Academic-Industry Partnership for the Translation of a Novel Optical Imaging Approach to guide Endocrine Cancer Surgery

项目摘要 该提案基于范德比尔特大学和Anasys之间的学术-工业合作伙伴关系 Instruments Inc.该研究旨在成功地将内分泌癌手术中的新成像能力带到 最终用户-外科医生，用于甲状旁腺的术中识别。在此，我们建议 开发近红外光学成像，用于颈部相关结构的真实的时间可视化 在内分泌手术期间-一种无实质等同器械的应用和技术 甲状腺和甲状旁腺疾病依赖于手术进行明确的治疗。在这超过10万例手术中 在美国，甲状旁腺很难与甲状腺及其周围组织区分开来。 由于其尺寸小且位置可变，因此颈部的组织中存在大量的脂肪。并发症发生在甲状旁腺 在甲状腺切除术期间意外受伤或切除，或在以下情况下仅部分切除 甲状旁腺切除前者可发生甲状旁腺功能减退和低钙血症，导致严重的长 长期影响。据报道，低钙血症的发生率发生在9-21%的甲状腺切除术。事实上， 低钙血症是内分泌手术后医疗事故诉讼的最常见原因。因此有 迫切需要一种灵敏的工具，可以识别术中甲状旁腺，无论疾病 状态 范德比尔特和Anasys联合提出近红外自体荧光的临床翻译，以提高 内分泌癌手术的患者结局。科学创新是在应用光学 一种外科手术引导技术，其重点不是疾病检测，而是解剖学识别。 无论其疾病状态如何，其生理器官都具有接近100%的准确性。近红外技术 荧光（特别是在这里提出的波长范围内）从未在商业上实现 使用天然生物荧光团作为造影剂。此外，将荧光成像与激光 组织覆盖散斑成像用于甲状旁腺解剖和功能的实时评估 gland增加了这项工作的创新性。 本项目的具体目标如下：（1）研究组织中的荧光， （2）评价观察到的近红外荧光的基础。(3)开发一个 用于临床实施的组合荧光和激光散斑成像系统。(4)验证 近红外荧光性能的前瞻性。这些目标一旦实现，将产生两个系统 对于商业翻译，可以提供实时的光学反馈，以减少长和短的可能性， 与意外或不完全切除甲状旁腺组织相关的长期副作用。

PROJECT SUMMARY This proposal is based on an Academic-Industrial partnership between Vanderbilt University and Anasys Instruments Inc. that seeks to successfully bring a new imaging capability in endocrine cancer surgery to the end-user– the surgeon, for the intraoperative identification of the parathyroid gland. Here we propose to develop optical imaging in the near infrared for the real time visualization of relevant structures in the neck during endocrine surgery – an application and a technology that has no predicate Thyroid and parathyroid diseases rely on surgery for definitive treatment. In these over 100,000 surgeries performed each year in the US, parathyroid glands are difficult to distinguish from the thyroid and surrounding tissues in the neck, due to its small size and variability in position. Complications occur when the parathyroid is accidentally injured or removed during thyroidectomies or only partially removed in the case of parathyroidectomies. In the former, hypoparathyroidsim and hypocalcemia can occur, resulting in serious long term effects. The incidence of hypocalcemia is reported to occur in 9-21% of total thyroidectomies. In fact, hypocalcemia is the most common cause of malpractice litigation after endocrine surgery. Therefore, there is a critical need for a sensitive tool that can identify the parathyroid glands intraoperatively, regardless of disease state. Vanderbilt and Anasys jointly propose the clinical translation of near infrared autofluorescence to improve patient outcome in endocrine cancer surgeries. The scientific innovation is in the application of an optical technique for surgical guidance that is not focused on disease detection but on anatomical identification of a physiological organ regardless of its disease state with near 100% accuracy. The technique of near infrared fluorescence (particularly in the wavelength range proposed here) has never been commercially implemented using natural biological fluorophores as the contrast agent. Further, combining fluorescence imaging with laser speckle imaging with tissue overlay for real-time assessment of the anatomy and function of the parathyroid gland adds to the innovation of this work. The specific aims of the proposed project are as follows: (1) Validate the fluorescence of tissues in the neck during endocrine surgery (2) Evaluate the basis of the observed NIR fluorescence. (3) Develop a combined fluorescence and laser speckle imaging system for clinical implementation. (4) Validate the performance of NIR fluorescence prospectively. These objectives, when achieved, will yield two systems ready for commercial translation that can provide real-time optical feedback to reduce the likelihood of long and short term side effects associated with accidental or incomplete removal of parathyroid tissue.