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: 10706615
• 负责人: Richard Jaepyeong Cha
• 金额: $ 96.6万
• 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/10706615
• 关键词: Accidental Injury; Accidents; 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; Hospitals; Hypocalcemia; Hypoparathyroidism; Image; Imaging Device; Imaging technology; Indocyanine Green; Injections; Joints; Length of Stay; Light; Marketing; 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; Reporting; Research; Research Personnel; Resected; Risk; Risk Reduction; 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; Visualization; cost efficient; design; digital imaging; ergonomics; 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.

抽象的 已知甲状腺手术后经常发生术后甲状旁腺功能减退症或低钙血症 由于错误识别和/或意外切除健康的甲状旁腺。大约 美国进行了 150,000 例甲状腺切除术，其中 27% 的患者患有短暂性或 永久性低钙血症，可能导致终生后遗症和社会经济负担。由于 尺寸小、位置可变、外观与周围组织相似，例如 淋巴结、脂肪和甲状腺，小体积外科医生通常很难区分甲状旁腺 来自甲状腺组织的腺体。此外，甲状旁腺的血液供应很脆弱，可能会受到影响。 解剖时容易损坏。这是一个具有挑战性的问题，因为临床上很难通过 目视检查腺体在操作后是否仍然存活。目前还没有标准化或 可用于实时定位和评估甲状旁腺活力的实用设备 手术过程中以非侵入方式进行。因此，任何可行的解决方案都将被认为对 内分泌界。 在这项研究中，我们建议开发一种非侵入式手持成像仪，它有可能成为 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) 非侵入性甲状旁腺识别和 2) 无缝显示组织活力 在甲状腺手术期间实时保存甲状旁腺。这项研究将是 Optosurgical, LLC 和约翰·霍普金斯大学的技术和临床专业知识相结合的共同努力 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：验证所提出系统的临床试验（N=64）；目标3： 上市前设备评估。 我们设想我们的技术将为无染料、 时间不受限制且精确的甲状旁腺检测和保存。这篇翻译成功 该技术将有可能降低甲状腺手术期间发生甲状旁腺功能减退症的风险，并改善 临床结果。

项目成果

Pediatric Brain Tissue Segmentation Using a Snapshot Hyperspectral Imaging (sHSI) Camera and Machine Learning Classifier.

使用快照高光谱成像 (sHSI) 相机和机器学习分类器进行儿科脑组织分割。

• 发表时间: 2023-10-13
• 作者: Kifle, Naomi;Teti, Saige;Ning, Bo;Donoho, Daniel A;Katz, Itai;Keating, Robert;Cha, Richard Jaepyeong
• 通讯作者: Cha, Richard Jaepyeong

A pilot feasibility study to assess vascularity and perfusion of parathyroid glands using a portable hand-held imager.

使用便携式手持式成像仪评估甲状旁腺的血管分布和灌注的试点可行性研究。

• 发表时间: 2022-03
• 影响因子: 2.4
• 作者: Oh, Eugene;Lee, Hun Chan;Kim, Yoseph;Ning, Bo;Lee, Seung Yup;Cha, Jaepyeong;Kim, Wan Wook
• 通讯作者: Kim, Wan Wook

Parathyroid gland detection using an intraoperative autofluorescence handheld imager - early feasibility study.

使用术中自发荧光手持成像仪检测甲状旁腺 - 早期可行性研究。

• 发表时间: 2023
• 作者: Ali, Khalid Mohamed;Wolfe, Samantha A;Nagururu, Nimesh V;Seo, Stefanie;Han, Sung;Kim, Yoseph;Oh, Eugene;Kim, Dong;Ning, Bo;Lee, Seung Yup;Cha, Richard Jaepyeong;Tufano, Ralph P;Russell, Jonathon O
• 通讯作者: Russell, Jonathon O

TOETVA parathyroid autofluorescence detection: hANDY-i endoscopy attachment.

TOETVA 甲状旁腺自发荧光检测：hANDY-i 内窥镜附件。

• 发表时间: 2023
• 作者: Seo, Stefanie;Ali, Khalid Mohamed;Wolfe, Samantha A;Nagururu, Nimesh V;Ding, Andy S;Desai, Dipan;Harbison, R Ale;Kim, Yoseph;Ning, Bo;Cha, Richard Jaepyeong;Russell, Jonathon O
• 通讯作者: Russell, Jonathon O