SBIR Phase II: Non-planar Spectral Breast Computed Tomography (CT)

SBIR 第二阶段：非平面光谱乳腺计算机断层扫描 (CT)

• 批准号: 2241912
• 负责人: Peymon Ghazi
• 金额: $ 100万
• 依托单位: MALCOVA INC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2241912&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Non; planar

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to make available to the public a new imaging device that provides the anatomical and functional information necessary for effective and efficient diagnosis of breast cancer in women with dense breasts. The device employs a novel design and method of generating high-quality, three-dimensional images of the breast anatomy comfortably and at low levels of radiation dose. By design, the device will occupy a small space and support fast and efficient patient imaging. When commercialized, it can be priced on par with existing x-ray-based imaging technologies. Given these benefits and the large existing need nationwide need for a thorough dense-breast imaging solution, there is significant commercial potential. The prime objective of the project is to significantly increase the sensitivity and specificity in cancer radiological studies of women with dense breasts. Accordingly, this device has the potential to become the next generation breast cancer imaging modality of choice for small clinics as well as large hospitals, available to both patients and clinicians everywhere imaging is performed.This Small Business Innovation Research (SBIR) Phase II project supports development and validation of a comfortable, effective, dense-breast cancer imaging device built upon a new method and design for Computed Tomography (CT). This CT-based device does not require breast compression, and is smaller, faster, and higher in spatial resolution than alternative 3-dimensional imaging technologies. The instrument will provide spectral information used to distinguish deadly from non-deadly cancers from both dense and non-dense tissues across the entire breast, including regions near the chest and underarm. Nearly 50% of the U.S. female population has dense breasts. The most widely used technologies for breast imaging today —Mammography and Digital Breast Tomosynthesis — underserve these women. This technology cannot reliably image breast regions near the chest and underarm where cancers occur. Current methods also cannot reliably distinguish healthy, but dense, breast tissue from cancer. During this SBIR project, testing and validation of the developed device will be carried out using human-like surrogates called anthropomorphic phantoms. The company will demonstrate that this new technology provides high quality dense-tissue imaging, consistent whole-breast imaging, and spectral information that is of clinical benefit in cancer detection and diagnosis.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是向公众提供一种新的成像设备，提供有效和高效诊断致密乳房女性乳腺癌所需的解剖和功能信息。该设备采用了一种新颖的设计和方法，可以舒适地生成乳房解剖结构的高质量三维图像，并且辐射剂量水平较低。通过设计，该设备将占用较小的空间，并支持快速有效的患者成像。当商业化时，它的价格可以与现有的基于X射线的成像技术相提并论。考虑到这些好处以及全国范围内对全面致密乳腺成像解决方案的巨大需求，这一方案具有巨大的商业潜力。该项目的主要目标是显著提高对乳腺致密妇女进行癌症放射学研究的灵敏度和特异性。因此，该设备有可能成为小型诊所和大型医院的下一代乳腺癌成像模式的选择，可供患者和临床医生在任何地方进行成像。该小型企业创新研究（SBIR）第二阶段项目支持开发和验证一种舒适，有效，高密度乳腺癌成像设备建立在计算机断层扫描（CT）的新方法和设计基础上。这种基于CT的设备不需要乳房压迫，并且比其他三维成像技术更小，更快，空间分辨率更高。该仪器将提供光谱信息，用于从整个乳房的致密和非致密组织中区分致命和非致命癌症，包括胸部和腋下附近的区域。近50%的美国女性拥有致密的乳房。目前使用最广泛的乳腺成像技术--乳腺X射线摄影和数字乳腺断层合成摄影--对这些妇女的服务不足。该技术不能可靠地对发生癌症的胸部和腋下附近的乳房区域进行成像。 目前的方法也不能可靠地区分健康但致密的乳腺组织与癌症。在这个SBIR项目中，将使用称为拟人幻影的类人替代品对开发的设备进行测试和验证。该公司将证明这项新技术提供了高质量的致密组织成像，一致的全乳房成像，以及在癌症检测和诊断中具有临床效益的光谱信息。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。