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

描述(申请人提供)：保乳手术(BCS)通常被定义为切除具有安全边缘的正常组织的乳腺肿瘤的外科手术。当辅以放射治疗时，BCS通常被称为保乳治疗，或BCT。在接受BCS的患者中，乳腺癌的局部复发是一个严重增加的风险。例如，Atkins和他的同事已经证明，局部切除后的局部复发率为16%，而乳房切除后的局部复发率为8%，即使辅以放疗和化疗5。由于BCS的目标是不在乳房留下任何癌症，因此在实施BCS时获得肿瘤阴性切缘是将局部复发风险降至最低的护理标准。尽管试图获得负的切缘，但BCS的初次切除可获得20%至55%的组织学正切缘7。此外，确定切缘状态的黄金标准--永久切片组织病理学--通常要在患者离开手术室后才能获得。因此，很高比例的患者(初次切除切缘阳性的患者中有20%到55%)必须回到医院进行再次手术切除。术中切缘评估方法是为了在患者仍在手术台上时提供切缘状态的信息，到目前为止，这种方法的临床价值有限。这项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，从而减少与该手术相关的再次手术切除率。第一阶段的研究目标是：具体目标1：设计和开发一种最适合BCS的手术标本容器。具体目标2：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，真实地描述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：利用模拟切除的乳腺组织标本，对照已建立的BCS临床要求，对标本容器进行临床前评估。我们建议量化这一工具在以下方面的效果：标本的正交射线成像；提供最佳的标本压缩；以及从标本在手术室中切除到标本被送到病理科的时间，它保持标本的三维空间方位的能力。

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.