hANDY-i(TM): A non-invasive, dual-sensor handheld imager for intraoperative preservation of parathyroid glands

hANDY-i(TM)：一种非侵入性双传感器手持式成像仪，用于术中保存甲状旁腺

• 批准号: 10545988
• 负责人: Richard Jaepyeong Cha
• 金额: $ 74.98万
• 依托单位: OPTOSURGICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10545988
• 关键词: Accidental Injury; Allergic Reaction; Angiography; Appearance; Attention; Blood Vessels; Brown Fat; Calcium; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Color; Communities; Complement; Complication; Data Set; Decision Making; Detection; Development; Devices; Diagnosis; Dissection; Dyes; Economic Burden; Endocrine; Equipment; Evaluation; Excision; Fatty acid glycerol esters; Feedback; Fluorescence Angiography; Fluorescent Dyes; Freezing; Funding; Gland; Goals; Grant; Head and Neck Surgery; Hospital Departments; Hospitals; Hypocalcemia; Hypoparathyroidism; Image; Imaging Device; Imaging technology; Indocyanine Green; Injections; Joints; Lead; Length of Stay; Light; Monitor; Morbidity - disease rate; Neck; Nerve; Operating Rooms; Operative Surgical Procedures; Optics; Otolaryngology; Outcome; Parathyroid gland; Patients; Performance; Perfusion; Persons; Phase; Plasma; Play; Positioning Attribute; Postoperative Period; Procedures; Regulatory Pathway; Research; Research Personnel; Resected; Risk; Scientist; Serum; Signal Transduction; Small Business Innovation Research Grant; Software Engineering; Standardization; Sterility; Stream; Surgeon; System; Techniques; Technology; Thyroid Diseases; Thyroid Gland; Thyroid Gland Tissue; Thyroidectomy; Time; Tissue Viability; Tissues; Translating; Translations; United States National Institutes of Health; Vascular blood supply; Vascularization; Veterans; Visual; cost efficient; design; digital imaging; feasibility testing; feeding; imager; imaging platform; improved; improved outcome; lymph nodes; meetings; operation; portability; preservation; prevent; prototype; sensor; sensor technology; socioeconomics; thyroid neoplasm; tool; translational study; tumor; usability

Abstract Post-surgical hypoparathyroidism or hypocalcemia are known to occur frequently after thyroid surgeries due to the misidentification and/or accidental removal of healthy parathyroid glands. Approximately 150,000 thyroidectomies are performed in the US, 27% of these patients suffer from transient or permanent hypocalcemia, which can lead to lifelong sequelae and socioeconomic burden. Because of the small size, the variable position, and the similar appearance to the surrounding tissues such as lymph node, fat, and thyroid gland, it is often difficult for low volume surgeons to distinguish parathyroid glands from thyroid tissue. Furthermore, blood supply to parathyroid glands is fragile and can be damaged easily during dissection. This is a challenging problem because it is clinically hard to tell by visual inspection if a gland is still viable after manipulation. There are currently no standardized or practical equipment available to localize and assess viability of parathyroid glands in real time and in a non-invasive manner during operation. Thus, any viable solution would be considered as significant to the endocrine community. In this research, we propose to develop a non-invasive, handheld imager that will potentially be a paradigm changing tool for patients with thyroid tumors. Our imaging solution, called hANDY-iTM, will permit 1) a non-invasive parathyroid gland identification and 2) seamless display of tissue viability in real-time for the preservation of the parathyroid glands during thyroid surgery. This research will be a joint effort combining the technical and clinical expertise of Optosurgical, LLC and Johns Hopkins Hospital. To validate our hypothesis, we will study the following specific aims; Aim1: Clinically viable prototype development; Aim 2: Clinical trials to validate the proposed system (N=64); Aim3: Premarket device evaluation. We envision that our technology will open a new door for the digital imaging paradigm of dye-free, temporally unlimited, and precise parathyroid detection and preservation. Successful translation of this technology will potentially reduce the risk of hypoparathyroidism during thyroid surgery and improve the clinical outcomes.

摘要 众所周知，手术后甲状旁腺功能减退或低钙血症在甲状腺手术后经常发生。 由于误诊和/或意外切除健康的甲状旁腺。大致 美国进行了15万例甲状腺切除术，其中27%的患者患有一过性或 永久性低钙血症，可导致终生后遗症和社会经济负担。因为. 体积小，位置可变，外观与周围组织相似，如 低容量外科医生往往很难区分甲状旁腺、淋巴结、脂肪和甲状腺 甲状腺组织中的腺体。此外，甲状旁腺的血液供应是脆弱的， 在解剖过程中容易损坏。这是一个具有挑战性的问题，因为临床上很难判断 目视检查腺体在操作后是否仍然存活。目前还没有标准化的或 可用于实时定位和评估甲状旁腺生存能力的实用设备 术中非侵入性方式。因此，任何可行的解决方案都将被视为对 内分泌界。 在这项研究中，我们建议开发一种非侵入性的手持成像器，这将是一种潜在的 甲状腺肿瘤患者的范式改变工具。我们的成像解决方案，称为Handy-ITM，将 允许1)非侵入性甲状旁腺鉴定和2)组织活性的无缝显示 在甲状腺手术中实时保留甲状旁腺。这项研究将是一项 将OptosSurgical、LLC和Johns Hopkins的技术和临床专业知识结合起来的联合努力 医院。为了验证我们的假设，我们将研究以下具体目标；目标1：临床可行 原型开发；目标2：验证建议系统的临床试验(N=)；目标3： 上市前设备评估。 我们设想，我们的技术将为数字成像范式打开一扇新的大门， 时间上不受限制，精确的甲状旁腺检测和保存。这篇文章的成功翻译 技术将潜在地降低甲状腺手术中甲状旁腺功能低下的风险，并改善 临床结果。