Intra-operative radiographic margin assessment tool for breast-conserving surgery

描述（由申请人提供）：保乳手术（BCS）通常定义为手术切除乳腺肿瘤，并保留正常组织的安全边缘。当辅以放射治疗时，BCS通常被称为保乳治疗或BCT。乳腺癌局部复发是接受BCS患者的严重风险增加。例如，阿特金斯及其同事已经表明，局部切除术后的局部复发率为16%，而乳房切除术后的局部复发率为8%，即使辅以放疗和化疗5。由于BCS的目的是不留下任何癌症在乳房中，获得肿瘤阴性边缘时，进行BCS是护理标准，以尽量减少局部复发的风险6。尽管尝试获得阴性切缘，但BCS的原发性切除产生组织学阳性切缘的概率为20%至55%。此外，永久切片组织病理学，确定边缘状态的金标准，通常在患者离开手术室后很久才可用。因此，很高比例的患者（20 - 55%的患者在初次切除时切缘阳性）必须返回医院进行再次手术切除。术中切缘评估方法旨在提供患者仍在手术台上时的切缘状态信息，迄今为止临床价值有限。本研究的长期目标是提高BCS期间切除的乳腺组织标本的术中边缘评估技术的敏感性和特异性，从而降低与该手术相关的手术再切除率。I期研究目标是：具体目标1：设计和开发针对BCS优化的手术标本容器。具体目标二：开发嵌入模拟微钙化、结节和纤维的模拟切除乳腺组织标本，真实地描绘实际临床乳腺组织标本的物理和X射线成像特征。具体目标3：根据BCS的既定临床要求，使用模拟切除的乳腺组织样本对样本容器进行临床前评价。我们建议量化该工具在以下方面的功效：标本的正交X射线成像;提供标本的最佳压缩;以及其从标本在手术室中被切除到标本被递送到病理科的时间保持标本的三维空间取向的能力。

DESCRIPTION (provided by applicant): Breast-conserving surgery (BCS) is commonly defined as the surgical removal of a breast tumor with a safe margin of normal tissue. When supplemented with radiation therapy, BCS is generally referred to as breast-conserving therapy, or BCT. Local recurrence of breast cancer is a serious increased risk in patients undergoing BCS. For example, Atkins and colleagues have shown that the local recurrence rate following local excision was 16%, compared with 8% following mastectomy, even when supplemented with radiotherapy and chemotherapy5. Since the objective of BCS is not to leave any cancer behind in the breast, obtaining tumor-negative margins when performing BCS is the standard of care to minimize the risk of local recurrence6. Despite the attempt to achieve negative margins, primary excision for BCS yields histologically positive margins 20% to 55% of the time7. Furthermore, permanent section histopathology, the gold standard of determining margin status, is generally not available until well after the patient has left the operating room. As a result, a high percentage of patients (20 to 55% of patients with positive margins in primary excision) must return to the hospital for surgical re-excisions. Intra-operative methods of margin assessment, which are designed to provide information on margin status while the patient is still on the operating table, have so far been of limited clinical value. The long-term objective of this research is to improve the sensitivity and specificity of intra-operative margin assessment techniques for breast tissue specimens excised during BCS, and thus reduce surgical re-excision rates associated with this procedure. Phase I study objectives are: Specific Aim 1: Design and develop a surgical specimen container optimized for BCS. Specific Aim 2: Develop simulated excised breast tissue specimens with embedded simulated microcalcifications, nodules and fibers, which realistically depict both the physical and x-ray imaging characteristics of actual clinical breast tissue specimens. Specific Aim 3: Perform the pre-clinical evaluation of the specimen container against established clinical requirements of BCS utilizing simulated excised breast tissue specimens. We propose to quantify the efficacy of this tool with respect to: orthogonal x-ray imaging of specimens; providing optimal compression of specimens; and its ability to retain the three dimensional spatial orientation of the specimen from the time the specimen is excised in the operating room to the time the specimen is delivered to the Pathology Department.