Low dose digital X-rays for mammographic screening

描述(由申请人提供)： 乳腺癌目前占全球所有癌症的9%，而在美国，32%的癌症发病率和18%的癌症死亡是乳腺癌造成的。尽管最近大众媒体的报道对乳房X光检查的益处提出了质疑，但科学文献是明确的：在过去的十年里，乳腺癌的早期发现和治疗使死亡率降低了20%。尽管目前的屏幕-胶片乳房X光检查系统取得了成功，占全球所有设备的95%以上，但它们确实存在一些缺陷。该项目的长期目标是通过开发一种建立在南非创造的创新医学成像技术基础上的数字乳房X光摄影系统来解决这些缺点。具体地说，我们的目标是开发一种具有以下重要功能的系统：(1)显著降低患者和医护人员的辐射暴露；(2)通过调制传递函数(MTF)和检测量子效率(DQE)验证卓越的图像质量；(3)通过减少痛苦的乳房压迫来改善患者的舒适度；(4)扩大乳房解剖的覆盖面，从而减少漏诊；(5)提供基于数字图像的计算机辅助诊断(CAD)；以及(6)减少在检查室花费的时间，从而增加患者的吞吐量。该项目将有两个重叠的阶段。在第一阶段，将设计、建造和测试数字乳房X光照相系统的原型。我们将通过采用最近被食品和药物管理局批准用于全身创伤应用的专利缝隙扫描技术，在保持图像质量的同时减少辐射暴露。固态图像传感器将被纳入X射线探测器的设计中，以最大限度地提高信噪比。除了测量剂量和检测微小病变的人体模型研究外，还将进行MTF和DQE的仔细研究。通过考虑乳房解剖的运动扫描，可以减少对乳房压迫的需要，并覆盖更多的乳房组织，从而提高患者的舒适度。由于图像将是数字形式的，这将方便CAD应用程序，同时也减少了患者检查时间。在项目第二阶段的最后6个月，我们将对20名患者进行有限的临床试验，重点是舒适度、乳房覆盖率和诊断等价性。

DESCRIPTION (provided by applicant): Breast cancer currently accounts for 9% of all cancers worldwide, while in the United States 32% of cancer incidence and 18% of cancer deaths are a result of breast carcinoma. Although recent reports in the popular media have called into question the benefits of mammographic screening, the scientific literature is clear: early detection and treatment of breast cancer have yielded a 20% reduction in the mortality rate in the past decade. Despite the success of current screen-film mammography systems, which account for more than 95% of all units worldwide, they do suffer from a number of drawbacks. The long-term objective of this project is to address these drawbacks by developing a digital mammography system built on innovative medical imaging technologies that have been created in South Africa. Specifically, our aim is to develop a system with the following important features: (1) significantly lower radiation exposure for both patients and healthcare workers; (2) outstanding image quality verified by modulation transfer function (MTF) and detective quantum efficiency (DQE); (3) improved patient comfort through the reduction of painful breast compression; (4) greater coverage of breast anatomy, resulting in fewer missed diagnoses; (5) the provision of computer-assisted diagnosis (CAD) based on the digital images; and (6) reduced time spent in the exam room, leading to increased patient throughput. There will be two overlapping phases to the project. In phase 1, a prototype digital mammography system will be designed, built and tested. We will reduce radiation exposure while maintaining image quality by incorporating a patented slot scanning technique that has recently been approved for whole-body trauma applications by the Food and Drug Administration. Solid-state image sensors will be incorporated in the design of the X-ray detectors, maximizing the signal-to-noise ratio. A careful study of MTF and DQE will be conducted, in addition to manikin phantom studies to measure dose and detection of small lesions. By scanning in a motion that accounts for breast anatomy, it will be possible to improve patient comfort by reducing the need for breast compression and also covering a greater volume of breast tissue. Because the images will be in digital form, this will facilitate CAD applications while also reducing patient examination time. During the last 6 months of the project in phase 2, we will conduct a limited clinical trial of 20 patients, focusing on comfort, breast coverage and diagnostic equivalence.