Breast CT scanner for earlier cancer detection

描述（由申请人提供）：这是一份关于乳房CT生物工程研究合作伙伴关系（BRP）的竞争性更新申请。在过去的4.3年里，我们开发了两种乳房CT扫描仪，并且是第一个在患者中展示锥束乳房CT性能的小组，截至2007年1月，有94名患者成像。我们还开发了在垂坠乳房CT几何中进行准确剂量评估的方法，并明确表明，在与双视图乳房x线摄影相同的辐射水平下可以产生高质量的乳房CT图像。上一个资助期的目标取得了良好的成果，有12名学员、14篇同行评议论文、11篇其他论文、2章、15篇摘要和21篇受邀演讲。在本提案中，我们寻求通过进一步的技术发展结合临床评估来显著扩展基础乳腺CT平台的临床应用。将设计和制造一种新的乳房CT扫描仪，利用现有扫描仪的基本框架，但结合滑环，脉冲x射线和螺旋采集；该系统将允许对正常手术进行厚扇束螺旋扫描，对注射造影剂的研究进行锥形束乳房成像。除了开发新的诊断成像模式，包括对比动力学曲线评估、断层合成、乳房PET/CT和放大模式乳房CT，还提出了理论和数值分析方法，如理想观察者评估和计算机辅助诊断方法，以更好地了解乳房断层扫描的基本诊断潜力。我们建议在bCT平台上进一步发展硬件，使其成为多功能的乳腺癌分析和治疗工具，允许微创图像引导乳腺癌治疗方案，包括机器人引导乳腺活检，射频消融和x线消融。该研究计划描述了四个发展阶段的16个目标(1)新硬件开发，(2)改进解释和诊断的分析工具，(3)图像引导乳腺癌评估和治疗的技术开发，以及(4)乳腺CT诊断和治疗的临床试验。两台几乎完全相同的乳房CT扫描仪将分别安装在加州大学戴维斯分校和加州大学圣地亚哥分校，两个地点的患者累积数据将使800多名患者能够进行研究，并进行许多交叉比较。非侵入性成像将在II期临床试验中进行，而微创研究将在较小的I期试验中进行。在这个研究和发现项目结束时，乳房CT可能会被证明是诊断和治疗乳腺癌的关键临床工具。

DESCRIPTION (provided by applicant): This is a competitive renewal application for a bioengineering research partnership (BRP) on breast CT. Over the past 4.3 years, we have developed two breast CT scanners and were the first group to demonstrate the performance of cone beam breast CT in patients, with 94 patients imaged as of January 2007. We also developed the methodology for accurate dose assessment in the pendant breast CT geometry, and have unambiguously shown that excellent quality breast CT images can be produced at radiation levels equal to two view mammography. Good productivity has been achieved in the aims of the previous funding period, with 12 trainees, 14 peer reviewed papers, 11 other papers, 2 chapters, 15 abstracts and 21 invited presentations. In this proposal, we seek to significantly extend the clinical utility of the basic breast CT platform through further technical development combined with clinical evaluation. A new breast CT scanner will be designed and fabricated, utilizing the basic framework of an existing scanner but incorporating a slip ring, pulsed x-rays, and helical acquisition; the system will allow thick fan beam helical scanning for normal operation and cone beam breast imaging for studies using contrast agent injection. In addition to developing new diagnostic imaging modes including contrast kinetic curve assessment, tomosynthesis, breast PET/CT and magnification-mode breast CT, theoretical and numerical analysis methods such as ideal observer assessment and computer aided diagnosis methods are proposed to better understand the fundamental diagnostic potential of breast tomography. We propose further hardware development on the bCT platform so that it will serve as a multifunctional breast cancer analysis and treatment tool, allowing minimally invasive image guided treatment regimes for breast cancer, including robotically guided breast biopsy, radiofrequency ablation, and x-ray ablation. The research plan describes 16 aims in four phases of development (1) new hardware development, (2) analytical tools for improving interpretation and diagnosis, (3) technology development for image guided assessment and treatment of breast cancer, and (4) clinical trials in breast CT diagnosis and treatment. Two nearly identical breast CT scanners will be fabricated and sited at UC Davis and UC San Diego, and patient accrual at two sites will enable the study of over 800 patients, with many cross comparisons. Non-invasive imaging will proceed in Phase II clinical trials, while the minimally invasive studies will be performed in smaller Phase I trials. At the end of this program of research and discovery, breast CT will likely be shown to be a key clinical tool for the diagnosis and treatment of breast cancer.