STARLIGHT, The Next Generation X-ray Imaging Technology

STARLIGHT，下一代 X 射线成像技术

• 批准号: 10384060
• 负责人: Eric Silver
• 金额: $ 105.75万
• 依托单位: IMAGINE SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384060
• 关键词: 3-Dimensional; Address; Adjuvant; Affect; Biopsy; Breast; Cancer Detection; Categories; Chemicals; Clinical; Detection; Diagnosis; Diagnostic Imaging; Diagnostic X-Ray; Engineering; Goals; Image; Imaging technology; Low Dose Radiation; MRI Scans; Malignant Neoplasms; Mammary Gland Parenchyma; Mammography; Manufacturer Name; Medical Imaging; Modification; Morbidity - disease rate; Pain; Patients; Peer Review; Performance; Procedures; Risk; Roentgen Rays; Series; Small Business Innovation Research Grant; Source; Specificity; Stress; System; Technology; Testing; Thick; Time; Tissues; Ultrasonography; Woman; Women' s Health; X-Ray Medical Imaging; base; breast cancer diagnosis; breast exam; breast imaging; cancer diagnosis; clinical application; cost; cost effective; design; detection sensitivity; experience; imaging facilities; improved; in vivo; journal article; malignant breast neoplasm; next generation; programs; prototype; safety testing; screening; tumor

STARLIGHTTM, The Next Generation X-ray Imaging Technology ABSTRACT Imagine Scientific has invented STARLIGHT, an IP-protected monochromatic X-ray source that will significantly improve medical imaging. It is a long-awaited engineering and scientific breakthrough, and the first practical, cost-effective, clinical source of monochromatic X-rays for diagnostic imaging. In its first clinical application, it will be used in X-ray mammography to considerably advance screening and diagnosis of breast cancer. Mammography systems using STARLIGHT will offer (i) superior detection of tumors for all women, including those with thick and dense breasts, (ii) significantly lower radiation dose, (iii) elimination of painful breast compression during examinations, and (iv) chemical analysis of tissue in-vivo. Breast cancer is the most common cancer in women, with over 260,000 new cases diagnosed each year in the US. 1 in 8 women will develop invasive breast cancer during their lifetime. 40%-50% of women have dense breasts (BI-RAD categories 3 and 4 - high proportion of glandular and fibrous tissue), increasing their risk of developing cancer by 4 to 6 times. The detection sensitivity level for these women is 48%-64%, compared to ~ 85% for women with less glandular and low amounts of fibrous breast tissue (BI-RAD categories 1 and 2). STARLIGHT addresses unmet women’s health needs caused by the performance limitations of current mammography systems. Mammography systems using monochromatic X-rays will improve detection sensitivity for early-stage cancers in the ~45 million women screened each year (US). Higher sensitivity will reduce the number of missed diagnoses of cancer, while higher specificity will considerably lower the number of false positive cancer detections and the unnecessary resulting biopsies, referrals for adjuvant ultrasound and MRI scans, and avoidable costs and high stress levels for affected patients. In addition to a more conclusive diagnosis, women screened with STARLIGHT-based mammography systems will receive considerably lower radiation dose and experience breast exams without undergoing painful breast compression. Monochromatic mammography’s superior performance is expected to substantially reduce morbidity associated with misdiagnosed or late-diagnosed breast cancer. STARLIGHT is the first technology capable of producing selectable, monochromatic X-rays with the required intensity for full-field mammography and can be integrated into conventional 2-D and 3-D mammography systems. The cost to manufacture a STARLIGHT-based mammography system is expected to be similar to current commercial machines. Imagine Scientific will design, fabricate and build an advanced STARLIGHT monochromatic X-ray source with at least 10 times the intensity of the current prototype, enabling exposure times between 1 and 7 seconds. It will be installed in a commercial mammography system, to demonstrate superior image quality and lower radiation doses compared to current mammography systems.

STARLIGHTTM--下一代X射线成像技术 摘要 Imagine Science发明了Starlight，这是一种受知识产权保护的单色X射线源，将 显著提高医学成像水平。这是人们期待已久的工程和科学突破，也是第一个 用于诊断成像的实用、经济高效的临床单色X射线源。在它的第一个临床 应用，它将用于X光乳房X光摄影，大大提高乳房的筛查和诊断 癌症。使用Starlight的乳房X光照相系统将为所有女性提供(I)卓越的肿瘤检测， 包括那些乳房肥厚和致密的人，(Ii)显著降低辐射剂量，(Iii)消除疼痛 检查期间的乳房压迫，以及(Iv)体内组织的化学分析。 乳腺癌是女性最常见的癌症，每年新增确诊病例超过26万例 在美国。每8名女性中就有1名会在一生中患上浸润性乳腺癌。40%-50%的女性患有肥胖症 乳房(BI-RAD 3和4类-腺体和纤维组织比例较高)，增加了患乳腺癌的风险 罹患癌症的几率增加4到6倍。这些女性的检测敏感度水平为48%-，而 腺体较少、乳腺纤维组织数量较少的女性(BI-RAD 1和2类)的比例为85%。 Starlight解决了由于当前性能限制而导致的未得到满足的女性健康需求 乳房X光检查系统。使用单色X射线的乳房X光摄影系统将提高检测灵敏度 每年筛查约4500万名妇女的早期癌症(美国)。较高的敏感度将降低 癌症的漏诊数量，而更高的特异性将显著降低错误数量 癌症检测阳性和不必要的活检，转诊为辅助超声和核磁共振 扫描，以及可避免的费用和受影响患者的高压力水平。除了更具说服力的 诊断，使用基于星光的乳房X光检查系统进行筛查的女性将得到相当低的 辐射剂量和体验乳房检查，而不经历痛苦的乳房按压。单色 乳房X光检查的卓越性能有望大幅降低与以下疾病相关的发病率 误诊或诊断较晚的乳腺癌。 Starlight是第一种能够产生可选择的单色X射线的技术 全视野乳房X光摄影所需的强度，并可集成到传统的2-D和3-D 乳房X光检查系统。制造基于Starlight的乳房X光检查系统的成本预计将 类似于目前的商业机器。 Imagine Science将设计、制造和制造先进的星光单色X射线源 强度至少是当前原型的10倍，使曝光时间在1至7秒之间。 它将安装在商业乳房X光照相系统中，以展示更高的图像质量和更低的 与目前的乳房X光照相系统相比，辐射剂量。