Would Perioperative PET Imaging Improve Lumpectomy?

描述(由申请人提供)： 保乳手术的目标是通过切除最小的正常组织来完全切除肿瘤来控制局部。然而，在大约三分之一的肿块切除术中，标本边缘含有癌细胞，这强烈表明乳腺中存在残余癌症。这些残留细胞被认为是局部复发的原因，通常采用局部治疗(例如，再次切除或放射治疗)或全身治疗。术中超声已被用来减少肿瘤切缘阳性的发生率。由于超声通常不能发现原位癌(40%的病例与肿瘤切缘阳性相关)，术中超声不太可能完全解决肿瘤切缘阳性的问题。我们建议使用图像引导手术，在手术前使用一种新型的高分辨率专用乳腺正电子发射断层扫描(“PET”)扫描仪来确定癌症的位置和范围。已公布的试点数据表明，这种高性能扫描仪(2.5 mm全宽半最大空间分辨率)可以准确地确定乳腺癌的大小。 提出了一项前瞻性计划的对照临床试验，涉及264名计划接受肿块切除术的妇女，她们被随机分为两组，每组大小相等。在试验组中，受试者将在手术前对受影响的乳房进行高分辨率的PET扫描，并根据需要放置导丝或标记，以确定癌症的范围和位置。对病理记录的后续回顾将确定肿瘤切除切缘阳性患者的比例。受试者的控制组成员将不会接受正电子发射计算机断层扫描，他们的记录将像试验组一样得到审查。统计学方面的考虑表明，当应用围手术期PET扫描的结果时，我们可能会观察(80%的力量)肿瘤切除切缘的患者百分比是否减少了两倍(即从30%到15%)。已经承诺为该SBIR项目的所有阶段提供相应的私人资金。

DESCRIPTION (provided by applicant): The goal of breast conservation surgery is local control through complete tumor removal with minimal normal tissue excision. However, in about one-third of lumpectomies, specimen margins contain cancer cells, strongly suggesting the presence of residual cancer in the breast. These residual cells are the presumed etiology of local recurrence, and are typically treated with local therapy (e.g., re-excision or radiation) or systemic therapy. Intraoperative ultrasound has been used to reduce the incidence of positive lumpectomy margins. Since ultrasound does not typically detect in situ cancer (which is associated with positive lumpectomy margins in 40% of cases), intraoperative ultrasound is not likely to completely solve the problem of positive lumpectomy margins. We propose the use of image-guided surgery in which a novel high resolution dedicated breast positron emission tomography ("PET") scanner is used to define the location and extent of cancer prior to surgery. Published pilot data suggest that this high performance scanner (2.5 mm full-width half-maximum spatial resolution) can accurately define the size of breast cancers. A prospectively planned controlled clinical trial is proposed, involving 264 women scheduled for lumpectomy who are randomized into two groups of equal size. In the test group, subjects will have high resolution PET scans of the affected breast prior to surgery, with guide wires or markers placed as needed to specify the cancer extent and location. Follow-up reviews of pathology records will determine the fraction of patients with positive lumpectomy margins. Members of the control group of subjects will not receive PET scans, and will have their records reviewed as in the test group. Statistical considerations suggest that we are likely to observe (with 80% power) whether the percentage of patients with lumpectomy margins decreases by a factor of two (i.e. from 30% to 15%) when the results from perioperative PET scans are applied. Matching private funds are already committed for all phases of this SBIR project.