Improving diagnostic US for reduction of benign breast biopsies using US-guided Optical Tomography

使用超声引导光学断层扫描改进超声诊断以减少良性乳腺活检

• 批准号: 10059187
• 负责人: Steven Poplack
• 金额: $ 39.39万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-12-13 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10059187
• 关键词: Algorithms; Allergic Reaction; Appearance; Automatic Data Processing; Benign; Biopsy; Blood Vessels; Breast; Breast Diseases; Breast biopsy; Cancer Detection; Castes; Categories; Characteristics; Clinic; Clinical; Clinical Trials; Complement; Data; Decision Making; Diagnosis; Diagnostic; Disease; Emerging Technologies; Excision; Goals; Growth; Health Care Costs; Hemoglobin; Hemoglobin concentration result; Histologic; Histopathologic Grade; Imaging Techniques; Information Systems; Lesion; Low Dose Radiation; Malignant - descriptor; Malignant Neoplasms; Mammary Ultrasonography; Mammography; Maps; Measures; Metabolic; Monitor; Nuclear Grade; Operative Surgical Procedures; Optical Tomography; Optics; Pathologic; Patient Care; Patients; Physicians; Predictive Value; Process; Radiology Specialty; Renal function; Reporting; Risk; Role; S-Phase Fraction; Sensitivity and Specificity; Specificity; Statistical Data Interpretation; Statistical Methods; System; Techniques; Technology; Time; Tissues; Tumor Angiogenesis; Ultrasonography; United States; Universities; Validation; Washington; accurate diagnosis; angiogenesis; base; breast cancer diagnosis; breast imaging; breast lesion; cancer diagnosis; clinical practice; cohort; contrast enhanced; detection sensitivity; diffuse optical tomography; image guided; image reconstruction; improved; malignant breast neoplasm; novel; patient subsets; prospective; radiologist; real-time images; reconstruction; recruit; screening; treatment response; tumor

Title: Improving diagnostic US specificity on breast biopsies using US-guided Diffuse Optical Tomography Abstract In current clinical practice, while the characteristics of malignant and benign breast lesions are well established by conventional imaging techniques, the overlapping appearances of malignant and benign lesions have prompted radiologists to recommend biopsy for most low and moderate risk breast lesions. As a result, in the United States, approximately one million image-guided breast biopsies are performed each year, with the majority of the lesions yielding benign results. Many attempts to improve this situation have not been successful. This application will explore the potential impact of Ultrasound (US)-guided diffuse optical tomography (DOT) as an adjunct to US in a diagnostic setting, with the goal of reducing benign biopsies without compromising cancer detection sensitivity. US-guided DOT provides hemoglobin concentration values and distributions which in turn map out lesion vascularity or angiogenesis. Recently, we retrospectively evaluated 288 patients to assess the potential clinical impact of our technique in characterizing low and moderate risk breast lesions, which might not need to be biopsied if the US-guided DOT technology were used in the biopsy decision making process. In this patient cohort, the total hemoglobin level combined with two radiologists’ diagnosis achieved high sensitivity of 96.6-100% on cancer detection and negative predictive value of 99-100%. Using a conservative threshold for the total hemoglobin (tHb) data to differentiate lesions based on the amount of vascularity, we found the number of lesions that would be referred to biopsy decreased by approximately 45% on average, while maintaining high detection sensitivity. Our hypotheses are: 1) The first hypothesis is that the measured tHb values and distribution can be potentially used as an adjunct for radiologists to reduce unnecessary biopsies in low risk patients with benign pathological results; and 2) The second hypothesis is that while reducing unnecessary benign biopsies, the addition of adjunct information from US-guided DOT still maintains a high sensitivity of capturing nearly all malignant tumors. In this application, we propose three aims: 1) Optimization and validation of a new non-iterative imaging reconstruction algorithm and new statistical methods for automated data processing, robust data selection, with the goal of near real-time imaging for onsite diagnosis by physicians. This is a significant step forward to bring this technology into clinics; 2) To prospectively assess the impact of adjunctive US-guided DOT to conventional breast imaging on accurate breast cancer diagnosis and reduction of benign biopsy. Approximate 300 patients will be recruited at the Radiology Department of Washington University to validate the early retrospective results; and 3) Perform statistical analysis to validate the reduction of benign biopsy while maintaining high sensitivity. The successful completion of the project will help initiate a paradigm shift in how we manage low risk benign lesions without compromising cancer detection sensitivity in current clinical practice and will reduce health care cost without compromising patient care.

标题：使用超声引导的漫射光学提高乳腺活检的超声诊断特异性 断层扫描 抽象的 在目前的临床实践中，虽然恶性和良性乳腺病变的特征已明确 通过传统的成像技术，恶性和良性病变的重叠表现 因此，放射科医生建议对大多数低风险和中风险的乳腺病变进行活检。 美国每年进行大约一百万次图像引导乳腺活检，其中 大多数病变产生良性结果，许多改善这种情况的尝试都没有成功。 此应用程序将探讨超声 (US) 引导的漫射光学断层扫描 (DOT) 的潜在影响： 诊断环境中超声的辅助手段，目的是在不影响癌症的情况下减少良性活检 US 引导的 DOT 提供血红蛋白浓度值和分布。 最近，我们回顾性评估了 288 名患者，以评估病变血管分布或血管生成。 我们的技术在描述低风险和中风险乳腺病变方面的潜在临床影响，这可能不会 如果在活检决策过程中使用美国引导的 DOT 技术，则需要进行活检。 在患者队列中，总血红蛋白水平结合两名放射科医生的诊断达到了高灵敏度 癌症检测率为 96.6-100%，阴性预测值为 99-100%。 总血红蛋白 (tHb) 数据根据血管数量区分病变，我们发现了 需要进行活检的病变平均减少约 45%，同时保持较高水平 检测灵敏度。 我们的假设是： 1）第一个假设是测量的 tHb 值和分布可能是潜在的 用作放射科医生的辅助手段，以减少对良性病理低危患者进行不必要的活检 结果；2）第二个假设是，在减少不必要的良性活检的同时，添加辅助手段 美国引导的DOT信息仍然保持捕获几乎所有恶性肿瘤的高灵敏度。 对于这个应用，我们提出了三个目标：1）优化和验证新的非迭代成像 重建算法和新的统计方法，用于自动数据处理、稳健的数据选择， 医生现场诊断的近实时成像目标是向前迈出的重要一步。 2) 前瞻性评估美国引导的辅助 DOT 对传统技术的影响 乳房成像可准确诊断乳腺癌并减少约 300 名患者的良性活检。 将在华盛顿大学放射科招募来验证早期回顾性结果； 3) 进行统计分析，以验证良性活检的减少，同时保持高灵敏度。 该项目的成功完成将有助于我们管理低风险良性的方式发生范式转变 在当前临床实践中，在不影响癌症检测灵敏度的情况下检测病变，并将减少医疗保健 成本而不影响患者护理。