Would Perioperative PET Imaging Improve Lumpectomy?

围手术期 PET 成像会改善肿瘤切除术吗？

• 批准号: 6953039
• 负责人: JUDITH E KALINYAK
• 金额: $ 38.01万
• 依托单位: NAVISCAN PET SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6953039
• 关键词: autoradiography; bioimaging /biomedical imaging; biomedical equipment development; biopsy; breast neoplasm /cancer diagnosis; breast surgery; clinical research; clinical trial phase I; cytodiagnosis; female; human subject; image guided surgery /therapy; image processing; mammography; neoplasm /cancer radionuclide diagnosis; patient oriented research; positron emission tomography; prognosis; radionuclide imaging /scanning; radiotracer; sectioning

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.

描述（由申请人提供）： 乳房保存手术的目的是通过最小的正常组织切除术完全清除肿瘤来控制局部控制。然而，在大约三分之一的乳房切除术中，标本缘含有癌细胞，强烈表明乳腺中存在残留癌。这些残留细胞是局部复发的假定病因，通常通过局部治疗（例如，重新测试或放射线）或全身治疗进行治疗。术中超声已用于降低肿块阳性切除术的发生率。由于超声通常不会检测到原位癌（在40％的病例中与肿块肿块切除术边缘相关），因此术中超声不太可能完全解决肿块切除术阳性的问题。我们建议使用图像引导的手术，其中一种新型的高分辨率专用乳房正电子发射断层扫描（“ PET”）扫描仪用于定义手术前癌症的位置和程度。已发布的试点数据表明，这种高性能扫描仪（2.5毫米全宽度的半最大空间分辨率）可以准确地定义乳腺癌的大小。 提出了一项前瞻性计划的对照临床试验，涉及264名计划进行乳房切除术的妇女，这些妇女被随机分为两组相等的妇女。在测试组中，受试者将在手术前对受影响的乳房进行高分辨率PET扫描，并根据需要放置导线或标记物以指定癌症的程度和位置。病理记录的后续审查将确定肿块阳性切除术阳性的患者的比例。对照组的成员将不会接受PET扫描，并将像测试小组一样对记录进行审查。统计考虑因素表明，当应用围手术期PET扫描结果时，我们可能会观察到（具有80％功率）是否会降低2倍（即从30％到15％）。该SBIR项目的所有阶段已经投入匹配的私人资金。