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

项目总结 这项提议是基于范德比尔特大学和Anasys之间的学术-产业合作伙伴关系 寻求成功地将内分泌癌手术中的新成像能力带给 最终用户-外科医生，用于术中甲状旁腺的识别。在此，我们建议 发展近红外光学成像，以实时显示颈部相关结构 在内分泌手术中--一种没有谓词的应用和技术 甲状腺和甲状旁腺疾病依靠手术来确定治疗方法。在这100,000多个手术中 在美国，甲状旁腺每年进行一次手术，很难与甲状腺和周围组织区分开来 颈部的组织，因为它的体积小，位置多变。甲状旁腺功能不全时会出现并发症 在甲状腺切除手术中意外受伤或切除，或在以下情况下仅部分切除 甲状旁腺切除术。前者可出现甲状旁腺功能低下和低钙血症，导致严重的长时间 期限效应。据报道，低钙血症的发生率发生在甲状腺全切除术中的9-21%。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，有一个 迫切需要一种灵敏的工具，可以在术中识别甲状旁腺，而不考虑疾病 州政府。 范德比尔特和Anasys联合提出近红外自发荧光的临床翻译改进 内分泌癌手术的患者结局。科学的创新之处在于光学技术的应用。 一种外科手术指导技术，不侧重于疾病检测，而是侧重于对 生理器官与疾病状态无关，准确率接近100%。近红外技术 荧光(特别是在这里提出的波长范围内)从未被商业化实施。 使用天然生物荧光团作为造影剂。此外，将荧光成像与激光相结合 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。 拟议项目的具体目标如下：(1)验证组织中的荧光 颈部内分泌手术(2)评价观察到的近红外荧光的基础。(3)发展 将荧光散斑成像系统与激光散斑成像系统结合应用于临床。(4)验证 近红外荧光性能的前瞻性研究。这些目标一旦实现，将产生两个准备就绪的系统 对于商业翻译，可以提供实时光学反馈，以减少多头和空头的可能性 与意外或不完全摘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.