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）：该研究提案针对的是开发首个便携式内部数字标本间压系统，以快速，准确的三维放射线照相缘评估在乳腺癌手术期间手术切除的乳腺组织标本（BC）（BC）（BC）。一个三维的放射线范围评估系统，可以可靠地预测宏观切除边距状态，而患者仍在手术室中，可以降低外科手术重新分离和与BCS相关的局部复发率。提出的前体型间歇合成系统还可以作为现实的测试床，用于评估乳腺组织三维成像中延型合成的临床功效，预计目前正在开发的全胸筛查层状合成系统。特定目标1：指定，设计和集成了针对BC中手术切除的乳腺组织样品优化的手术内整合系统的硬件组件。具体目标2：指定，设计和实施精制的重建算法，以快速，准确的手术性术中术中切除的乳房组织样品的术中术中。特定目标3：整合了针对手术切除的乳腺组织样品的术中性合成的选定硬件和软件组件。特定目标4：使用模拟切开的乳腺组织样品和标准的乳房X射线成像幻影，量化综合系统在临床前的设置中的功效。在这项研究的第一阶段，我们将利用计算机模拟和物理幻象来量化设备和相关软件算法的功效。在第二阶段中，我们将进行一项正式的临床试验，以量化归因于使用术内样品内的Tomosynthesis系统的任何潜在降低。然而，接受乳房切除术和放射治疗治疗的患者的手术重新分离率和局部乳腺癌复发率的高度至少是接受乳房切除术治疗的乳腺癌的两倍。我们建议在乳腺癌患者中选择乳腺癌患者而不是乳腺切除术而不是乳腺癌的患者，以设计和建立三维的放射线切除边缘评估系统。