Hand-Held Infrared Scanner for Early Detection of Melanoma

项目摘要/摘要：在美国，黑色素瘤的发病率增长速度是所有癌症中最快的之一，目前的终生风险为1 / 58。2010年将诊断出大约68,720例黑色素瘤，其中近8,650例导致死亡。目前，还没有能够显著延长晚期疾病患者寿命的全身性药物，提高所有受影响个体生存的关键仍然是早期诊断和治疗。绝大多数皮肤黑色素瘤表现为皮肤的色素病变，目前非典型病变的检测依赖于主观的ABCDE标准。因此，一种准确、简单、客观、定量、非侵入性的筛查和诊断工具的存在，对于各种临床环境中恶性黑色素瘤的早期检测将是非常宝贵的。我们假设，具有增加增殖潜力的恶性色素病变产生可量化的热量，并且具有比周围正常皮肤更快地重新加热的能力，从而创造了黑色素瘤检测的标记。PI先前的研究，包括一项患者研究，表明皮肤对冷却激发的瞬态热反应的高精度和高分辨率可视化允许在疾病的早期阶段识别黑色素瘤病变，并有望使用简单的数值尺度（从1到10）量化皮肤病变的恶性潜力。在提出的研究中，我们计划：1。设计、制造、校准并在患者研究中测试一台原型手持式高分辨率红外扫描仪，用于区分不同恶性潜能的色素病变2。对患者进行研究，建立基于瞬时热反应测量的描述色素病变恶性潜能的定量尺度3。本研究的长期目标是设计、构建和优化一种无创的体内红外成像工具，用于皮肤色素病变的定量评估，以便开展大规模的临床试验，以评估和比较所提出的工具与其他体内诊断和成像技术的敏感性和特异性。这种工具有望减少良性色素病变的不必要的皮肤活检，以及与黑色素瘤诊断和治疗相关的发病率和死亡率。一个跨学科团队将参与研究工作：两名工程师将负责软件和硬件的开发以及建模工作，三名具有皮肤科专业知识的临床医生将领导患者研究的患者招募工作，一名来自公共卫生领域的专家将领导临床试验设计、实施和数据分析工作。通过这些研究产生的知识产权有望催生一家专注于皮肤病变红外成像的生物技术初创公司。

DESCRIPTION (provided by applicant): Hand-held infrared scanner for early detection of melanoma Project Summary/Abstract: Melanoma incidence is increasing at one of the fastest rates for all cancers in the United States, with a current lifetime risk of 1 in 58 [1]. Approximately 68,720 melanomas will be diagnosed in 2010, with nearly 8,650 resulting in death [2]. At present, there are no systemic agents available that significantly extend the lifespan of patients with advanced disease and the key to improved survival in all affected individuals remains early diagnosis and treatment. The vast majority of cutaneous melanomas present as pigmented lesions of the skin, and current detection of atypical lesions rely on the subjective ABCDE criteria. The existence of an accurate, simple, objective and quantitative, non-invasive screening and diagnostic tool would therefore be invaluable for the early detection of malignant melanoma in a variety of clinical settings. We hypothesize that malignant pigmented lesions with increased proliferative potential generate quantifiable amounts of heat and possess an ability to reheat more quickly than the surrounding normal skin, thereby creating a marker for melanoma detection. Prior research of the PI, involving a patient study, suggests that the high-accuracy and resolution visualization of the transient thermal response of the skin to a cooling excitation allows for the identification of melanoma lesions in an early stage of the disease and holds the promise of quantifying the malignant potential of skin lesions using a simple numerical scale (from 1 to 10). In the proposed study we plan to: 1. Design, build, calibrate and test in a patient study a prototype hand-held, high-resolution infrared scanner for distinguishing pigmented lesions of varying malignant potential 2. Conduct a patient study to establish quantitative scale describing the malignant potential of a pigmented lesion based on measurement of the transient thermal response 3. Develop and optimize the software and hardware for the imaging and quantitative assessment of pigmented lesions of varying malignant potential The long-term goals of this study are to design, build and optimize a noninvasive, in vivo infrared imaging tool for the quantitative assessment of cutaneous pigmented lesions in order initiate large-scale clinical trials to evaluate and compare the sensitivity and specificity of the proposed tool with other in vivo diagnostic and imaging techniques. Such a tool is expected to decrease unnecessary skin biopsies of benign pigmented lesions and the morbidity and mortality associated with melanoma diagnosis and therapy. An interdisciplinary team will be involved in the research effort: two engineers will be responsible for the development of software and hardware and the modeling effort, three clinicians with expertise in dermatology will be leading the patient recruitment effort for the patient study, and one expert from the public health area will be leading the clinical trial design, conduct, and data analysis efforts. Intellectual property generated through these studies is expected to lead to a biotechnology startup company focused on infrared imaging of cutaneous lesions. PUBLIC HEALTH RELEVANCE: This new, collaborative R01 grant proposal seeks to develop a novel infrared imaging tool, a high-resolution, high-accuracy, hand-held scanner, to aid in the clinical detection and quantitative assessment of atypical pigmented lesions, and melanoma in particular. Translational goals include the design and manufacturing of a prototype device, the evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions to identify high-risk lesions and melanomas and optimization of this scanning technology and the computational model supporting the diagnostic feature.