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临床试验/NCT00208871
NCT00208871已完成不适用

An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall

Emory University2 个研究点 分布在 1 个国家目标入组 1,467 人开始时间: 2004年12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
1,467
试验地点
2
主要终点
sensitivity/specificity

研究概览

简要总结

The primary goal of this study is to compare, within a clinical screening setting, the performance of stereoscopic digital mammography with standard (non-stereo) digital mammography in the detection of abnormalities in the breast, including early breast cancer.

详细描述

The clinical trial, begun in December, 2004, is being conducted at Emory University. Over the next three years, we will enroll and image about 2000 women who are at elevated risk for development of breast cancer (personal or family history of breast cancer) as they come in for their annual screening examinations. Each participating patient will be imaged with both systems, and the stereo and standard (non-stereo) images will be read independently by different mammographers.

A stereoscopic digital mammogram consists of two x-ray images of the breast acquired from slightly different points of view on a digital mammography unit. The x-ray source is rotated 10-degrees between the two exposures while the position of the breast remains fixed in the compression device. The stereo pair of mammograms is viewed on a new third-generation, high-resolution stereo display workstation that was developed in the first part of this project. The mammographer views the stereo display wearing lightweight polarized glasses, enabling him or her to see in depth the internal structure within the breast. As a result, a subtle lesion that may be obscured by superimposed normal tissue in a standard 2D image, now becomes visible as the overlying and underlying normal tissue is separated in depth. Conversely, layers of tissue that may falsely resemble a lesion in a standard 2D image due to chance superimposition, are seen in the stereo mammogram to lie at different depths and, thus, will not be mistaken as a lesion.

We anticipate that with stereo mammography the mammographers will detect subtle lesions in the stereo images that are missed in the non-stereo images. We also expect that there will be fewer false positive detections with the stereo images compared to the standard images. Finally, we also expect that the mammographers will be more confident in their judgments of what they see in the stereo images, resulting in a reduced rate of recall of patients for further work-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patient does not meet any of the inclusion criteria,
  • Patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy,
  • Patient has suspected or confirmed pregnancy,
  • Patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the GE Senographe 2000D digital mammography unit.

结局指标

主要结局

sensitivity/specificity

时间窗: Aug '04 to Dec '07

次要结局

  • Recall rate(Aug '04 to December '7)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carl J. D'Orsi, MD

Proffessor of Radiology & Hematology/Oncology

Emory University

研究点 (2)

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