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Comparison Study of Breast Computed Tomography (CT) With Magnetic Resonance Imaging (MRI)

2013年9月11日 更新者:Ioannis Sechopoulos, Ph.D.、Emory University

A Comparison Study of Contrast Enhanced Breast CT With MRI On Known Malignancies For Detection of Multifocal/Multicentric Disease

Lay Summary

After patients are diagnosed with breast cancer, they undergo breast magnetic resonance (MR) imaging to determine if the cancer is located in more than one place in the breast. Breast MR imaging is a good option for this test because it has very high sensitivity (catches almost all breast tumors). However, breast MR is slow: it takes about two minutes to acquire one image, and is very low resolution. The points that make up the breast MR image are around 1 to 3 mm in size.

Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. Combined with the use of special chemicals called iodine contrast enhancement, breast CT can provide images of both the anatomy and the blood flow in the breast. As opposed to breast MR, breast CT is very fast. An image can be taken in 10 seconds, and has very high resolution. The points in the breast CT image are only 0.14 mm in size. The investigators propose to use breast CT instead of breast MR imaging to determine if the patient's breast cancer is located in more than one place. This is the first time anybody has proposed to use breast CT for this, so the investigators aim to test the feasibility of the idea with only 6 patients.

Since the patients will undergo breast MR as part of the standard of care, the investigators will be able to compare the breast CT images to the current standard, breast MR. This work will lay a foundation for performing this very important test before breast cancer treatment planning with a new, fast, high resolution imaging method, breast CT.

研究概览

地位

完全的

条件

详细说明

See above

研究类型

观察性的

注册 (实际的)

2

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

    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University Hospital Breast Imaging Center

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

35年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

The target population for this study is women who have been diagnosed with breast cancer and have undergone breast MR imaging for detection of multifocal and/or multicentric tumors before undergoing treatment.

描述

3.1 Eligibility Criteria All subjects will be women at least 35 years of age that have been diagnosed with breast cancer and have undergone breast MR imaging for detection of multifocal/multicentric disease.

3.2 Ineligibility Criteria

  • Subject does not meet any of the inclusion criteria
  • Women with suspected or confirmed pregnancy
  • Women who have had bilateral mastectomy
  • Women who are very frail and unable to cooperate
  • Women who cannot give informed consent
  • Male subjects
  • Women with implants

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

队列和干预

团体/队列
Imaging
Women diagnosed with breast cancer having pre-treatment MRI for spread of disease

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Comparison of staging accuracy
大体时间:After biopsy
After biopsy

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:Ioannis Sechopoulos, PhD、Emory University

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

2009年6月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2012年1月1日

研究注册日期

首次提交

2009年8月11日

首先提交符合 QC 标准的

2009年8月11日

首次发布 (估计)

2009年8月12日

研究记录更新

最后更新发布 (估计)

2013年9月12日

上次提交的符合 QC 标准的更新

2013年9月11日

最后验证

2013年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB00014357

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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