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 关于当前乳腺癌检测和诊断的主要关注点是大量良性 进行活检。每年在美国，放射科医生回想起超过500万妇女 诊断检查和执行超过一百万个乳房活检，不到四分之一的诊断性 癌症。 4A/b/c的新的BI-RADS 4子集评估类别可实现新的量身定制方法 在不同案件的不同子集中基于“风险”的决策。在此分类方案中，评级为4A的病变具有 预期的恶性肿瘤概率超过2％和多达10％，而被评为4B的可能性 恶性肿瘤超过10％，最高50％。最近评估积极预测价值的出版物（PPV3） 在美国放射学院（ACR）国家乳房X线摄影学院收集的125,447次诊断检查 数据库（NMD）表明，在BI-RADS 4A和4B病变上进行了88％的活检。那， 存在机会，可以更准确地确定更好地对这些低概率病变进行分类的新方法 为了改善PPV3并减少每年数十万名妇女实际良性发现的活检。 我们认为，执行的操作简单，成本效益，对比增强了乳房X线照片（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 需要进行活检病变的决定，以乳房X线摄影，横向合成（DBT）或美国为4A或4B。 CEM使用碘对比度与双低和高KEV乳房X线照片图像创建对比度增强 直接覆盖乳房X线照片的乳房图，从而提供解剖和动力学信息， 类似于MRI。我们在一项初步临床试验中发现，放射科的真实阳性率较高，较低 与使用DBT和我们相比，使用CEM进行活检建议的假阳性率。验证这些 最初的发现，我们建议对1855年同意妇女双重妇女进行前瞻性和顺序执行CEM RADS 4A或4B病变在乳房X线摄影，DBT或US上检测到。预期的放射科医生将提供双期 单独使用DBT，然后与我们一起使用CEM的每个病变的RAD评级。随着病理已知和 基于研究设计以最大程度地减少放射科医生的潜在偏见，我们计划估计NPV水平 基于CEM的建议（总体而言，在常规确认活检的情况下 建议）并证明它足够高，同时导致活检大量降低 实际良性病变的建议。我们的主要期望是建议数量 活检良性病变将显着降低（约20％），同时保持高NPV（> 95％） 最初的建议。使用前瞻性收集的经过验证的案件的子集，我们将进行多个 读者（MRMC）研究评估放射科医生CEM效应的异质性，获得了可普遍的结果， 并通过病变特征阐明补充特定的CEM性能。