STEREOTACTIC BREAST BIOPSY VS OPEN-SURGICAL BIOPSY

这项研究的目标是确定1)协议 立体定向细针活检(SFNA)和立体定向芯针活检 (SCNB)结果与手术结果以及2)适当使用 乳房摄影引导下立体定向细针抽吸术 立体定向核心针活检在乳腺癌诊断中的应用 患有不可触及乳房病变的女性。一项随机临床试验将是 通过一个由全国12个乳房X光检查中心组成的财团进行， 每个人在资助期内贡献100-400个案例。广度，广度 乳房X光摄影实践在这些群体中得到了很好的代表。这提供了 有机会涵盖各种经验、设备和患者 人口，使用商定的议定书来评估SFNA的使用和 SCNB。 在所有地点，妇女都进行了适当的乳房X光检查， 符合研究进入标准的将被随机分配到 SFNA/SCNB臂或试验的SCNB臂。SFNA/SCNB分支中的那些 将先进行SFNA，然后进行SCNB，然后继续打开活组织检查或 后续行动。那些在SCNB中的人将接受SCNB，然后是开放手术 活组织检查或随访。在SFNA的分支中，放射科医生也将 测试使用和不使用同轴针的取样技术 安置在候补病人身上。所有病理和细胞学标本 将被送往独立专家进行第二次解释，所有 乳房X光检查将有第二次独立读数来表征 损伤。将开发决策和成本效益模型，并 分析过了。数据分析将包括估计协议，使用 Kappa统计量、Logistic回归和检测的估计 使用Logistic回归分析的癌症准确率。此外，分析 观察者的可变性、采样率不足和预测能力 将进行特定的乳房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.