Breast CT: Final Steps to Translation

乳房 CT：翻译的最后步骤

• 批准号: 9054809
• 负责人: JOHN M BOONE
• 金额: $ 57.57万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-15 至 2020-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9054809
• 关键词: Affect; Applications Grants; Biomedical Research; Biopsy; Breast; Breast Cancer Detection; Breast Microcalcification; Breast biopsy; Clinical Trials; Communities; Computer software; Critiques; Data; Data Set; Detection; Digital Mammography; Dimensions; Disease; FDA approved; Frequencies; Funding; Goals; Grant; Gray unit of radiation dose; Health; High Risk Woman; Human; Image; Inferior; Injection of therapeutic agent; Investigation; Laboratories; Lesion; Location; Low Dose Radiation; Magnetic Resonance Imaging; Malignant Neoplasms; Mammography; Measurement; Methodology; Methods; Modality; Morphologic artifacts; Noise; Patient risk; Patients; Performance; Physics; Population; Predictive Value; Probability; Procedures; Reader; Receiver Operating Characteristics; Recruitment Activity; Reporting; Research; Resolution; Risk; Site; System; Techniques; Time; Translations; Ultrasonography; United States National Institutes of Health; Woman; X-Ray Computed Tomography; base; breast imaging; cohort; contrast enhanced; contrast imaging; design; detector; high risk; image processing; image reconstruction; imaging modality; improved; malignant breast neoplasm; mortality; power analysis; radiologist; reconstruction; research clinical testing; screening; software development; standard care; standard of care; tomography

DESCRIPTION (provided by applicant): Under previous funding, we have designed and built four breast CT scanners. The latest scanner, dubbed "Doheny", makes use of a new detector system which delivers high spatial resolution and low noise breast CT images. The objectives of this proposal include software optimization and clinical trial comparisons of breast CT for screening normal risk women as well as high risk women. Software optimization: The first 2 aims of this project involve (1) the development of software which both corrects for the cupping artifacts associated with x-ray scatter, and restores the quantitative integrity of the breast CT images such that they have excellent gray-scale accuracy. A hardware-based scatter measurement procedure ("reverse beam stop") has been implemented on the Doheny system; this Specific Aim will focus on optimizing the software corrections based upon the information provided by the reverse beam stop data. (2) Due to newly available components, the Doheny scanner has 4 times the spatial resolution of our earlier systems. In this aim, we will optimize th reconstruction kernel and matrix dimensions to assure maximal performance with respect to microcalcification detection, which requires very high spatial resolution. Clinical evaluation: Fou hundred women who will be having breast biopsy as part of their standard care (BIRADS 4 and 5) will be recruited to undergo additional imaging prior to biopsy, including (research) pre-and post- contrast enhanced breast CT imaging of both breasts, as well as (standard, FDA approved) contrast enhanced breast MRI (Specific Aim 3). In Aim 4, the potential of non-contrast enhanced breast CT will be compared using receiver operating characteristic (ROC) methodology against mammography alone, as well as with mammography + tomosynthesis. In Specific Aim 5, the breast CT images (including both pre-and post-contrast images) will be compared using ROC methodology against standard-of-care contrast-enhanced MRI (which includes both non-contrast and contrast images). The results of the clinical trials proposed in this investigation should provide strong evidence in regards to the potential of breast CT for breast cancer screening in the normal risk and high risk populations.

描述（由申请人提供）：在之前的资助下，我们设计并制造了四台乳腺CT扫描仪。最新的扫描仪，被称为“Doheny”，利用一种新的探测器系统，提供高空间分辨率和低噪音的乳房CT图像。本提案的目的包括软件优化和乳腺CT筛查正常风险女性和高风险女性的临床试验比较。软件优化：本项目的前两个目标涉及(1)软件的开发，该软件既可以纠正与x射线散射相关的拔罐伪影，又可以恢复乳腺CT图像的定量完整性，使其具有出色的灰度精度。在Doheny系统上实现了基于硬件的散射测量程序（“反向波束停止”）；本特定目标将侧重于基于反向波束停止数据提供的信息优化软件校正。(2)由于采用了新组件，Doheny扫描仪的空间分辨率是我们早期系统的4倍。在这个目标中，我们将优化重建核和矩阵维度，以确保在微钙化检测方面的最大性能，这需要非常高的空间分辨率。临床评估：400名将进行乳房活检作为其标准护理（BIRADS 4和5）的女性将被招募，在活检之前接受额外的成像，包括（研究）双侧乳房的造影前和造影后CT成像，以及（标准的，FDA批准的）造影增强乳房MRI （Specific Aim 3）。在Aim 4中，将使用受试者工作特征（ROC）方法与单独的乳房x光检查以及乳房x光检查+断层合成检查比较非对比增强乳房CT的潜力。在具体目标5中，将使用ROC方法将乳房CT图像（包括前后对比图像）与标准护理对比增强MRI（包括非对比图像和对比图像）进行比较。本研究提出的临床试验结果应该为乳腺CT在正常风险人群和高危人群中筛查乳腺癌的潜力提供强有力的证据。