STAGING BREAST CANCER WITH POSITRON EMISSION TOMOGRAPHY

描述（改编自申请人摘要）：研究者 建议进行一项多中心前瞻性试验， 使用示踪剂2-（18-F）- 氟-2-脱氧-D-葡萄糖（FDG）在新诊断的 乳腺癌他们的研究还将确定 从最初的PET扫描中获得的信息， 无病生存率三个临床研究中心将提供患者 密歇根大学医学中心（安阿伯， MI）、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，NC）。数据管理部门将 由美国放射学会临床试验部提供。 研究设计以及中期和最终数据分析将由 首席研究员和来自哈佛医学中心的研究人员 学校他们提出的进行这项研究的机制与 在其他几个前瞻性评价中成功使用的相似之处 癌症的成像方法。以下科学评估将 （1）PET检测腋窝淋巴结的准确性 将确定乳腺癌的淋巴结转移。疾病状态 将通过仔细的组织学腋窝淋巴结解剖来证实 检查切除的腋窝淋巴结。这将是 通过对三场演出中的138名女性进行研究， 在30个月的收购期内。患者总数 三个中心在数据收集阶段进行研究 将是414。(2)从这些数据中获得的信息的预后价值 作为无病生存指标的初始PET分期程序 或者将确定复发。这将在一个 患者招募完成后的随访观察期。在这 随访阶段，将在以下时间点进行骨扫描（386/性能部位）： 每年的间隔以及仔细的身体检查和例行检查 血液化学研究他们将确定是否PET分期的 乳腺癌提供了类似或更高水平的预后 预测无病生存率的信息 侵入性分期方法。通过这项多中心试验，他们预计 有足够的患者累积来定义（1）FDG PET的准确性 在乳腺癌淋巴结转移的分期和（2）能力 FDG PET用于分层患者当时疾病复发的风险 最初的介绍。这些数据对于确定 PET在新诊断患者诊断算法中的作用 原发性乳腺癌和确定是否一个单一的非侵入性PET 研究可以取代腋窝淋巴结清扫术在这类患者的分期。 FDG对淋巴结状态和预后的成功无创评估 PET将代表肿瘤切除术之后的下一个重要步骤， 最大限度地减少患者的毁容， 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.