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）：乳腺癌是一种疾病美国和其他地方的发病率以及战斗的人口水平的方法该疾病主要是针对筛查的，早期使用乳房X线摄影检测。使用乳房X线摄影发现的乳腺癌的中位数为约11毫米。基于涉及计算机的广泛初步研究模拟，物理测量和尸体乳房成像，我们发现乳房CT可能会常规地检测到较小的乳腺肿瘤， 3至5毫米范围。重要的是，乳房CT的辐射剂量在在详细的研究中发现80 kVP与乳房X线摄影相当。不可能使用临床上的现场女性单独对乳房进行图像 CT扫描仪。因此，在这项生物工程研究合作伙伴建议中，我们已经与来自全国各地的科学家合作设计，构建和测试 CT扫描仪，旨在成像乳房。由医疗组成的团队物理学家，医师，机械和电气工程师以及乳腺癌倡导者将在乳房CT扫描仪的设计上进行合作。锥束平板技术将用于生产能够10秒的扫描仪乳房扫描，扫描仪开发也将包括乳房固定系统（丙烯酸缸），乳房CT桌子，快速重建计算机和计算机工作站定制为高效查看乳房CT图像。扫描仪将在加州大学戴维斯（UC Davis）在3年的时间内涉及9个特定目标。乳房后 CT扫描仪在简短的I期试验中进行了测试（2个特定目的），将是搬到乳房成像诊所进行II期试验，其中约有120次妇女将被成像（4个特定目标）。该第二阶段试验将评估乳腺CT在一组乳腺癌早期检测的功效妇女可能患有乳腺癌（Birads 4和5）。另外，乳房将研究图像数据的实用性，以自动化分析正常的乳房结构，用于计算机癌检测。在第五年拟议的研究，两个具体的目的利用乳房CT数据和相应的乳房X线摄影图像（在-240乳房上）以评估理想观察者表现和人类（乳房X线摄影师）检测性能属性乳房CT扫描仪。在涉及17的拟议研究结束时具体目的，乳腺CT的潜力将被评估定性和定量。经过测试的高质量原型乳房CT 扫描仪将准备入伍参加III期试验（超出了这项拟议的研究），如果有必要进一步测试。性能数据在本研究中获得的将允许A的适当设计（功率等）第三阶段试验。如果乳房CT持有其巨大的潜力最初的成像，在转移发生之前，乳腺癌将是可以检测到的 - 例如，3毫米肿瘤仅包含11个细胞计数的2％ MM病变和5 mM病变仅包含细胞计数的9％。基于在100天的卷增加时间，检测5 mm病变将导致 0.93年前检测和常规检测3毫米病变将导致在1.5年前的乳房X线摄影检测中。早期手术去除癌症将有效地治愈大多数筛查的女性使用此技术。乳房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（乳房密集，遗传标记，等等）特别保证使用乳房CT进行筛查。 II期试验将为这个问题提供更多启示。