Breast CT: Final Steps to Translation

乳房 CT：翻译的最后步骤

• 批准号: 9266769
• 负责人: JOHN M BOONE
• 金额: $ 55.66万
• 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/9266769
• 关键词: Affect; Applications Grants; Awareness; 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; High Risk Woman; Human; Image; Inferior; Injection of therapeutic agent; Investigation; Laboratories; Lesion; Location; Low Dose Radiation; Magnetic Resonance Imaging; Malignant Neoplasms; Mammography; Mathematics; Measurement; Methodology; Methods; Modality; Morphologic artifacts; Noise; Patient risk; Patients; Performance; Physics; Predictive Value; Probability; Procedures; Reader; Receiver Operating Characteristics; Recruitment Activity; Reporting; Research; Resolution; Risk; Roentgen Rays; Site; System; Techniques; Time; Translations; Ultrasonography; United States National Institutes of Health; Woman; X-Ray Computed Tomography; X-Ray Tomography; base; breast imaging; cohort; contrast enhanced; contrast imaging; design; detector; high risk; high risk population; image processing; image reconstruction; imaging modality; improved; malignant breast neoplasm; mortality; power analysis; public health relevance; radiologist; reconstruction; research clinical testing; screening; software development; standard care; standard of care; study characteristics; tomography; tomosynthesis

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.

简介(申请人提供)：在前期资金的支持下，我们已经设计并制造了四台乳腺CT扫描仪。最新的扫描仪被称为“Doheny”，它利用了一种新的探测器系统，可以提供高空间分辨率和低噪声的乳腺CT图像。该提案的目标包括对乳腺CT筛查正常风险妇女和高危妇女的软件优化和临床试验比较。软件优化：本项目的前两个目标包括：(1)开发软件，既纠正与X射线散射相关的拔罐伪影，又恢复乳腺CT图像的定量完整性，使其具有出色的灰度准确性。已经在Doheny系统上实施了基于硬件的散射测量程序(“反向光束停止”)；这一具体目标将侧重于根据反向光束停止数据所提供的信息来优化软件校正。(2)由于新的可用组件，Doheny扫描仪的空间分辨率是我们早期系统的4倍。在这一目标中，我们将优化重建核和矩阵维度，以确保微钙化检测的最大性能，这需要非常高的空间分辨率。临床评估：400名将接受乳腺活检作为其标准护理的一部分(BIRADS 4和5)的妇女将被招募在活检前接受额外的成像，包括(研究)双侧乳房的增强前后的CT成像，以及(标准的，FDA批准的)对比增强的乳腺MRI(特定目标3)。在目标4中，将使用接收器操作特征(ROC)方法将非对比增强乳腺CT的潜力与单独的乳房X光检查以及与乳房X光检查+断层合成进行比较。在具体目标5中，将使用ROC方法将乳腺CT图像(包括增强前后图像)与标准护理对比增强MRI图像(包括非对比图像和对比图像)进行比较。这项研究中提出的临床试验结果应该为乳腺癌CT在正常风险和高危人群中进行乳腺癌筛查的潜力提供强有力的证据。