RDOG V--STEREOTACTIC BX FOR NONPALPABLE BREAST LESIONS

RDOG V--立体定向 BX 用于不可触及的乳房病变

• 批准号: 2008433
• 负责人: JENNIFER A HARVEY
• 金额: $ 5.63万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-30 至 1999-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2008433
• 关键词: biomedical automation; biopsy; breast neoplasm /cancer diagnosis; breast surgery; charge coupled device camera; clinical trials; computer assisted diagnosis; cooperative study; cytodiagnosis; diagnosis design /evaluation; diagnosis quality /standard; fine needle aspiration; health care cost /financing; histopathology; human morbidity; human subject; neoplasm /cancer classification /staging; neoplasm /cancer radiodiagnosis; phantom model; questionnaires; stereotaxic techniques

"Radiologic Diagnostic Oncology Group V: Stereotactic Biopsy for Nonpalpable Breast Lesion Characterization" This plan is a cooperative effort from a consortium of ten institutions in response to RFA:CA 93-01. Our proposal addresses the scientific research and coordination of the clinical consortium component of this RFA. The group comprises experienced investigators and clinical experts from the following institutions: University of Arizona, Johns Hopkins, Yale, UCLA, University of Virginia, Memorial Sloan-Kettering, Emory, Radiology Imaging Associates, Deaconess Hospital, and Case Western University. The overall objective of this plan is to develop a clinical decision matrix for the evaluation and diagnosis of nonpalpable breast lesions that would be generally applicable to a broad spectrum of institutions. The algorithm will be derived from optimized input criteria that enhance diagnostic accuracy, reduce noise (variation) and result in favorable health outcomes, cost-benefit ratio and cost effectiveness. The Specific Aims of this proposal are: (1) Compare the accuracy and efficacy of stereotactic fine needle aspiration cytology (SFNAC) and stereotactic core needle biopsy (SCNB) with surgical breast biopsy (SBB) for diagnosis and management of nonpalpable (subclinical) breast lesions. These metrics will be tested for two applications: a) management of "indeterminant" lesions with low to moderate probability of malignancy as an alternative to follow-up mammography, and b) diagnosis of breast cancer and potential replacement of surgical breast biopsy. (2) Identify optimal, standardized approaches to lesion selection, stereotactic imaging, stereotactic needle sampling and cytologic and histologic diagnosis. (3) Evaluate the impact of patient-related factors such as risk for breast cancer, attitudes and perceptions regarding stereotactic breast needle biopsy (SBNB) versus SBB, and morbidity for the three diagnostic modalities (SFNAC, SCNA & SBB) on the proposed decision matrix. (4) Assess the health outcomes and potential resultant costs savings of using SBNB in lieu of SBB to evaluate nonpalpable breast lesions. Formulate data accumulated from this trail into guidelines for clinical practice and protocols for health policy issues.

放射诊断肿瘤学第五组：立体定向活检 不可触及的乳房病变特征“这项计划是一个合作 由十个机构组成的联合体为响应RFA所做的努力：CA 93-01。 我们的建议涉及科学研究和协调 此RFA的临床联盟组件。该小组包括 来自以下机构的经验丰富的研究人员和临床专家 院校：亚利桑那大学、约翰·霍普金斯大学、耶鲁大学、加州大学洛杉矶分校、 弗吉尼亚大学，纪念斯隆-凯特琳，埃默里，放射学 影像助理、女执事医院和凯斯西大学。 该计划的总体目标是制定一项临床决策 评价和诊断不可触及的乳腺病变的矩阵 这将普遍适用于范围广泛的机构。 该算法将从优化的输入标准派生而来，该标准增强了 诊断准确，减少噪音(变化)，并取得良好的结果 健康结果、成本效益比和成本效益。 这项建议的具体目的是：(1)比较准确性和 立体定向细针吸取细胞学检查的疗效 立体定向核心针活检(SCNB)与外科乳腺活检(SBB) 用于诊断和处理不可触及的(亚临床)乳房病变。 这些指标将针对两个应用程序进行测试：a)管理 低度至中度恶性的“不确定”病变 作为后续乳房X光检查的替代方案，以及b)乳房诊断 癌症和潜在的乳房活检手术替代。(2)识别 最佳、标准化的病变选择方法，立体定向 影像、立体定向针头取样、细胞学和组织学 诊断。(3)评估患者相关因素的影响，如 乳腺癌的风险、对立体定向的态度和看法 乳房穿刺术(SBNB)与乳房穿刺术(SBB)比较，以及三者的发病率 关于拟议决定的诊断模式(SFNAC、SCNA和SBB) 矩阵。(4)评估健康结果和潜在的成本 用SBNB代替SBB评估未触及的乳房的成本 损伤。将从这次试验中积累的数据制定为指导方针 卫生政策问题的临床实践和方案。