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，新一代X射线成像技术 摘要 Imagine Scientific发明了STARLIGHT，这是一种受IP保护的单色X射线源， 显著改善了医学成像。这是一个期待已久的工程和科学突破， 用于诊断成像的实用、经济、临床单色X射线源。在其第一个临床 应用，它将用于X射线乳腺摄影，大大提高乳腺癌的筛查和诊断 癌使用STARLIGHT的乳腺X射线摄影系统将提供（i）对所有女性的肿瘤的上级检测， 包括那些厚而致密的乳房，（ii）显着降低辐射剂量，（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，每年有超过26万例新病例被诊断出来。 在美国.八分之一的女性在一生中会患上浸润性乳腺癌。40%-50%的女性有密集的 乳房（BI-RAD类别3和4 -高比例的腺体和纤维组织），增加其风险 患癌的几率会增加4到6倍。这些妇女的检测灵敏度水平为48%-64%，而 约85%的女性腺体较少，纤维乳腺组织含量低（BI-RAD类别1和2）。 STARLIGHT解决了由于目前的性能限制而导致的未满足的妇女健康需求 乳房X光检查系统。使用单色X射线的乳腺X射线摄影系统将提高检测灵敏度 在每年筛查的约4500万女性中，更高的灵敏度将降低 癌症的漏诊数量，而更高的特异性将大大降低错误诊断的数量。 阳性癌症检测和不必要的活检，转诊辅助超声和MRI 扫描，以及可避免的成本和受影响患者的高压力水平。除了一个更确凿的 诊断，使用基于STARLIGHT的乳腺X射线摄影系统筛查的女性将获得相当低的 放射剂量和经验乳房检查，而不经历痛苦的乳房压迫。单色 乳房X线摄影的上级性能有望大大降低与 误诊或晚期诊断的乳腺癌 STARLIGHT是第一种能够产生可选择的单色X射线的技术， 可集成到传统的2-D和3-D图像中， 乳房X光检查系统。制造基于STARLIGHT的乳腺X射线摄影系统的成本预计将 类似于目前的商用机器。 Imagine Scientific将设计、制造和建造先进的STARLIGHT单色X射线源 其强度至少是当前原型的10倍，使曝光时间在1到7秒之间。 它将被安装在一个商业乳房X线摄影系统，以证明上级图像质量和较低的 与目前的乳腺X射线摄影系统相比，