Intra-operative specimen tomosynthesis for margin assessment in breast surgery

描述(申请人提供)：这项研究的目标是开发第一个便携式的术中数字标本断层合成系统，用于在保乳手术(BCS)中对手术切除的乳腺组织标本进行快速和准确的三维放射边缘评估。当患者仍在手术室时，三维放射学边缘评估系统可以可靠地预测宏观切除边缘状态，可以降低手术再切除和与BCS相关的局部复发率。建议的体外断层合成系统也可以作为一个现实的试验台，用于评估断层合成在乳房组织三维成像中的临床效果，预计目前正在开发全乳房筛查断层合成系统。具体目标1：指定、设计和集成BCS中针对手术切除的乳腺组织标本优化的术中断层合成系统的硬件组件。具体目标2：指定、设计和实施优化的重建算法，用于手术切除的乳腺组织标本的术中快速和准确的断层合成。具体目标3：整合为手术切除的乳腺组织标本进行术中断层合成而优化的选定硬件和软件组件。具体目标4：利用模拟切除的乳腺组织样本和标准的乳腺X光成像模体，在临床前环境中量化集成系统的有效性。在这项研究的第一阶段，我们将利用计算机模拟和物理模型来量化设备和相关软件算法的有效性。在第二阶段，我们将进行一项正式的临床试验，以量化由于使用在第一阶段开发和优化的术中标本断层合成系统而导致的手术再次切除率的任何潜在降低。与公共卫生相关：研究表明，接受根治性乳腺癌切除治疗的乳腺癌妇女与接受肿块切除加放射治疗的乳腺癌妇女之间的存活率没有显著差异。然而，接受肿块切除和放射治疗的患者的再次手术切除率和局部乳腺癌复发率至少是乳房切除术患者的两倍。我们建议设计和建立一个三维放射学切除边缘评估系统，该系统可以帮助选择肿块切除而不是乳房切除的乳腺癌患者减少手术再切除和局部复发率。

DESCRIPTION (provided by applicant): This research proposal targets the development of the first portable intra-operative digital specimen tomosynthesis system for rapid and accurate three-dimensional radiographic margin assessment of surgically excised breast tissue specimens during breast-conserving surgery (BCS). A three-dimensional radiographic margin assessment system, which can reliably predict macroscopic excision margin status while the patient is still in the operating room, could reduce both surgical re-excision and local recurrence rates associated with BCS. The proposed ex-vivo tomosynthesis system could also serve as a realistic test bed for assessing the clinical efficacy of tomosynthesis in three dimensional imaging of breast tissue, in anticipation of full-breast screening tomosynthesis systems currently under development. Specific Aim 1: Specify, design and integrate hardware components of an intra- operative tomosynthesis system optimized for surgically excised breast tissue specimens in BCS. Specific Aim 2: Specify, design and implement reconstruction algorithms optimized for rapid and accurate intra-operative tomosynthesis of surgically excised breast tissue specimens. Specific Aim 3: Integrate selected hardware and software components optimized for intra-operative tomosynthesis of surgically excised breast tissue specimens. Specific Aim 4: Quantify the integrated system's efficacy in a pre-clinical setting, utilizing simulated excised breast tissue samples and standard breast x-ray imaging phantoms. In Phase I of this research, we will utilize both computer-simulated and physical phantoms to quantify the efficacy of the device and associated software algorithms. In phase II, we will conduct a formal clinical trial to quantify any potential reduction in surgical re-excision rates attributable to the use of the intra-operative specimen tomosynthesis system developed and optimized in Phase I. PUBLIC HEALTH RELEVANCE: Studies have shown no significant difference in survival rates between women with breast cancer who are treated with radical mastectomy versus those treated with lumpectomy in conjunction with radiation therapy. However, surgical re-excision rates and local breast cancer recurrence rates in patients treated with lumpectomy and radiation therapy are at least twice as high as those treated with mastectomy. We propose to design and build a three-dimensional radiographic excision margin assessment system which can help reduce both surgical re-excision and local recurrence rates in breast cancer patients who select lumpectomy over mastectomy.