Breast CT: Final Steps to Translation

乳房 CT：翻译的最后步骤

• 批准号: 8830613
• 负责人: JOHN M BOONE
• 金额: $ 59.96万
• 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/8830613
• 关键词: Affect; Applications Grants; Biomedical Research; Biopsy; Breast; Breast Cancer Detection; Breast Microcalcification; Breast biopsy; Caring; 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; 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; public health relevance; 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，我们设计并建造了四台乳腺 CT 扫描仪。最新的扫描仪被称为“Doheny”，采用新的探测器系统，可提供高空间分辨率和低噪声的乳腺 CT 图像。该提案的目标包括用于筛查正常风险女性和高风险女性的乳腺 CT 的软件优化和临床试验比较。软件优化：该项目的前 2 个目标涉及 (1) 开发软件，既可以校正与 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。基于硬件的散射测量程序（“反向光束停止”）已在 Doheny 系统上实施；该具体目标将侧重于根据反向光束光阑数据提供的信息优化软件校正。 (2) 由于采用了新的组件，Doheny 扫描仪的空间分辨率是我们早期系统的 4 倍。为此，我们将优化重建内核和矩阵维度，以确保微钙化检测的最佳性能，这需要非常高的空间分辨率。临床评估：将招募 400 名将进行乳腺活检作为标准护理（BIRADS 4 和 5）一部分的女性，在活检前接受额外的成像，包括（研究）双侧乳房对比增强前和对比增强后乳腺 CT 成像，以及（标准、FDA 批准）对比增强乳腺 MRI（具体目标 3）。在目标 4 中，将使用接受者操作特征 (ROC) 方法与单独的乳房 X 光检查以及乳房 X 光检查 + 断层合成技术对非造影增强乳腺 CT 的潜力进行比较。在具体目标 5 中，将使用 ROC 方法将乳腺 CT 图像（包括对比前和对比后图像）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。本次调查中提出的临床试验结果应为乳腺 CT 在正常风险和高风险人群中筛查乳腺癌的潜力提供强有力的证据。