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）：根据先前的资金，我们设计并建造了四个乳腺CT扫描仪。最新的扫描仪被称为“ Doheny”，利用了一个新的检测器系统，该系统可提供高空间分辨率和低噪声乳房CT图像。该提案的目标包括乳腺CT的软件优化和临床试验比较，以筛查正常风险女性以及高风险女性。软件优化：该项目的前两个目标涉及（1）软件的开发，这些软件既可以纠正与X射线散射相关的拔罐工件，又可以恢复乳腺CT图像的定量完整性，使它们具有出色的灰度精度。在Doheny系统上已经实施了基于硬件的散点测量程序（“反向光束停止”）；该特定目标将根据反向光束停止数据提供的信息来优化软件校正。 （2）由于新可用的组件，Doheny扫描仪的空间分辨率是我们早期系统的4倍。在此目标中，我们将优化重建内核和矩阵尺寸，以确保相对于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：将招募数百名将作为标准护理的一部分进行乳房活检的女性（Birads 4和5），以在活检之前进行额外的影像，包括（研究前后）两种乳房的乳腺CT乳房CT成像，以及（标准，FDA批准）对比（标准，FDA批准）对比增强了乳房MRI（特定的AIM AIM AIM 3）。在AIM 4中，使用接收器操作特征（ROC）方法，仅针对乳房X线摄影以及乳房X线摄影 +乳清合成，将比较非对比度增强乳腺CT的潜力。在特定的AIM 5中，将使用ROC方法与护理标准对比度增强的MRI（包括非对比度和对比度图像）进行比较的乳腺CT图像（包括对比前和对比后图像）。本研究提出的临床试验结果应提供有力的证据，以乳腺癌的潜力在正常风险和高风险人群中进行乳腺癌筛查的潜力。