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 “不可触及的乳腺病变特征”该计划是一项合作计划 由十个机构组成的联盟响应 RFA:CA 93-01 的努力。 我们的提案涉及科学研究和协调 本 RFA 的临床联盟组成部分。该团体包括 来自以下领域的经验丰富的研究人员和临床专家 机构：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，纪念斯隆凯特林，埃默里，放射学 影像联营公司、女执事医院和凯斯西储大学。 该计划的总体目标是制定临床决策 不可触及乳腺病变的评估和诊断矩阵 这通常适用于广泛的机构。 该算法将源自优化的输入标准，增强 诊断准确性，减少噪音（变化）并产生有利的结果 健康结果、成本效益比和成本效益。 该提案的具体目标是：（1）比较准确性和 立体定向细针抽吸细胞学 (SFNAC) 的功效和 立体定向空心针活检 (SCNB) 联合乳腺外科活检 (SBB) 用于诊断和治疗不可触及（亚临床）乳腺病变。 这些指标将针对两个应用程序进行测试： 具有低至中等恶性概率的“不确定”病变 作为后续乳房 X 光检查的替代方案，以及 b) 乳腺诊断 癌症和手术乳腺活检的潜在替代。 (2) 识别 病灶选择的最佳标准化方法、立体定向 成像、立体定向针取样以及细胞学和组织学 诊断。 (3) 评估患者相关因素的影响，例如 乳腺癌的风险、对立体定向的态度和看法 乳腺针吸活检 (SBNB) 与 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由此产生的成本 使用 SBNB 代替 SBB 来评估不可触及的乳房，可节省成本 病变。 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协议。