New approach for an optical biopsy in melanoma diagnostics

光学活检诊断黑色素瘤的新方法

• 批准号: 432242402
• 负责人: Professor Dr. Steffen Emmert
• 金额: --
• 依托单位: Hannoversches Zentrum für Optische Technologien (HOT)
• 依托单位国家: 德国
• 项目类别: New Instrumentation for Research
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/432242402?language=en
• 关键词: New; approach; optical; biopsy; melanoma

Malignant melanoma is the most dangerous type of skin cancer and has the highest mortality rate. Since the 1980s, the incidence rate has more than tripled. This project addresses an existing deficit in melanoma diagnostics. For a suspicious skin lesion it is often not clear whether it is malignant or benign. The tumor thickness, i.e. the depth of invasion of melanoma cells, is the decisive criterion apart from the dignity (malignant or benign) for assessing the tumor stage and the prognosis of the disease. It also determines the further treatment. According to the current gold standard, a reliable diagnosis of melanoma and the determination of the actual thickness are only possible by histopathology. Reliable, timely and non-invasive diagnostics are currently not possible, but would signify a clear improvement and initiate a paradigm shift in melanoma diagnostics.The overall goal of this project is the development of a new, integrative device that will enable the determination of both (i) the invasion depth and (ii) the dignity of suspected melanoma skin lesions preoperatively, for the first time, leading to reliable diagnosis. To obtain all relevant information, three optical modalities - optical coherence tomography (OCT), optoacoustics (OA) and Raman spectroscopy (RS) - will be combined for the first time in a multimodal device, the accessible skin parameters explored and their diagnostic capability evaluated. Also, the associated intelligent, au-tomated evaluation procedures will be established and the functionality validated in mouse and patient measurements in the clinic.The challenges of the project are (i) the realization of a fast (< 15 min) imaging system through combination of the three modalities, (ii) the reliable determination of the invasion depth of lesions using OCT and OA (up to 1.5 mm with OCT and several mm with OA) with similar resolution (<15 μm and <30 μm, resp.), (iii) the determination of lesion dignity by OCT (morphology) and RS (chemical composition) with high sensitivity (> 90%) and specificity (> 70%), and (iv) the implemen-tation of evaluation algorithms relying on generated data bases that will enable faithful and rapid lesion determination by multivariate data analysis, 3D segmentation, and deep learning algorithms.At the end of the proposed 3 year funding period, the suitability of the new device with regard to determination of invasion depth and dignity of melanoma will be demonstrated and validated. The multimodal system should ensure, for the first time, an optical biopsy in melanoma diagnosis with high sensitivity and specificity. In a potential second 2-year funding period, the suitability of the device shall be evaluated in a clinical pilot study. Also the potential with regard to identification of diagnostic criteria for other skin diseases, i.e. inflammatory skin diseases and different skin cancer types, as well as disease progression and melanoma therapy studies can be investigated.

恶性黑色素瘤是最危险的皮肤癌类型，死亡率最高。自20世纪80年代以来，发病率增加了两倍多。该项目解决了黑色素瘤诊断的现有缺陷。对于可疑的皮肤病变，通常不清楚是恶性还是良性。肿瘤厚度，即黑色素瘤细胞的侵入深度，是除了尊严（恶性或良性）之外的用于评估肿瘤阶段和疾病预后的决定性标准。它也决定了进一步的治疗。根据目前的黄金标准，黑色素瘤的可靠诊断和实际厚度的确定只能通过组织病理学。可靠，及时和非侵入性的诊断目前是不可能的，但这将意味着一个明显的改善，并开始在黑色素瘤diagnosis.The总体目标是一个新的，综合设备的发展，将能够确定（i）入侵深度和（ii）可疑的黑色素瘤皮肤病变术前的尊严，第一次，导致可靠的诊断。为了获得所有相关信息，三种光学模式-光学相干断层扫描（OCT），光声（OA）和拉曼光谱（RS）-将首次在多模态设备中结合，探索可访问的皮肤参数并评估其诊断能力。此外，还将建立相关的智能、自动化评估程序，并在临床中对小鼠和患者的测量进行功能验证。（< 15分钟）成像系统，通过三种模式的组合，（ii）使用OCT和OA以相似的分辨率（分别<15 μm和<30 μm）可靠地确定病变的侵入深度（OCT高达1.5 mm，OA高达几mm），(iii)OCT对病变程度的判断（形态学）和RS（化学成分）具有高灵敏度（> 90%）和特异性（> 70%），以及（iv）依赖于生成的数据库的评估算法的实施，这将通过多变量数据分析，3D分割和深度学习算法实现忠实和快速的病变确定。在拟议的3年资助期结束时，将证明和验证新装置在确定黑色素瘤浸润深度和尊严方面的适用性。多模式系统应确保，第一次，在黑色素瘤诊断的光学活检具有高灵敏度和特异性。在潜在的第二个2年资助期内，应在临床试点研究中评价器械的适用性。还可以研究关于鉴定其他皮肤病的诊断标准的潜力，即炎性皮肤病和不同的皮肤癌类型，以及疾病进展和黑色素瘤治疗研究。