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Breast CT scanner for earlier cancer detection

用于早期癌症检测的乳房 CT 扫描仪

基本信息

批准号：
7114357
负责人：
JOHN M BOONE
金额：
$ 85.35万
依托单位：
UNIVERSITY OF CALIFORNIA AT DAVIS
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-09-01 至 2008-05-31
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): Breast cancer is a disease with high incidence in the U.S. and elsewhere, and population-level methods of fighting this disease are aimed primarily on screening, using mammography for early detection. The median size of breast cancer found using mammography is approximately 11 mm. Based on extensive preliminary studies involving computer simulations, physical measurements, and cadaver breast imaging, we have found that breast CT may be able to routinely detect much smaller breast tumors, in the 3 to 5 mm range. Importantly, the radiation dose of breast CT performed at 80 kVp was found in detailed studies to be comparable to that of mammography. It is not possible to image the breast alone on a live woman using a clinical CT scanner. Therefore, in this Bioengineering Research Partnership proposal, we have teamed with scientists from around the country to design, build, and test a CT scanner designed to image the breast. A team comprised of medical physicists, physicians, mechanical and electrical engineers, and breast cancer advocates will collaborate on the design of the breast CT scanner. Cone beam flat panel technology will be used to produce a scanner capable of 10 second breast scanning, and the scanner development will also include a breast immobilization system (acrylic cylinders), a breast CT table, a fast reconstruction computer, and a computer workstation customized for efficient viewing breast CT images. The scanner will be built, tested, and optimized at UC Davis over a period of 3 years involving 9 specific aims. After the breast CT scanner is tested in a brief phase I trial (2 specific aims), it will be moved to the breast imaging clinic for a phase II trial where approximately 120 women will be imaged (4 specific aims). This phase II trial will evaluate the efficacy of breast CT for the early detection of breast cancer in a group of women likely to have breast cancer (BIRADS 4 & 5). Additionally, the breast image data will be studied for its utility in automating the analysis of the normal breast architecture, and for computerized cancer detection. In year 5 of the proposed research, two specific aims utilize the breast CT data and corresponding mammography images (on -240 breasts) to evaluate the ideal observer performance and human (mammographer) detection performance attributes of the breast CT scanner. At the end of the proposed research involving 17 specific aims, the potential of breast CT will have been evaluated both qualitatively and quantitatively. A tested, high quality prototype breast CT scanner would be ready to be enlisted in a phase III trial (beyond the scope of this proposed research), if further testing is warranted. Performance data acquired in the present study would allow the proper design (power, etc.) of a phase III trial. If breast CT lives up to its enormous potential based on initial imaging, breast cancer would be detectable far before metastases occurs - for example, a 3 mm tumor contains only 2 percent of the cell count of an 11 mm lesion, and a 5 mm lesion contains only 9 percent of the cell count. Based on a 100 day volume doubling time, detection of a 5 mm lesion would lead to 0.93 year earlier detection, and routine detection of 3 mm lesions would result in 1.5 year earlier detection over mammography. Surgical removal of early cancers will effectively result in cure for the majority of women screened using this technology. While breast CT would probably improve cancer detection in all women, some women may have risk factors (dense breasts, genetic markers, etc.) that particularly warrant screening using breast CT. The Phase II trial will shed more light on this issue.

描述（由申请人提供）：乳腺癌是一种发病率较高的疾病。美国和其他地方的发病率以及人群层面的战斗方法这种疾病的主要目的是筛查，使用乳房X光检查进行早期筛查检测。使用乳房X光检查发现的乳腺癌的中位大小是约11毫米。基于涉及计算机的广泛初步研究通过模拟、物理测量和尸体乳房成像，我们发现乳腺 CT 可能能够常规检测出更小的乳腺肿瘤 3 至 5 毫米范围。重要的是，乳腺 CT 的辐射剂量在详细研究发现 80 kVp 与乳房 X 光检查相当。使用临床技术不可能单独对活体女性的乳房进行成像 CT 扫描仪。因此，在这个生物工程研究合作伙伴提案中，我们与来自全国各地的科学家合作设计、建造和测试设计用于乳房成像的 CT 扫描仪。由医疗人员组成的团队物理学家、医生、机械和电气工程师以及乳腺癌倡导者将合作设计乳腺 CT 扫描仪。锥束平板技术将用于生产能够 10 秒扫描的扫描仪乳房扫描，扫描仪的开发还将包括乳房扫描固定系统（丙烯酸圆柱体）、乳房 CT 台、快速重建计算机，为高效定制的计算机工作站查看乳房 CT 图像。扫描仪将在以下时间构建、测试和优化：加州大学戴维斯分校历时 3 年，涉及 9 个具体目标。丰胸后 CT 扫描仪在简短的第一阶段试验中进行了测试（2 个具体目标），它将转移到乳腺成像诊所进行 II 期试验，其中大约 120 女性将被成像（4 个具体目标）。该 II 期试验将评估乳腺CT对乳腺癌早期发现的效果女性可能患有乳腺癌（BIRADS 4 和 5）。另外，乳房将研究图像数据在自动化分析中的实用性正常乳房结构，以及用于计算机化癌症检测。在第 5 年拟议的研究有两个具体目标，即利用乳腺 CT 数据和相应的乳房 X 光检查图像（-240 乳房）以评估理想情况观察者性能和人类（乳房 X 光检查人员）检测性能属性乳腺 CT 扫描仪。在拟议的研究结束时，涉及 17 根据具体目标，乳腺 CT 的潜力将得到评估定性和定量。经过测试的高质量乳房 CT 原型扫描仪将准备好参加 III 期试验（超出了如果需要进一步测试，则建议进行这项研究）。性能数据本研究中获得的信息将允许正确设计（功率等） III 期试验。如果乳腺 CT 能够发挥其巨大潜力初始成像，乳腺癌在转移发生之前就可以被检测到 - 例如，一个 3 毫米的肿瘤仅包含 11 毫米肿瘤的细胞计数的 2% 毫米的病灶，而 5 毫米的病灶仅包含 9% 的细胞计数。基于在 100 天的体积倍增时间内，检测到 5 毫米的病变将导致提早0.93年检测，常规检测3毫米病变即可比乳房X光检查提前1.5年检测到。早期手术切除大多数接受筛查的女性将有效治愈癌症使用这项技术。虽然乳腺 CT 可能会改善癌症检测在所有女性中，有些女性可能有危险因素（致密的乳房、遗传标记、等），特别需要使用乳房 CT 进行筛查。二期试验将进一步阐明这个问题。