SBIR Phase I: Dynamic Infrared-imaging of Skin Cancer (DISC)

这项小型企业创新研究第一阶段项目旨在开发一种新型的非侵入性诊断成像工具，用于皮肤癌的早期检测。在该项目中，将受控温度刺激应用于可疑病变，并使用先进的长波红外成像和分析系统（ALIAS）捕获热恢复过程，该系统能够测量0.02°C的温差。该方法的基本假设是，由于细胞增殖和热扩散、代谢增加和血流量过剩等异常过程产生热量，恶性细胞的动态温度反应将不同于周围正常皮肤细胞。第一阶段的工作将包括一项试点研究，以开发一种可量化的指标来捕捉温度曲线的差异，并研究是否可以使用该指标将基底细胞癌（BCC）、鳞状细胞癌（SCC）和恶性黑色素瘤（MM）等恶性病变与良性病变区分开来。该项目的更广泛影响/商业潜力将大大减少美国医疗保健行业的储蓄。对于数百万在皮肤上观察到可疑病变的人来说，目前皮肤科诊所唯一可用的选择要么是主观视觉检查，要么是侵入性活检。由于医生对任何临床非典型病变都进行活检以降低风险，因此活检的良性病变与确诊的黑色素瘤的比例为80比1。我们需要一种实时、无创、无痛的技术来弥补这一差距。所提出的方法是基于与癌症生长有关的基本量，即热量的产生。目前，我们在美国每年花费108亿美元用于皮肤癌活检，项目每年增长14%。如果这种方法成功，活组织检查的数量可以减少两倍，这将为美国医疗保健行业节省54亿美元。NSF SBIR资金将提供关键的过桥资金，使技术风险的降低能够吸引商业风险资本的资金。

This Small Business Innovation Research Phase I Project proposes to develop a novel non-invasive diagnostic imaging tool for the early detection of skin cancer. In this project, a controlled temperature stimulus is applied to the suspected lesion and the thermal recovery process is captured with an Advanced Longwave Infrared-imaging and Analysis System (ALIAS) capable of measuring temperature differences 0.02°C. The underlying hypothesis of this approach is that the dynamic temperature response of malignant cells will be different from that of the surrounding normal skin cells due to heat generation caused by abnormal processes such as cell proliferation and thermal diffusion, increased metabolism and excess blood flow. The Phase I effort will involve a pilot study to develop a quantifiable metric to capture the differences in the temperature curves and investigate whether malignant lesions such as Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) and Malignant Melanoma (MM) can be distinguished from benign lesions using this metric.The broader impact/commercial potential of this project would be a dramatic reduction in savings to the US health care industry. For millions of people who observe a suspicious lesion on their skin, the only options available today in the dermatology clinic are either a subjective visual test or an invasive biopsy. Since doctors perform biopsies on any clinically atypical lesions to minimize risk, the ratio of benign lesions biopsied to confirmed melanomas is 80 to 1. There is a need for a real-time, non-invasive, pain-free technology that can bridge this gap. The proposed approach is based on a fundamental quantity associated with cancer growth, namely heat generation. Currently, we spend $10.8B/year on skin cancer biopsies in the US along with a project increase of 14% increase annually. If this approach is successful and the number of biopsies can be decreased by a factor of two, it would represent a $5.4B savings to the US health care industry. The NSF SBIR funding will provide a critical bridge funding that will enable the reduction of technological risk to solicit commercial venture capitalist funding.