Next-Generation Tomosynthesis Pilot Study

下一代断层合成试点研究

• 批准号: 10685548
• 负责人: Raymond Joseph Acciavatti
• 金额: $ 36.43万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-17 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10685548
• 关键词: 3-Dimensional; Abbreviations; Adipose tissue; Anisotropy; Anterior; Anxiety; Benign; Biopsy; Breast; Breast Cancer Detection; Callback; Cancerous; Caring; Cephalic; Chest wall structure; Clinical; Clinical Data; Clinical Trials; Cone; Data; Dedications; Diagnosis; Diagnostic Imaging; Digital Breast Tomosynthesis; Electromagnetic Energy; Entropy; Generations; Grant; Health Care Costs; High Risk Woman; Human; Image; Image Analysis; Imaging technology; Laplacian; Laws; Left; Localized Lesion; Magnetic Resonance Imaging; Malignant - descriptor; Malignant Neoplasms; Mammographic screening; Mastectomy; Measures; Medical; Memory; Methods; Modeling; Morphologic artifacts; Motion; Noise; Participant; Performance; Pilot Projects; Probability; ROC Curve; Radiation Dose Unit; Radiation exposure; Randomized; Reader; Reading; Receiver Operating Characteristics; Research; Resolution; Scanning; Schedule; Shapes; Side; Signal Transduction; Specificity; Specimen; Stress; Structure; System; Systems Development; Texture; Three-dimensional analysis; Time; Tissues; Translations; Woman; X-Ray Computed Tomography; breast density; breast imaging; calcification; density; design; experience; follow-up; human subject; improved; infancy; next generation; radiologist; reconstruction; recruit; response; screening; tomosynthesis; trend; tumor; ultra high resolution; volunteer

PROJECT SUMMARY Even with the latest digital breast tomosynthesis (DBT) systems, breast cancer screening continues to suffer from poor specificity. Only about 5% of women called-back from screening are ultimately found to have a biopsy- proven cancer. Clinical DBT systems suffer from anisotropies in image quality since the scanning motion is restricted to one direction (left-to-right). We built a next-generation tomosynthesis (NGT) system that is capable of scanning in the shape of a “T”. With phantoms and mastectomy specimens, we have shown that this design mitigates cone-beam artifacts, tissue superposition effects, and anisotropies in super-resolution. As the next step in our research, we will perform a pilot study with volunteers, recruiting women referred for diagnostic imaging or biopsy as well as women having abbreviated magnetic resonance imaging (MRI). Projection images will be acquired in such a way that we can generate reconstructions from two scanning methods (conventional and T). Each scanning method will be analyzed separately by radiologists in different reading sessions. We will mitigate potential concerns about radiation exposure by restricting the study to one view (cranial-caudal) instead of two views. We have put together a team with a unique set of strengths, including the developers of the NGT system, three radiologists, two statisticians, and experts in density and texture analysis. This proposal is divided into two specific aims. (Aim 1): Assess radiologists' performance in a pilot study of the NGT system with volunteers. We will investigate whether the T scan brings down the call-back rate of screening without reducing sensitivity. Radiologists will also rate the overall probability of malignancy, and these scores will be analyzed in combination with clinical follow-up data to show that radiologists' ability to characterize findings is improved with the T scan, specifically by using jackknife alternative free-response receiver operating characteristic (JAFROC) methods. (Aim 2): Perform quantitative analysis of the 3D breast outline segmentation, texture, and density. With breast phantoms, we have previously shown that the breast volume is overestimated in the conventional scan and is calculated more accurately in the T scan. We aim to show that the same result holds in human subjects by calculating volume differences between the two scanning methods. Additionally, we will analyze power-law noise and higher-order non-Gaussian texture measures as surrogate metrics of detectability and tissue superposition effects, which we expect to be improved by the T scan. Finally, we will analyze whether percent density calculations differ between the two scanning methods since we expect fewer out-of-plane artifacts in the T scan. Although the new method of scanning is not being used as part of the volunteers' medical care, the overall impact of this study is to demonstrate improvements in specificity and thus the potential to minimize the number of diagnostic imaging exams and biopsies, lower healthcare costs, and minimize the total radiation dose combining screening and diagnostic imaging. Women with dense breasts will especially benefit from this new design since dense tissue can obscure findings in a conventional DBT scan, making them harder to characterize.

项目摘要 即使使用最新的数字乳腺断层合成摄影（DBT）系统，乳腺癌筛查仍然受到影响 因为特异性差。只有大约5%的妇女从筛查中被召回，最终发现有活检- 被证实的癌症临床DBT系统遭受图像质量的各向异性，因为扫描运动是 仅限于一个方向（从左到右）。我们建立了下一代断层合成（NGT）系统， 扫描成“T”形。通过假体和乳房切除术标本，我们已经表明，这种设计 减轻了超分辨率中的锥形束伪影、组织叠加效应和各向异性。作为下一步 在我们的研究中，我们将对志愿者进行一项试点研究，招募接受诊断成像的妇女 或活组织检查，以及妇女有简化的磁共振成像（MRI）。投影图像将 以这样的方式获得，我们可以从两种扫描方法（常规和T）生成重建。 每种扫描方法将由放射科医师在不同的阅读会话中单独分析。我们将减少 通过将研究限制在一个视图（头-尾）而不是两个视图，对辐射暴露的潜在担忧 意见.我们组建了一个具有独特优势的团队，包括NGT系统的开发人员， 三名放射科医生，两名统计学家，以及密度和纹理分析专家。这一建议分为两部分 具体目标。(Aim 1）：评估放射科医生在NGT系统志愿者试点研究中的表现。我们 将调查T扫描是否在不降低敏感性的情况下降低筛查的召回率。 放射科医生也将对恶性肿瘤的总体概率进行评分，并将这些评分结合分析 临床随访数据表明，放射科医生对T扫描结果的特征化能力得到了提高， 特别是通过使用折叠式替代自由响应接收器操作特性（JAFROC）方法。 (Aim 2）：对3D乳房轮廓分割、纹理和密度进行定量分析。乳腺 我们先前已经证明，在常规扫描中，乳房体积被高估， 在T扫描中计算得更准确。我们的目标是通过以下方式表明同样的结果在人类受试者中成立： 计算两种扫描方法之间的体积差异。此外，我们将分析幂律噪声 和高阶非高斯纹理测量作为可检测性和组织叠加的替代度量 效果，我们希望通过T扫描得到改善。最后，我们将分析百分比密度是否 两种扫描方法之间的计算不同，因为我们预期T扫描中的平面外伪影较少。 尽管这种新的扫描方法没有被用作志愿者医疗保健的一部分，但总体影响是， 本研究的目的是证明特异性的改善，从而有可能最大限度地减少 诊断成像检查和活检，降低医疗保健成本，并最大限度地减少总辐射剂量组合 筛查和诊断成像。乳房致密的女性将特别受益于这种新设计， 致密组织可能使常规DBT扫描中的发现模糊，使其难以表征。