Hand-Held Infrared Scanner for Early Detection of Melanoma

用于早期检测黑色素瘤的手持式红外扫描仪

• 批准号: 8164366
• 负责人: Cila Herman
• 金额: $ 21.08万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-02 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8164366
• 关键词: Accounting; Affect; Applications Grants; Area; Benign; Biopsy; Biotechnology; Calibration; Cessation of life; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Computer Simulation; Computer software; Cutaneous; Cutaneous Melanoma; Data; Data Analyses; Dermatology; Dermoscopy; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Early Diagnosis; Early treatment; Engineering; Enhancing Lesion; Evaluation; Goals; Hand; Heating; Image; Image Analysis; Imagery; Imaging Device; Imaging Techniques; Imaging technology; Incidence; Individual; Intellectual Property; Lead; Lesion; Life Expectancy; Light; Longevity; Malignant - descriptor; Malignant Neoplasms; Masks; Measurement; Methods; Modeling; Mohs Surgery; Morbidity - disease rate; Neoplasm Metastasis; Numeric Rating Scale; Numerical value; Pathologist; Pathology; Patient Recruitments; Patients; Pigments; Probability; Public Health; Radiation therapy; Reading; Research; Resistance; Resolution; Scanning; Screening procedure; Sensitivity and Specificity; Simulate; Skin; Staging; System; Technology; Temperature; Testing; Three-Dimensional Image; United States; abstracting; advanced disease; base; chemotherapy; data modeling; design; high risk; improved; in vivo; lifetime risk; melanoma; mortality; novel; outcome forecast; prospective; prototype; research study; response; skin lesion; software development; tool; translational study

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.

描述(申请人提供)：用于黑色素瘤早期检测的手持式红外扫描仪项目摘要/摘要：黑色素瘤发病率正在以美国所有癌症中最快的速度增加，目前终生风险为1/58[1]。2010年将诊断出约68720例黑色素瘤，其中近8650例死亡[2]。目前，尚无可用于显著延长晚期疾病患者寿命的全身性药物，而改善所有受影响个体的存活率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性病变，目前对非典型病变的检测依赖于主观的ABCDE标准。因此，存在一种准确、简单、客观和定量的、非侵入性的筛查和诊断工具，对于在各种临床环境中早期发现恶性黑色素瘤将是非常宝贵的。我们假设恶性色素病变具有更高的增殖潜力，产生可量化的热量，并具有比周围正常皮肤更快复热的能力，从而创建黑色素瘤检测的标记。先前的PI研究，包括一项患者研究，表明对皮肤对冷刺激的瞬时热反应的高精度和分辨率可视化允许在疾病的早期阶段识别黑色素瘤皮损，并有望使用简单的数字标度(从1到10)来量化皮肤皮损的恶性潜能。在拟议的研究中，我们计划：1.设计、制造、校准和在患者研究中测试用于区分不同恶性潜能的色素病变的手持式高分辨率红外扫描仪原型2.进行患者研究，以建立基于对瞬时热反应的测量来描述色素病变恶性潜能的量化尺度3.开发和优化用于成像和定量评估不同恶性潜能的色素病变的软件和硬件本研究的长期目标是设计、建造和优化一种非侵入性、体内红外成像工具用于定量评估皮肤色素损害，以便启动大规模临床试验，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预计将导致一家专注于皮肤损伤红外成像的生物技术初创公司。 与公共健康相关：这项新的、合作的R01赠款提案旨在开发一种新的红外成像工具，一种高分辨率、高精度的手持扫描仪，以帮助临床检测和定量评估非典型色素病变，特别是黑色素瘤。翻译目标包括设计和制造原型设备，评估皮肤病变的高分辨率红外扫描在诊断色素病变以识别高危病变和黑色素瘤中的作用，以及优化这一扫描技术和支持诊断功能的计算模型。