STEREOTACTIC BREAST BIOPSY VS OPEN-SURGICAL BIOPSY

本研究的目的是确定1） 立体定向细针活检（SFNA）和立体定向粗针活检 （SCNB）结果与手术结果和2）适当使用 乳腺X线引导立体定向细针抽吸， 立体定向空芯针活检在乳腺癌诊断中的应用 乳腺病变不明显的女性。一项随机临床试验将 通过全国12个乳房X光检查中心的联盟进行， 每个基金在资助期内提供100-400个案例。的广度 乳房X光检查在这些群体中很有代表性。这提供 有机会涵盖经验，设备和患者的范围 人口，使用商定的协议来评估SFNA的使用， SCNB。 在所有研究中心，妇女都进行了适当的乳房X线检查评估， 符合研究入选标准的受试者将被随机分配至 SFNA/SCNB组或试验的SCNB组。SFNA/ SCNB组 将先进行SFNA，然后进行SCNB，然后继续进行开放性活检，或 随访SCNB中的患者将接受SCNB，然后进行开放性手术 活检或随访。在SFNA部门，放射科医生也将 测试使用和不使用同轴针的取样技术 替代患者的位置。所有病理学和细胞学标本 将送交独立专家进行第二次解释， 乳房X线照片将有第二个独立的读数， 病变将制定一个决策和成本效益模型， 分析了数据分析将包括使用 Kappa统计和逻辑回归，以及 癌症的准确性使用逻辑回归分析。此外，分析 观察者的变异性、样本率不足和预测能力 将进行特定乳房X光检查。

The objectives of this research are to determine 1) the agreement of stereotactic fine needle biopsy (SFNA) and stereotactic core needle biopsy (SCNB) results with surgical results and 2) the appropriate use of mammographically guided stereotactic fine needle aspiration and stereotactic core needle biopsy, in the diagnosis of breast cancer in women with nonpalpable breast lesions. A randomized clinical trial will be carried out through a consortium of 12 mammography centers nationwide, each contributing 100-400 cases over the grant period. The breadth of mammography practice is well represented among these groups. This offers the opportunity to cover the spectrum of experience, equipment and patient populations, using an agreed upon protocol to evaluate the use of SFNA and SCNB. At all sites, women having had the appropriate mammographic evaluation, and meeting the study entry criteria will be randomized either to the SFNA/SCNB arm or the SCNB arm of the trial. Those in the SFNA/ SCNB arm will have an SFNA followed by a SCNB, then will go on to open biopsy or follow-up. Those in the SCNB will have the SCNB followed by open surgical biopsy or follow-up. Within the SFNA arm, radiologists will also be testing the sampling techniques with and without use of coaxial needle placement on alternate patients. All pathologic and cytologic specimens will be sent to independent experts for a second interpretation, and all mammograms will have second independent readings for characterization of lesions. A decision and cost effectiveness model will be developed and analyzed. Data analysis will consist of estimating agreement, using a kappa statistic, and logistic regression, and estimation of detection of cancer accuracy using a logistic regression analysis. In addition analysis of observer variability, insufficient sample rates, and predictive ability of specific mammographic characteristics will be conducted.