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: 8860536
• 负责人: Laurie L Fajardo
• 金额: $ 59.88万
• 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/8860536
• 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; 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; Solutions; Source; 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; public health relevance; 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（由申请人提供）：该项目的目标是将相敏 X 射线断层合成技术应用于临床实践，以减少辐射剂量并提高乳腺癌诊断的准确性。在120至150 kVp的高能量下运行的敏感X射线成像我们将建立一个患者成像系统并进行临床前评估和1期临床试验作为20多年的结果。研究表明，数字乳腺断层合成（DBT）最近获得 FDA 批准并引入临床实践，与投影乳腺 X 线摄影相比，DBT 的主要优势在于其 3D 功能，可以有效去除叠加的乳腺实质结构，提高乳腺的显见度和检测能力。然而，DBT 有两个主要局限性，第一个是其检测细微乳房钙化的能力，第二个是与传统乳房 X 光检查相比，辐射剂量更高。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射线相移的组织病变对比度大于相应的衰减对比度此外，同时低X射线能量必须。与传统的基于衰减的乳腺成像相比，高 X 射线能量可用于相敏成像，以减少辐射剂量。因此，我们建议将创新的相敏方法与 DBT 相结合。我们建议的假设是：高能相敏乳腺与当前的数字乳腺断层合成 (DBT) 相比，断层合成 (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) 组装高能 (120-150 KV) X 射线相位 -具有微焦管源和高分辨率平板探测器的灵敏乳腺断层合成系统（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）表征患者成像系统及其关键组件进行系统优化，并将所提出的系统与 DBT 进行比较，以确定辐射剂量节省；(4) 对尸体和其他模型进行主观临床前评估，以确定患者研究的最佳操作参数；对 110 名患者进行一期临床评估和统计分析，以比较相敏和传统断层合成系统。拟议的研究将有助于将这种创新的相敏乳腺断层合成技术实践转化为临床实践，并提高敏感性。以及乳房的特殊性 癌症检测的同时还减少了辐射剂量。