Combined raman spectroscopy-optical tomagraphy for complete diagnosis of skin can

拉曼光谱-光学断层扫描相结合，可对皮肤进行全面诊断

• 批准号: 7623181
• 负责人: Anita Mahadevan-Jansen
• 金额: $ 13.12万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-06-01 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7623181
• 关键词: Anxiety; Appearance; Area; Basal cell carcinoma; Benchmarking; Benign; Biochemical; Biopsy; Breast; Cancer Detection; Cancerous; Cervix Uteri; Clinic Visits; Clinical; Clinical Course of Disease; Confocal Microscopy; Data; Data Set; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Differential Diagnosis; Diffuse; Discrimination; Disease; Disease Management; Early Diagnosis; Ensure; Epithelial; Evaluation; Excision; Fluorescence; Foundations; Gastrointestinal tract structure; Goals; Healthcare; Histology; Histopathology; Image; Imaging Techniques; In Vitro; Incidence; Individual; Lasers; Lesion; Location; Malignant - descriptor; Malignant Neoplasms; Maps; Measurement; Measures; Medicine; Methods; Microscopic; Modality; Molecular; Monitoring for Recurrence; Nature; Noise; Operative Surgical Procedures; Optical Coherence Tomography; Optics; Organ; Output; Ovary; Pathology; Pathology Report; Patient Care; Patients; Perception; Performance; Phase; Physical Examination; Physicians; Pigments; Pilot Projects; Prostate; Protocols documentation; Radar; Raman Spectrum Analysis; Reporting; Research; Resolution; Risk; Sampling; Screening for Skin Cancer; Screening procedure; Signal Transduction; Site; Skin; Skin Cancer; Source; Specificity; Spectrum Analysis; Speed; Staging; Surface; System; Techniques; Technology; Testing; Thick; Time; Tissue Sample; Tissues; Training; Underserved Population; Upper arm; Validation; Visible Radiation; Work; cancer diagnosis; clinical practice; cost effectiveness; data acquisition; design; detector; flexibility; follow-up; imaging modality; improved; in vivo; innovation; instrument; interest; meetings; miniaturize; novel; optical imaging; outcome forecast; public health relevance; rapid detection; skin lesion; spectroscopic imaging; success; tool; Anxiety; Appearance; Area; Basal cell carcinoma; Benchmarking; Benign; Biochemical; Biopsy; Breast; Cancer Detection; Cancerous; Cervix Uteri; Clinic Visits; Clinical; Clinical Course of Disease; Confocal Microscopy; Data; Data Set; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Differential Diagnosis; Diffuse; Discrimination; Disease; Disease Management; Early Diagnosis; Ensure; Epithelial; Evaluation; Excision; Fluorescence; Foundations; Gastrointestinal tract structure; Goals; Healthcare; Histology; Histopathology; Image; Imaging Techniques; In Vitro; Incidence; Individual; Lasers; Lesion; Location; Malignant - descriptor; Malignant Neoplasms; Maps; Measurement; Measures; Medicine; Methods; Microscopic; Modality; Molecular; Monitoring for Recurrence; Nature; Noise; Operative Surgical Procedures; Optical Coherence Tomography; Optics; Organ; Output; Ovary; Pathology; Pathology Report; Patient Care; Patients; Perception; Performance; Phase; Physical Examination; Physicians; Pigments; Pilot Projects; Prostate; Protocols documentation; Radar; Raman Spectrum Analysis; Reporting; Research; Resolution; Risk; Sampling; Screening for Skin Cancer; Screening procedure; Signal Transduction; Site; Skin; Skin Cancer; Source; Specificity; Spectrum Analysis; Speed; Staging; Surface; System; Techniques; Technology; Testing; Thick; Time; Tissue Sample; Tissues; Training; Underserved Population; Upper arm; Validation; Visible Radiation; Work; cancer diagnosis; clinical practice; cost effectiveness; data acquisition; design; detector; flexibility; follow-up; imaging modality; improved; in vivo; innovation; instrument; interest; meetings; miniaturize; novel; optical imaging; outcome forecast; public health relevance; rapid detection; skin lesion; spectroscopic imaging; success; tool

DESCRIPTION (provided by applicant): The incidence of skin cancer has been on the rise in recent years and as in most cancers, early diagnosis and thorough treatment (i.e., complete resection) are the keys to gain a favorable prognosis. Current diagnostic methods for skin cancers rely on physical examination in conjunction with skin biopsy, methods that have limited accuracy in early diagnosis. Hence there is considerable interest in developing a non-invasive diagnostic and screening tool, which can accurately recognize skin cancer in its early stages. Such a tool would not only detect early signs of malignancy, it will also reduce unnecessary diagnostic surgical procedures, facilitate complete excision of skin cancers by accurately delineating the skin cancer margins prior to and during the surgery, and allow treated patients to be monitored for recurrence. In this proposal we present a method that combines Optical Coherence Tomography (OCT), an imaging technique that visualizes tissue microstructure, with Raman spectroscopy, a spectroscopy technique that provides a tissue biochemical map in a single portable instrument for the effective detection of skin lesions. The real-time non-invasive nature of this combined technique can enable a "see and treat" protocol that would decrease the number of return clinic visits and patient anxiety as the long waits for histopathology diagnoses would be eliminated. Thus, the technology has the potential to increase access to underserved populations where follow-up to screening may not be available. The technology poses no known risks to the patient, and therefore could be a safe alternative to current screening methods. PUBLIC HEALTH RELEVANCE: The incidence of skin cancer has been on the rise in recent years and as in most cancers, early diagnosis and thorough treatment (i.e., complete resection) are the keys to gain a favorable prognosis. Current diagnostic methods for skin cancers rely on physical examinations in conjunction with skin biopsy, methods that have limited accuracy for early diagnosis. Hence there is considerable interest in developing a non- invasive diagnostic and screening tool, which can accurately recognize skin cancer in its early stages. Such a tool would not only detect early signs of malignancy, it could also reduce unnecessary diagnostic surgical procedures, facilitate complete excision of skin cancers by accurately delineating the skin cancer margins prior to and during the surgery, and allow treated patients to be monitored for recurrence. Initial reports have identified the practical limitations of non-invasive optical devices using either imaging or spectroscopy to evaluate the diverse clinical appearance of normal skin, benign lesions, and malignancy. In this proposal, we describe the design of a device that is specifically geared towards thorough non-invasive analysis of both the underlying microstructure and biochemical composition of the skin. The challenge presented by the variability of skin and skin cancers present the ideal test organ and pathology for the proposed multi-modal device. This R21 proposal seeks to validate the hypothesis that a device that combines morphological imaging with optical coherence tomography (OCT) and biochemical evaluation with Raman spectroscopy (RS) increases the diagnostic information available to the physician and could improve the diagnostic performance of each technique alone. The feasibility phase of this project is designed towards the development of a combined RSOCT system and the validation of such a combined imaging method for the detection of skin cancers. The specific aims are designed towards quantifiable and achievable milestones that will demonstrate the potential of such an approach towards cancer diagnosis in general and skin cancer detection in particular. Specific Aim #1: Develop and test a benchtop combined RS-OCT system: A benchtop version of the combined system will be developed on the platform of a Fourier Domain-OCT spectral radar system consisting of two sources but a single detector and sample arm. The performance of both OCT and RS will each be compared with benchmark values of existing in vivo systems. Specific Aim #2: Develop an RSOCT handheld probe for in vivo application: In order to test the utility of such a multi-modal system in vivo, a handheld probe will be developed and the entire system made portable to allow for flexibility of measurements from hard to reach lesion sites. The performance of both OCT and RS will each be compared with benchmark values of the benchtop system. Specific Aim #3: Conduct a pilot study on 30 patients with suspected basal cell carcinomas (BCCs) to demonstrate the utility RS-OCT: A small pilot study will evaluate the validity of the combined device in clinical practice where lesions suspected of BCCs will be assessed with RS alone, OCT alone, and combined RS-OCT. The ability of RS to discriminate between normal benign and malignant lesions will be compared with OCT guided RS. The specific aims described above will demonstrate the potential of RSOCT for the diagnosis and possible screening of skin cancers. The proposed work will have a significant impact on health care by providing the potential for complete disease management with a single detection tool. This would result in improved patient care and cost-effectiveness. With the success of this technique, RSOCT can be applied to other organ sites such as the breast, prostate and ovary as well as other diseases thus impacting a broader field in medicine.

描述（由申请人提供）：近年来，皮肤癌的发生率一直在增加，与大多数癌症一样，早期诊断和彻底治疗（即完全切除）是获得有利预后的关键。当前针对皮肤癌的诊断方法依赖于身体检查以及皮肤活检，这些方法在早期诊断中的准确性有限。因此，人们对开发非侵入性诊断和筛查工具具有很大的兴趣，该工具可以在早期阶段准确识别皮肤癌。这样的工具不仅可以检测到早期的恶性肿瘤迹象，还将减少不必要的诊断手术程序，从而促进手术前和手术过程中准确划定皮肤癌边缘的皮肤癌的完全切除，并允许对患者进行治疗的患者进行监测。在此提案中，我们提出了一种结合光学相干断层扫描（OCT）的方法，该方法是一种可视化组织微观结构的成像技术，以及拉曼光谱（Raman Spectrecopicy），这是一种在单个便携式仪器中提供组织生物化学图的观察力技术，可有效检测皮肤病变。这种组合技术的实时非侵入性质可以实现“ See and Tornes”方案，该方案将减少回程诊所的数量和患者焦虑，因为将消除组织病理学诊断的长期等待。因此，该技术有可能增加对无法进行筛查的后续访问量的人群的机会。该技术对患者没有已知的风险，因此可能是当前筛查方法的安全替代风险。 公共卫生相关性：近年来，皮肤癌的发病率一直在增加，与大多数癌症一样，早期诊断和彻底治疗（即完全切除）是获得良好预后的关键。当前针对皮肤癌的诊断方法依赖于身体检查以及皮肤活检的结合，这些方法的早期诊断精度有限。因此，人们对开发非侵入性诊断和筛查工具有很大的兴趣，该工具可以在早期阶段准确识别皮肤癌。这样的工具不仅可以检测到早期的恶性肿瘤迹象，还可以减少不必要的诊断手术程序，从而通过准确描述手术前和手术过程中的皮肤癌边缘来促进皮肤癌的完全切除，并允许对患者进行治疗的患者进行监测。最初的报告已经使用成像或光谱法确定了非侵入性光学设备的实际局限性，以评估正常皮肤，良性病变和恶性肿瘤的各种临床外观。在此提案中，我们描述了一种专门针对皮肤的基础微观结构和生化组成的设备的设计。皮肤和皮肤癌的变异性提出的挑战为拟议的多模式装置提供了理想的测试器官和病理。该R21提案旨在验证以下假设：将形态成像与光学相干断层扫描（OCT）和黑色光谱学（RS）结合使用的设备增加了医生可用的诊断信息，并且可以单独提高每种技术的诊断性能。该项目的可行性阶段旨在开发合并的RSOCT系统，并验证这种合并的成像方法以检测皮肤癌。该特定目的旨在旨在可量化和可实现的里程碑，这将证明这种癌症诊断方法的潜力，尤其是皮肤癌检测。特定目标＃1：开发和测试台式台式组合的RS-OCT系统：将在傅立叶域-OCT光谱雷达系统的平台上开发组合系统的台式版本，该系统由两个源，但单个检测器和样品组组成。 OCT和RS的性能将与现有体内系统的基准值进行比较。特定目的＃2：为体内应用开发RSOCT手持式探针：为了测试体内多模式系统的实用性，将开发手持式探针，并且整个系统都可以便携，以允许从难以到达病变地点进行测量的灵活性。 OCT和RS的性能将与台式系统的基准值进行比较。具体目的＃3：对30例可疑基底细胞癌（BCC）患者进行试验研究，以证明效用RS-OCT：一项小型试点研究将评估合并装置在临床实践中的合并设备的有效性，在该临床实践中，涉嫌BCC的病变将单独使用RS，单独使用RS，OCT和RS-RS-OCT评估。 RS区分正常良性病变和恶性病变的能力将与OCT引导Rs进行比较。上述具体目的将证明RSOCT对皮肤癌的诊断和可能筛查的潜力。拟议的工作将通过使用单个检测工具提供完全疾病管理的潜力，对医疗保健产生重大影响。这将改善患者护理和成本效益。随着该技术的成功，RSOCT可以应用于其他器官部位，例如乳房，前列腺和卵巢以及其他疾病，从而影响医学领域的广泛领域。