Intra-operative specimen tomosynthesis for margin assessment in breast surgery

术中标本断层合成用于乳腺手术切缘评估

• 批准号: 7667559
• 负责人: Emre Toker
• 金额: $ 9.99万
• 依托单位: SURGICAL TOOLS, LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-06 至 2010-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7667559
• 关键词: 3-Dimensional; Address; Algorithms; Award; Axillary lymph node group; Beds; Breast; Breast-Conserving Surgery; Cancer Patient; Chest; Clinical; Clinical Trials; Clip; Computer software; Computers; Development; Devices; Diagnostic radiologic examination; Dimensions; Disease; Dose; Evolution; Excision; Gold; Grant; Histologic; Histopathology; Hospitals; Image; Imaging Phantoms; Institution; Left; Malignant Neoplasms; Mammary Gland Parenchyma; Mammary Neoplasms; Mammography; Mastectomy; Mechanics; Metals; Microscopic; Monitor; Morphologic artifacts; Motion; Muscle; Noise; Normal tissue morphology; Operating Rooms; Operative Surgical Procedures; Pathology; Patients; Performance; Phase; Physicians; Power Sources; Principal Investigator; Publishing; Radiation therapy; Radical Mastectomy; Radiology Specialty; Recurrence; Research; Research Proposals; Residual Tumors; Residual state; Resolution; Risk; Rotation; Screening procedure; Sensitivity and Specificity; Signal Transduction; Simulate; Slice; Source; Specific qualifier value; Specimen; Staging; Survival Rate; System; Systems Integration; Techniques; Terminology; Testing; Time; Tissue Sample; Tissues; Tube; Woman; Work; X-Ray Computed Tomography; breast lumpectomy; breast surgery; cancer recurrence; clinical efficacy; design; detector; digital; improved; malignant breast neoplasm; novel; pre-clinical; public health relevance; reconstruction; standard of care; tool; tumor; two-dimensional; voltage

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.

描述（由申请人提供）：本研究提案旨在开发第一个便携式术中数字标本断层合成系统，用于在保乳手术（BCS）期间对手术切除的乳腺组织标本进行快速准确的三维放射学边缘评估。三维影像学边缘评估系统，可以可靠地预测宏观切除边缘状态，而病人仍然在手术室，可以减少手术再切除和局部复发率与BCS。所提出的离体断层合成系统也可以作为一个现实的测试床，用于评估乳腺组织三维成像中断层合成的临床疗效，预计目前正在开发的全乳房筛查断层合成系统。具体目标1：指定、设计和集成针对BCS中手术切除的乳腺组织样本优化的术中断层合成系统的硬件组件。具体目标二：指定、设计和实施重建算法，优化用于快速准确地对手术切除的乳腺组织标本进行术中断层合成。具体目标3：集成选定的硬件和软件组件，针对手术切除的乳腺组织标本的术中断层合成进行优化。具体目标4：利用模拟切除的乳腺组织样本和标准乳腺X射线成像体模，在临床前环境中量化集成系统的功效。在本研究的第一阶段，我们将利用计算机模拟和物理幻影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切除率的任何潜在降低。公共卫生相关性：研究表明，接受根治性乳房切除术治疗的乳腺癌妇女与接受肿块切除术联合放射治疗的乳腺癌妇女之间的生存率没有显著差异。然而，接受乳房肿瘤切除术和放射治疗的患者的手术再切除率和局部乳腺癌复发率至少是接受乳房切除术的患者的两倍。我们建议设计和建立一个三维放射学切除边缘评估系统，可以帮助减少手术再切除和局部复发率的乳腺癌患者选择乳房肿瘤切除术。