Multimodal Optical Probe for Skin Cancer Detection and Therapy Guidance

项目概要/摘要 本研究项目的主要目标是开发一种新型的光学成像技术，并将其转化为临床应用。 基于光学相干断层扫描（OCT）和共焦显微镜（CM）的非成像技术 非黑色素瘤皮肤癌（NMSC）的侵入性实时诊断、肿瘤亚型和边缘定位 这将有助于医生-患者在治疗计划中做出决定（活检与不活检，手术与非手术）， 以及进行治疗。 皮肤癌发病率和患病率的增加，特别是在老龄化人口中， 手术和随后的重建费用高昂， 患者忍受手术干预，导致越来越多地采用和实施替代治疗， 非手术治疗，可以是非常有效的和侵入性较小。激光消融术和放射疗法 已被证明是有效的治疗常见的皮肤癌，并有额外的好处， 可耐受且与较少疤痕或毁容无关。因此，它们的临床应用 近年来，用于治疗皮肤癌的药物越来越多。然而，在提供有效服务方面的主要挑战是， 皮肤癌的激光能量密度或放射治疗剂量是准确描绘癌症靶点的深度， 和横向。幸运的是，OCT/CM在微米尺度上可视化组织形态的独特能力 分辨率可以在临床中实时使用，以帮助治疗目标描绘， 在不需要“估计”亚临床扩散程度的情况下递送治疗，从而最小化副作用。 此外，CM/OCT可用于确认皮肤癌的根除，目前仅限于视觉检查。 检查是一种高度不敏感和主观的方法。 将对这项技术协助准确划定目标的可行性进行初步评估， 在第一阶段计划中。根据第一阶段的结论，该技术将在 II期，并在大量患者人群中进行临床评价。治疗决策辅助和治疗 将评估制导能力。

Project Summary/Abstract The primary goal of this research project is to develop and translate to clinical use a novel optical imaging technology based on combined Optical Coherence Tomography (OCT) and Confocal Microscopy (CM) for non- invasive real-time diagnosis of non-melanoma skin cancers (NMSCs), tumor subtyping and margin mapping that will assist physician-patient decision in treatment planning (biopsy vs. no biopsy, surgery vs. non-surgical), as well as on performing the therapy. The increasing incidence and prevalence in skin cancer, especially among the aging population, combined with the high costs of surgery and subsequent reconstruction, and the physical and psychological trauma that patient endures with surgical intervention, has led to an increasing adoption and implementation of alternative non-surgical treatments that can be highly effective and less invasive. Laser ablation and radiotherapy have been proven to be effective therapies for common skin cancers and have the additional benefits that are easily tolerable and not associated with less scarring or disfigurement. Therefore, their clinical use has substantially increased within the recent years to treat skin cancers. However, the primary challenge in delivering effective laser fluence or radiotherapy dose for skin cancer is accurate delineation of the cancer target, both in depth and laterally. Fortunately, the unique capability of OCT/CM to visualize tissue morphology with micron-scale resolution can be used in real-time in the clinics to aid therapy target delineation and enable more precise delivery of therapy without need to “estimate” the subclinical extent of spread, thereby minimizing side effects. In addition, CM/OCT can be used to confirm eradication of skin cancer, which is currently limited to visual inspection, a highly insensitive and subjective method. The preliminary evaluation of the feasibility of this technology for aiding accurate target delineation will be performed during the Phase I program. Based on Phase I conclusions, the technology will be refined in Phase II and evaluated clinically on a large pool of patient population. Both therapy decision aiding and therapy guidance capabilities will be evaluated.