Melanoma detection by optical spectroscopy

描述（由申请人提供）： 拟议研究的目标是开发，测试和验证一种基于光谱斜入射反射法（OIR）的临床前非侵入性光学仪器，用于癌前和侵入性癌性皮肤病变的快速诊断。基本假设，这是很好地支持我们的初步临床研究，是定量，空间分辨，光谱（空间光谱）图像的皮肤病变可以提供临床有价值的诊断信息，以补充他/她的临床判断需要进一步的诊断程序和/或治疗的皮肤科医生。OIR有意地打破了其垂直入射对应物中存在的漫反射的对称性，并且因此提供了关于所询问的组织体积的更鲁棒的信息[Wang等人，美国专利，5，630，423（1997）]。使用手持式光纤探头对102个皮肤病变进行的初步临床研究表明，OIR光谱系统区分癌性/癌前皮肤病变和良性病变的准确率超过95%。申请人已确定关键诊断生理参数为（1）血红蛋白的氧饱和度，（2）总血红蛋白浓度，和（3）细胞核大小。该提案的工程目标是改进原型OIR系统，以实时测量皮肤病变并最佳地处理数据以进行准确的病变分类。机械目标是识别和量化负责诊断光学特征的组织和细胞因子。临床目标是为临床上难以诊断的良性、癌前和恶性病变提供准确、客观和实时的诊断。最终的社会影响是改善患者护理，拯救生命，降低医疗保健成本。具体目标如下。1.改进仪器。2.建立具有统计意义的数据库。3.开发并验证诊断算法。4.确定负责诊断光学特征的病理生理参数。

DESCRIPTION (provided by applicant): The goal of the proposed research is to develop, test, and validate a preclinical non-invasive optical instrument, based on spectroscopic Oblique Incidence Reflectometry (OIR), for the rapid diagnosis of pre-cancerous and invasive cancerous skin lesions. The underlying hypothesis, which is well supported by our strong preliminary clinical studies, is that quantitative, spatially resolved, optical-spectral (spatio-spectral) images of skin lesions can provide the dermatologist with clinically valuable diagnostic information to supplement his/her clinical judgment about the need for further diagnostic procedures and/or treatments. OIR intentionally breaks the symmetry of diffuse reflectance that exists in its normal-incidence counterpart and, as a result, provides more robust information about the interrogated tissue volume [Wang et al, US Patent, 5,630,423 (1997)]. A preliminary clinical study of 102 skin lesions using a handheld fiber-optic probe showed that the OIR spectroscopic system differentiated cancerous/pre-cancerous skin lesions from benign lesions with better than 95% accuracy. The applicants have identified the key diagnostic physiological parameters to be (1) the oxygen saturation of hemoglobin, (2) the concentration of total hemoglobin, and (3) the cell-nuclear size. The engineering goal of this proposal is to improve the prototype OIR system to measure skin lesions in real-time and process the data optimally for accurate lesion classification. The mechanistic goal is to identify and quantify the tissue and cellular factors that are responsible for the diagnostic optical features. The clinical goal is to provide accurate, objective, and real-time diagnoses for benign, pre-cancerous, and malignant lesions that are difficult to diagnose clinically. The ultimate societal impact is to improve patient care, save lives, and reduce health care costs. The Specific Aims are listed as follows. 1. To improve instrumentation. 2. To establish a statistically significant database. 3. To develop and validate a diagnostic algorithm. 4. To identify the pathophysiologic parameters responsible for the diagnostic optical features.