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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(申请人提供)：乳腺癌是一种高风险的疾病。美国和其他地方的发病率，以及人口层面的战斗方法本病主要用于筛查，早期使用乳房X光检查侦测。使用乳房X光摄影发现的乳腺癌的中位数是大约11毫米。基于涉及计算机的广泛的初步研究模拟、物理测量和身体乳房成像，我们发现乳腺CT也许能够常规地检测出更小的乳腺肿瘤，在 3到5毫米的范围。重要的是，乳腺CT的辐射剂量在在详细的研究中发现80kVp与乳房X光摄影的结果相当。在活体妇女身上单独成像乳房是不可能的，使用临床 CT扫描仪。因此，在这项生物工程研究伙伴关系提案中，我们已经与来自全国各地的科学家合作设计、建造和测试用来对乳房进行成像的CT扫描仪。由医疗队组成的团队物理学家、内科医生、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。锥形梁平板技术将被用于生产一种能够10秒的扫描仪乳房扫描，而扫描仪的开发还将包括乳房固定系统(亚克力圆柱体)，乳房CT床，FAST 重建计算机和为高效定制的计算机工作站查看乳腺CT图像。扫描仪将在以下位置进行构建、测试和优化加州大学戴维斯分校为期3年，涉及9个具体目标。乳房过后 CT扫描仪在简短的第一阶段试验中进行测试(2个具体目标)，它将转到乳房成像诊所进行II期试验，大约有120人女性将被成像(4个具体目标)。这项第二阶段试验将评估乳腺CT在早期发现乳腺癌中的作用可能患有乳腺癌的妇女(BIRADS 4和5)。此外，乳房我们将研究图像数据在自动分析正常的乳房结构，以及计算机化的癌症检测。年第5年拟议的研究有两个具体目标，利用乳房CT数据和相应的乳房X光检查图像(对-240个乳房)进行评估观察者性能和人类(乳房X光摄影者)检测性能属性乳房CT扫描仪。在拟议的研究结束时，涉及17 特定的目标，乳腺CT的潜力将被评估为定性的和定量的。经过测试的高质量乳腺CT原型扫描仪将准备好进入第三阶段试验(超出这项拟议的研究)，如果进一步的测试是必要的。性能数据在本研究中获得的将允许适当的设计(电源等)一种第三阶段试验。如果乳腺CT发挥其巨大的潜力，基于最初的成像，乳腺癌在转移发生之前就可以被检测到 -例如，一个3 mm的肿瘤只包含11个肿瘤的2%的细胞 5 mm的病变仅含9%的细胞计数。基座在100天的体积倍增时间内，检测到5 mm的病变将导致 0.93年前检测，并常规检测3 mm病变在1.5年前检测到的乳房X光检查。早期手术切除癌症将有效地治愈大多数接受筛查的妇女使用这项技术。而乳腺CT可能会提高癌症的检测能力在所有女性中，一些女性可能有风险因素(丰满的乳房，遗传标记，等)尤其需要使用乳房CT进行筛查。第二阶段试验将在这个问题上提供更多的线索。