STAGING BREAST CANCER WITH POSITRON EMISSION TOMOGRAPHY

描述(改编自申请人的摘要)：调查人员 建议进行一项多中心前瞻性试验，以评估 正电子发射断层扫描(PET)示踪剂2-(18-F)- 氟-2-脱氧-D-葡萄糖(FDG)对初诊患者的分期价值 乳腺癌。他们的研究还将确定预后价值。 从初始正电子发射计算机断层扫描中获得的信息作为 无病生存。三个临床站点将贡献患者 研究：密歇根大学医学中心(Ann Arbor， 密歇根大学)、华盛顿大学医学中心(密苏里州圣路易斯)和杜克大学 大学医学中心(达勒姆，北卡罗来纳州)。数据管理将是 由美国放射学会临床试验分部提供。 研究设计以及中期和最终数据分析将由以下人员协调 哈佛大学医学院的首席研究员和研究人员 学校。他们提出的进行这项研究的机制 在其他几项前瞻性评估中成功使用的Parallels 癌症的成像方法。以下科学评估将 进行：(1)正电子发射计算机断层扫描(PET)检测腋窝的准确性 将确定乳腺癌的淋巴结转移情况。疾病状况 将通过腋下结节解剖和仔细的组织学来证实 腋窝淋巴结切除后的检查。这将是 通过研究三个表演中的每一个的138名女性完成的 超过30个月的采购期。患者总数 在数据采集阶段将在三个中心之间进行研究 将是414。(2)信息的预后价值 初始PET分期作为无病生存期的指标 否则将确定复发。这将在一个 患者预提完成后的随访观察期。在这 后续阶段，将在以下位置获得骨扫描(386个/绩效站点) 每年一次的间隔以及仔细的体检和例行检查 血液化学研究。他们将确定PET分期是否会导致 乳腺癌提供类似或更高水平的预后 预测无病生存期的信息比标准信息 侵入性分期方法。通过这次多中心试验，他们预计 要有足够的患者收益来定义(1)FDG PET的准确性 在乳腺癌淋巴结转移分期中的作用和(2)能力 FDG-PET对患者当时复发风险的分层 最初的演示文稿。这些数据对于确定 正电子发射计算机断层扫描在初诊患者诊断算法中的作用 在确定单次非侵袭性PET是否为乳腺癌方面 研究可以取代腋窝清扫在此类患者的分期中的作用。 FDG对结节状态和预后的无创性评估 PET将代表着超越肿块切除术的下一个重要步骤 最大限度地减少患者的毁容，允许越来越多的非侵入性 乳腺癌的治疗。

DESCRIPTION (Adapted from applicant's abstract): The investigators propose a multicenter prospective trial to assess the accuracy of Positron Emission Tomography (PET) performed with the tracer 2-(18-F)- fluoro-2-deoxy-D-glucose (FDG) in staging patients with newly diagnosed breast carcinoma. Their study will also determine the prognostic value of information derived from the initial PET scans as an indicator of disease-free survival. Three clinical sites will contribute patients to the study: the University of Michigan Medical Center (Ann Arbor, MI); Washington University Medical Center (St. Louis, MO); and Duke University Medical Center (Durham, NC). Data management will be provided by the American College of Radiology Clinical Trials Division. Study design and interim and final data analyses will be coordinated by the principal investigator and investigators from the Harvard Medical School. The mechanism they propose for conduct of this study closely parallels that used successfully in several other prospective evaluations of imaging methods in cancer. The following scientific assessments will be performed: (1) The accuracy of PET for the detection of axillary nodal metastasis of breast cancer will be determined. Disease status will be proven by axillary nodal dissection with careful histological examination of the removed axillary lymph nodes. This will be accomplished by studying 138 women at each of the three performance sites over a 30-month acquisition period. The total number of patients to be studied among the three centers during the data-acquisition phase will be 414. (2) The prognostic value of information derived from the initial PET staging procedure as an indicator of disease-free survival or recurrence will be determined. This will be achieved during a follow-up observation period after patient accrual is completed. In this follow-up phase, bone scans (386/performance site) will be obtained at yearly intervals as well as careful physical examinations and routine blood chemistry studies. They will ascertain whether PET staging of breast cancer offers a similar or greater level of prognostic information for predicting disease-free survival than do standard invasive staging methods. Through this multicenter trial, they expect to have sufficient patient accrual to define (1) the accuracy of FDG PET in staging nodal metastases of breast carcinoma and (2) the capability of FDG PET for stratifying patient risk of recurrent disease at the time of initial presentation. Such data are essential for determining the role of PET in the diagnostic algorithm of patients with newly diagnosed primary breast cancer and in determining whether a single noninvasive PET study can replace axillary dissection in the staging of such patients. Successful noninvasive assessment of nodal status and prognosis by FDG PET would represent the next important step beyond lumpectomy in minimizing patient disfigurement, allowing for increasingly noninvasive therapy of breast cancer.