月16日

研究记录更新

最后更新发布 (实际的)

2017年5月30日

上次提交的符合 QC 标准的更新

2017年5月24日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2012.032
  • HUM00059038 (其他标识符:University of Michigan Medical School IRB)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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