Melanoma detection by optical spectroscopy

描述(由申请人提供)： 这项研究的目标是开发、测试和验证一种基于光谱斜入射反射仪(OIR)的临床前非侵入性光学仪器，用于快速诊断癌前和侵袭性皮肤病变。我们强大的初步临床研究很好地支持了这一基本假设，即皮肤损伤的定量、空间分辨率、光学光谱(空间光谱)图像可以为皮肤科医生提供有临床价值的诊断信息，以补充他/她关于是否需要进一步诊断程序和/或治疗的临床判断。OIR故意打破了其正常入射对应物中存在的漫反射的对称性，因此提供了关于所询问的组织体积的更稳健的信息[Wang等，美国专利，5,630,423(1997)]。使用手持光纤探头对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/癌前病变和良性病变的准确率高于95%。申请人已经确定了关键的诊断生理参数为(1)血红蛋白的氧饱和度，(2)总血红蛋白的浓度，以及(3)细胞-核的大小。该方案的工程目标是改进原型OIR系统，以实时测量皮肤病变并对数据进行最佳处理，以实现准确的病变分类。该机制的目标是识别和量化对诊断光学特征负责的组织和细胞因素。临床目标是为临床难以诊断的良性、癌前病变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，降低医疗成本。具体目标如下。1.完善仪器设备。2.建立具有统计意义的数据库。3.开发和验证诊断算法。4.确定影响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.