Two photon fluorescence microscopy for dermatologic surgery and biopsy

用于皮肤手术和活检的双光子荧光显微镜

• 批准号: 10600137
• 负责人: Michael Gene Giacomelli
• 金额: $ 33.56万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10600137
• 关键词: Acceleration; Address; Anesthesia procedures; Basal cell carcinoma; Biopsy; Biopsy Specimen; Cancer Patient; Caring; Clinic; Clinic Visits; Clinical; Clinical Research; Clinical Trials; Collaborations; Conduct Clinical Trials; Consent; Consumption; Conventional Surgery; Dermatologic; Dermatology; Detection; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Dyes; Evaluation; Excision; Fiber; Fluorescence Microscopy; Frozen Sections; Goals; Health Care Costs; Health Services Accessibility; Healthcare Systems; Histologic; Histology; Histopathology; Image; Image-Guided Surgery; Imaging technology; Individual; Label; Lasers; Malignant Neoplasms; Medicare; Methods; Microtomy; Mohs Surgery; Molecular; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Paraffin; Patient Schedules; Patients; Photons; Postoperative Period; Prevalence; Procedures; Process; Protocols documentation; Recurrence; Recurrent tumor; Research; Resources; Risk; Sensitivity and Specificity; Silicon; Skin Cancer; Skin Carcinoma; Slide; Source; Speed; Squamous cell carcinoma; Stains; Surgical Management; Surgical Pathology; Surgical margins; System; Technology; Testing; Time; Tissues; Treatment Cost; Variant; Visit; cancer surgery; cancer type; common treatment; contrast enhanced; cost; cost effective; detector; experience; high risk; histological image; human tissue; image guided; improved; instrument; microscopic imaging; miniaturize; multidisciplinary; new technology; photomultiplier; programs; recruit; rural area; standard of care; surgical risk; tool; tumor; two-photon

Medicare reimburses over 5 million biopsies resulting in 1.5 million surgical procedures annually for nonmelanoma skin cancer (NMSC). Despite its burden on the health care system, treatment remains time- consuming and unevenly available due to inefficient histologic methods used for diagnosis and to guide therapy. As an alternative, two photon fluorescence microscopy (TPFM) combined with rapid molecular labeling can evaluate histology dramatically faster than conventional methods. We have developed high speed TPFM imaging for dermatologic surgery, protocols for rapid molecular labeling of human tissue, and conducted preliminary studies showing that TPFM can evaluate skin cancer with similar accuracy to conventional histology. Our approach addresses the limitations of current methods, which begin with diagnosis, where the delay for histology means that patients must return for a second clinic visit if biopsies are positive. Inefficiencies are compounded during therapy, where in standard excision the delay for processing means that histology is evaluated postoperatively, and a second surgery may be required to complete therapy. Alternatively, in Mohs surgery, intraoperative frozen sections may be used, resulting in a substantial increase in procedure time and reduced clinic capacity. As a result, costs are increased and access to care is subject to regional variations, with patients in rural areas more likely to receive substandard care that puts them at risk for disfigurement or tumor recurrence. The goal of this research program is to advance two photon imaging technology for surgical applications, and then conduct clinical trials testing the use of TPFM in both diagnostic biopsy procedures and in surgical treatment of NMSC. The aims for this proposal are: Aim 1 will develop improved TPFM that incorporates recent advances in detector and laser technology to reduce cost, shrink size, and enhance contrast, providing an efficient new tool for diagnosing and treating NMSC. Concurrently, studies will examine the accuracy of TPFM for a less common type of skin cancer. Aim 2 will study patients undergoing dermatologic biopsy, testing the hypothesis that patients can be immediately diagnosed using TPFM, enabling same visit treatment for common skin cancers. Finally, Aim 3 proposes interventional surgical trials. Aim 3, Task 1 will integrate TPFM into Mohs surgery, testing the hypothesis that faster histological imaging can accelerate treatment. Aim 3, Task 2 will introduce TPFM for margin evaluation into standard (non-Mohs) excision of skin cancer, testing the hypothesis that TPFM can be used in a scenario for which no intraoperative imaging is currently practical. Collectively, these aims will test more efficient methods of diagnosing and excising skin cancer, accelerating treatment, reducing costs and morbidity while expanding access to care. Successful completion of this project would demonstrate powerful new tools for general surgical pathology and validate them for use in dermatologic surgery.

医疗保险每年报销超过 500 万次活检，导致 150 万例外科手术 非黑色素瘤皮肤癌（NMSC）。尽管给医疗保健系统带来了负担，但治疗仍然需要时间 由于用于诊断和指导治疗的组织学方法效率低下，导致资源消耗和利用不均。 作为替代方案，双光子荧光显微镜 (TPFM) 与快速分子标记相结合 可以比传统方法更快地评估组织学。我们开发了高速TPFM 皮肤科手术成像、人体组织快速分子标记方案，并进行 初步研究表明 TPFM 可以以与传统方法相似的准确度评估皮肤癌 组织学。我们的方法解决了当前方法的局限性，从诊断开始，其中 组织学检查的延迟意味着如果活检呈阳性，患者必须返回进行第二次就诊。效率低下 在治疗期间复合，在标准切除中，处理的延迟意味着组织学是 术后评估，可能需要第二次手术才能完成治疗。或者，在莫氏 手术时，可能会使用术中冰冻切片，导致手术时间大幅增加， 诊所容量减少。因此，成本增加，获得护理的机会也因地区差异而异， 农村地区的患者更有可能接受不合格的护理，这使他们面临毁容或肿瘤的风险 复发。该研究计划的目标是推进外科手术的双光子成像技术 应用程序，然后进行临床试验测试 TPFM 在诊断性活检中的使用 NMSC 的手术和手术治疗。该提案的目标是： 目标 1 将开发改进的 TPFM 结合了探测器和激光技术的最新进展，以降低成本、缩小尺寸和 增强对比度，为诊断和治疗 NMSC 提供有效的新工具。同时，研究将 检查 TPFM 对不太常见的皮肤癌类型的准确性。目标 2 将研究接受治疗的患者 皮肤活检，检验患者可以使用 TPFM 立即诊断的假设，使 常见皮肤癌的同次就诊治疗。最后，目标 3 提出介入手术试验。目标 3、任务 1 将把 TPFM 整合到莫氏手术中，检验更快的组织学成像可以加速的假设 治疗。目标 3、任务 2 将在标准（非莫氏）皮肤切除中引入用于边缘评估的 TPFM 癌症，检验 TPFM 可用于无需术中成像的情况的假设 目前实用。总的来说，这些目标将测试更有效的皮肤诊断和切除方法 癌症，加速治疗，降低费用和发病率，同时扩大获得护理的机会。成功的 该项目的完成将展示普通外科病理学的强大新工具并验证 它们用于皮肤外科手术。