Clinical Translation of High Energy Phase-Sensitive X-ray Breast Tomosynthesis

高能相敏X射线乳腺断层合成的临床转化

• 批准号: 9263567
• 负责人: Laurie L Fajardo
• 金额: $ 49.54万
• 依托单位: UNIVERSITY OF OKLAHOMA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2020-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9263567
• 关键词: Algorithms; Area; Base Ratios; Biopsy; Breast; Breast Cancer Detection; Breast Microcalcification; Cadaver; Cancer Detection; Characteristics; Cities; Clinical; Data Set; Diagnosis; Digital Breast Tomosynthesis; Dose; Emerging Technologies; Equilibrium; Evaluation; FDA approved; Frequencies; Future; Geometry; Goals; Gold; Health; Histopathology; Image; Industry Collaboration; Journals; Lesion; Literature; Malignant Neoplasms; Mammary Gland Parenchyma; Mammography; Measures; Methods; Motion; Motivation; Noise; Outcome; Paper; Patient Schedules; Patients; Performance; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Photons; Probability; Procedures; Publications; Radiation; Reader; Research; Resolution; Retrieval; Roentgen Rays; Sample Size; Savings; Scanning; Screening for cancer; Selenium; Sensitivity and Specificity; Solid; Source; Statistical Data Interpretation; Structure; Synchrotrons; System; Techniques; Technology; Testing; Thick; Time; Tissues; Translating; Translations; Tube; attenuation; base; breast cancer diagnosis; breast imaging; breast lesion; calcification; clinical application; clinical practice; detector; image reconstruction; imaging system; improved; innovation; novel strategies; pre-clinical; preclinical evaluation; preference; prototype; radiologist; reconstruction; research clinical testing; voltage

 DESCRIPTION (provided by applicant): The objective of the project is to translate a phase-sensitive x-ray tomosynthesis technique to clinical practice to reduce radiation dose and improve accuracy in breast cancer diagnosis. The technique is based on the principle of inline phase-sensitive x-ray imaging operating at high energies of 120 to 150 kVp. We will build a patient imaging system and conduct preclinical evaluations and phase 1 clinical trial. As the result of more than 20 years of research, digital breast tomosynthesis (DBT) was recently approved by the FDA and introduced into clinical practice. The key advantage of DBT as compared with projection mammography is its 3D capability that effectively removes the superimposed breast parenchymal structures and improves the conspicuity and detection of breast cancer. However, there are two main limitations with DBT. The first regards its ability to detect subtle breast calcifications, and the second involves the higher radiation dose as compared with conventional mammography. It is therefore necessary to improve the sensitivity and specificity of DBT and reduce the radiation dose to patients. It has been shown that tissue- lesion contrast based on x-ray phase-shifts is greater than the corresponding attenuation contrast. In addition, while low x-ray energies must be used in conventional attenuation-based breast imaging, high x-ray energies can be used in phase-sensitive imaging to reduce the radiation dose. We therefore propose the integration of innovative phase-sensitive methods with DBT. The hypothesis of our proposal is that high energy phase-sensitive breast tomosynthesis (PBT) can greatly enhance tissue contrast and significantly reduce radiation dose as compared to current digital breast tomosynthesis (DBT). To test our hypotheses, we will (1) assemble a high energy (120-150 KV) x-ray phase- sensitive breast tomosynthesis system with a micro-focus tube source and a high-resolution flat panel detector; (2) optimize the phase retrieval algorithm and test it under clinical patient imaging conditions; (3) characterize the performance of the patient imaging system and its key components for system optimization, and compare the proposed system with DBT to determine radiation dose savings; (4) conduct subjective preclinical evaluations with cadaver and other phantoms to determine the optimal operating parameters for patient studies; (5) conduct a Phase 1 clinical evaluation and statistical analysis with 110 patients to compare phase- sensitive and conventional tomosynthesis systems. The proposed research will facilitate the translation of this innovative phase-sensitive breast tomosynthesis technique to clinical practice, and enhance the sensitivity and specificity of breast cancer detection while also reducing the radiation dose.

 描述（由适用提供）：该项目的目的是将相关的X射线合成技术转化为临床实践，以降低辐射剂量并提高乳腺癌诊断的准确性。该技术基于内联相位敏感的X射线成像的原理，以120至150 kVp的高能运行。我们将建立一个患者成像系统，并进行临床前评估和第1阶段临床试验。由于研究了20多年的研究，数字乳房间压合成（DBT）最近得到了FDA的批准，并引入了临床实践。与投影乳房X线摄影相比，DBT的主要优势在于其3D能力有效地消除了叠加的乳房实质结构并改善了乳腺癌的阴离和检测。但是，DBT有两个主要局限性。第一个涉及其检测微妙的乳腺钙化的能力，与常规乳房X线摄影相比，第二个涉及较高的辐射剂量。因此，有必要提高DBT的敏感性和特异性并减少对患者的辐射剂量。已经表明，基于X射线相移的组织对比大于相应的衰减对比度。此外，虽然必须将低X射线能量用于常规的基于衰减的乳房成像，但高X射线能量可用于相敏感成像中以减少辐射剂量。因此，我们建议将创新的相位敏感方法与DBT整合。我们提出的假设是，与当前数字乳房合成（DBT）相比，高能量相敏感的乳腺乳房合成（PBT）可以极大地增强组织对比度并显着降低辐射剂量。为了检验我们的假设，我们将（1）组装一个高能量（120-150 kV）X射线相位敏感的乳腺乳房合成系统，该系统具有微焦管源和高分辨率的平板检测器； （2）优化相位检索算法并在临床患者成像条件下进行测试； （3）表征患者成像系统的性能及其以进行系统优化的关键组件，并将提出的系统与DBT进行比较以确定辐射剂量的节省； （4）对尸体和其他幻影进行主观临床前评估，以确定患者研究的最佳操作参数； （5）对110名患者进行1期临床评估和统计分析，以比较相敏感和常规的间质系统。拟议的研究将促进这种创新的相位敏感乳房合成技术转化为临床实践，并提高乳房的敏感性和特异性 癌症检测，同时还减少了辐射剂量。