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

这个小企业创新研究（SBIR）二期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，为致密乳房妇女提供有效和高效诊断乳腺癌所需的解剖学和功能信息。该设备采用了一种新颖的设计和方法，可以在低水平的辐射剂量下舒适地生成高质量的乳房解剖三维图像。通过设计，该设备将占用很小的空间，并支持快速高效的患者成像。当商业化时，它的价格可以与现有的基于x射线的成像技术相当。考虑到这些好处，以及全国范围内对一种彻底的致密乳房成像解决方案的巨大需求，它具有巨大的商业潜力。该项目的主要目标是显著提高致密性乳房妇女癌症放射学研究的敏感性和特异性。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方式的选择，无论在哪里进行成像，患者和临床医生都可以使用。这项小企业创新研究（SBIR）二期项目支持开发和验证一种舒适、有效、高密度的乳腺癌成像设备，该设备基于计算机断层扫描（CT）的新方法和设计。这种基于ct的设备不需要乳房压缩，并且比其他三维成像技术更小、更快、更高的空间分辨率。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的癌症，包括靠近胸部和腋下的区域。近50%的美国女性乳房致密。目前使用最广泛的乳房成像技术——乳房x线照相术和数字乳房断层合成术——无法满足这些女性的需求。这项技术不能可靠地成像靠近胸部和腋下发生癌症的乳房区域。目前的方法也不能可靠地区分健康但致密的乳腺组织和癌组织。在这个SBIR项目中，开发的设备的测试和验证将使用被称为拟人化幽灵的类人替代品进行。该公司将证明这项新技术提供高质量的致密组织成像，一致的全乳房成像和光谱信息，在癌症检测和诊断方面具有临床益处。该奖项反映了美国国家科学基金会的法定使命，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。

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.