Breast CT scanner for earlier cancer detection

用于早期癌症检测的乳房 CT 扫描仪

• 批准号: 6789982
• 负责人: JOHN M BOONE
• 金额: $ 99.64万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6789982
• 关键词: X ray; bioengineering /biomedical engineering; biomedical equipment development; biomedical equipment safety; breast neoplasm /cancer diagnosis; clinical research; clinical trial phase I; computed axial tomography; computer assisted diagnosis; computer simulation; computer system design /evaluation; diagnosis design /evaluation; diagnosis quality /standard; early diagnosis; female; human subject; image enhancement; mathematics; patient oriented research; radiation dosage; women' s health

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）：乳腺癌是一种高风险的疾病， 美国和其他地方的发病率，以及人口水平的战斗方法 这种疾病的主要目的是筛查，使用乳房X光检查， 侦测使用乳房X光检查发现的乳腺癌的中值大小是 基于广泛的初步研究，涉及计算机 模拟，物理测量和尸体乳房成像，我们发现 乳腺CT可能能够常规检测更小的乳腺肿瘤， 3至5 mm范围。重要的是，在以下条件下进行的乳腺CT的辐射剂量 在详细研究中发现，80 kVp与乳腺X线摄影相当。 不可能使用临床成像仪对活体女性的乳房单独成像。 CT扫描仪。因此，在这项生物工程研究伙伴关系提案中，我们 与来自全国各地的科学家合作， 一种用来给乳房成像的CT扫描仪一个由医疗人员组成的小组 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，扫描仪的发展也将包括乳房 固定系统（丙烯酸圆柱体），乳房CT床，快速 重建计算机，以及为高效重建而定制的计算机工作站。 查看乳房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在为期3年，涉及9个具体目标。乳房后 CT扫描仪在一个简短的I期试验（2个特定目标）中进行测试， 转移到乳房成像诊所进行第二阶段试验， 将对妇女进行宣传（4个具体目标）。该II期试验将评估 乳腺CT对早期发现乳腺癌的有效性 可能患有乳腺癌的女性（BIRADS 4和5）。此外，乳房 将研究图像数据在自动化分析中的效用， 正常的乳房结构，并用于计算机化的癌症检测。在第五年， 所提出的研究，两个具体目标利用乳房CT数据， 相应的乳房X线摄影图像（约240个乳房），以评估理想的 观察者性能和人类（乳房摄影师）检测性能属性 乳房CT扫描仪的图像在研究结束时，涉及17 具体目标，乳腺CT的潜力将得到评估， 定性和定量。经过测试的高质量原型乳腺CT 扫描仪将准备在第三阶段试验中服役（超出了 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（功率等）的 第三阶段试验。如果乳腺CT发挥其巨大的潜力， 在最初的成像中，乳腺癌在转移发生之前就可以被检测到。 - 例如，一个3毫米的肿瘤只含有11毫米肿瘤细胞数的2%， 5mm的病变仅包含9%的细胞计数。基于 在100天的体积倍增时间内，检测到5 mm病变将导致 0.93一年前检测，常规检测3 mm病变将导致 在1.5年前检测超过乳房X光检查。手术切除早期 癌症将有效地治愈大多数接受筛查的妇女， 使用这种技术。虽然乳房CT可能会提高癌症检测 在所有女性中，一些女性可能有风险因素（致密乳房，遗传标记， 等等）。特别值得使用乳腺CT进行筛查。II期试验 会对这个问题有更好的解释