Contrast Enhanced Mammography (CEM) to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study

对比增强乳房X光检查（CEM）可降低高度可疑乳房异常的活检率：一项前瞻性研究

• 批准号: 10540765
• 负责人: Margarita L Zuley
• 金额: $ 46.63万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-14 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10540765
• 关键词: Adopted; American College of Radiology; Anatomy; Anxiety; Appearance; Architecture; Area; Benign; Biopsy; Breast; Breast Cancer Detection; Breast biopsy; Cancer Detection; Case Study; Categories; Characteristics; Classification; Classification Scheme; Clinical; Clinical Trials; Consent; Coupled; Databases; Detection; Diagnosis; Diagnostic; Evaluation; Frequencies; Heterogeneity; Image; Institutional Review Boards; Iodine; Kinetics; Lesion; Magnetic Resonance Imaging; Malignant Neoplasms; Mammography; Maps; Outcome; Pathology; Patients; Performance; Perfusion; Pilot Projects; Predictive Value; Probability; Procedures; Prospective Studies; Protocols documentation; Publications; ROC Curve; Reader; Recommendation; Research Design; Risk; Sampling; Schedule; Sensitivity and Specificity; Site; Stress; Testing; Time; Tumor Biology; Uncertainty; United States; Update; Woman; anatomic imaging; breast lesion; calcification; cancer diagnosis; case-based; contrast enhanced; cost effective; expectation; improved; indexing; novel; personalized approach; preservation; prospective; radiologist; response; screening; soft tissue; standard of care; tomosynthesis; trend; ultrasound

Abstract A primary concern regarding current breast cancer detection and diagnosis is the large number of benign biopsies being performed. Annually in the United States, radiologists recall over five million women for diagnostic workup and perform over one million breast biopsies, with fewer than one in four diagnosed as cancer. The new BI-RADS 4 subset assessment categories of 4A/B/C enables new tailored approaches for “risk” based decisions in different subsets of cases. In this classification scheme, lesions rated as 4A have an expected probability of malignancy more than 2% and up to 10% and those rated as 4B have a probability of malignancy more than 10% and up to 50%. A recent publication evaluating the positive predictive value (PPV3) for 125,447 diagnostic exams collected in the American College of Radiology (ACR) National Mammography Database (NMD) demonstrated that 88% of biopsies were performed on BI-RADS 4A and 4B lesions. Thus, opportunity exists to identify novel ways to better classify these low probability lesions more accurately in order to improve PPV3 and reduce biopsy of actually benign findings for hundreds of thousands of women annually. We believe that an operationally simple, cost effective, contrast enhanced mammogram (CEM), performed during the patient's diagnostic evaluation, would be the best approach to improve accuracy of radiologists' decisions for need to biopsy lesions classified with mammography, tomosynthesis (DBT) or US as 4A or 4B. CEM uses iodine contrast with dual low and high KeV mammogram images to create a contrast enhancement map of the breast that directly overlays the mammogram, thus providing anatomic and kinetic information, similar to MRI. We found in a preliminary clinical trial that radiologists had higher true-positive rates and lower false-positive rates for biopsy recommendation with CEM than when using DBT and US. To validate those initial findings, we propose to prospectively and sequentially perform CEM on 1855 consenting women with BI- RADS 4A or 4B lesions detected on mammography, DBT or US. Prospectively radiologists will provide BI- RADS ratings for every lesion using DBT alone, then with US and finally with CEM. With pathology known and based on the study design to minimize case by radiologist potential biases, we plan to estimate the NPV level of CEM-based recommendations (overall and within the cases with conventionally confirmed biopsy recommendation) and demonstrate that it is sufficiently high, while leading to substantial reduction in biopsy recommendations for actually benign lesions. Our primary expectation is that the number of recommendations to biopsy benign lesions will decrease significantly (~20%), while maintaining high NPV (>95%) among the initial recommendations. Using a subset of prospectively collected verified cases we will conduct a multi- reader (MRMC) study to assess heterogeneity of CEM effects across radiologists, obtain generalizable results, and elucidate supplemental specific CEM performance by lesion characteristics.

抽象的 当前乳腺癌检测和诊断的一个主要问题是大量良性肿瘤 在美国，放射科医生每年都会对超过 500 万名女性进行活检。 诊断检查并进行超过一百万次乳房活检，其中不到四分之一被诊断为 新的 BI-RADS 4 子集评估类别 4A/B/C 为癌症提供了新的定制方法。 在不同的病例子集中基于“风险”的决策在此分类方案中，评级为 4A 的病变具有 4A 级。 预期恶性概率超过 2% 且高达 10%，且评级为 4B 的患者的概率为 最近的一篇出版物评估了阳性预测值 (PPV3)。 美国放射学会 (ACR) 国家乳房 X 光检查收集的 125,447 份诊断检查 数据库 (NMD) 表明 88% 的活检是在 BI-RADS 4A 和 4B 病变上进行的。 存在机会找到新的方法来更好地对这些低概率病变进行更准确的分类，以便 每年为数十万女性改善 PPV3 并减少实际良性结果的活检。 我们相信，操作简单、成本效益高、对比增强的乳房 X 光检查 (CEM) 在患者的诊断评估期间，将是提高放射科医生准确性的最佳方法 决定是否需要对病变进行活检，并通过乳房 X 线摄影、断层合成 (DBT) 或 US 分类为 4A 或 4B。 CEM 使用碘对比度与低 KeV 和高 KeV 乳房 X 光图像来增强对比度 直接覆盖乳房 X 光照片的乳房图，从而提供解剖和动力学信息， 与 MRI 类似，我们在初步临床试验中发现，放射科医生的真阳性率较高，而较低。 使用 CEM 进行活检建议的假阳性率高于使用 DBT 和 US 时的假阳性率。 初步发现，我们建议对 1855 名同意的 BI-女性进行前瞻性、连续的 CEM 治疗。 RADS 4A 或 4B 在乳房 X 光检查、DBT 或 US 上检测到病变，未来放射科医生将提供 BI-。 单独使用 DBT 对每个病变进行 RADS 评级，然后使用 US，最后使用 CEM 进行已知病理学评估。 根据旨在尽量减少放射科医生潜在偏差的研究设计，我们计划估计 NPV 水平 基于 CEM 的建议（总体以及在常规活检证实的病例中） 建议）并证明它足够高，同时导致活检数量大幅减少 我们的主要期望是建议的数量。 活检良性病变将显着减少 (~20%)，同时保持较高的 NPV (>95%) 我们将使用前瞻性收集的经过验证的案例子集进行初步建议。 读者 (MRMC) 研究评估放射科医生 CEM 效应的异质性，获得可推广的结果， 并通过病变特征阐明补充的特定 CEM 性能。