Would Perioperative PET Imaging Improve Lumpectomy?

描述（由申请人提供）： 保乳手术的目标是通过完全切除肿瘤并切除最少的正常组织来进行局部控制。然而，在大约三分之一的乳房肿块切除术中，标本边缘含有癌细胞，强烈表明乳房中存在残留癌。这些残留细胞是局部复发的假定病因，并且通常用局部疗法（例如，再切除或放射）或全身治疗。术中超声已被用于减少乳腺肿块切除术边缘阳性的发生率。由于超声通常不能检测原位癌（40%的病例与肿瘤切除术切缘阳性相关），术中超声不太可能完全解决肿瘤切除术切缘阳性的问题。我们提出使用图像引导手术，其中使用新型高分辨率专用乳腺正电子发射断层扫描（“PET”）扫描仪在手术前确定癌症的位置和程度。已发表的试验数据表明，这种高性能扫描仪（2.5 mm全宽半高空间分辨率）可以准确地确定乳腺癌的大小。 一项前瞻性计划的对照临床试验，涉及264名妇女计划进行乳房肿瘤切除术谁被随机分为两组相同的大小。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PET扫描，根据需要放置导丝或标记物以指定癌症范围和位置。对病理学记录的随访审查将确定肿瘤切除术切缘阳性患者的比例。对照组受试者将不接受PET扫描，并将像试验组一样审查其记录。统计学考虑表明，当应用围手术期PET扫描的结果时，我们可能会观察（80%把握度）肿块切除术边缘的患者百分比是否降低2倍（即从30%降至15%）。配套的私人资金已经承诺用于该SBIR项目的所有阶段。

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.