Endoscope development for the clinical use of near infrared fluorescence molecular probes in the GI tract

近红外荧光分子探针在胃肠道临床应用的内窥镜开发

• 批准号: 10493360
• 负责人: Gerald McMorrow
• 金额: $ 100.22万
• 依托单位: VERAVANTI, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10493360
• 关键词: Academic support; Algorithms; Architecture; Barrett Esophagus; Binding; Biological; Biopsy; Caliber; Classification; Clinical; Clinical Research; Clinical Trials; Collaborations; Color; Computer Assisted; Computer software; Development; Device or Instrument Development; Devices; Diagnosis; ERBB2 gene; Early Diagnosis; Endoscopes; Endoscopy; Engineering; Epidermal Growth Factor Receptor; Epithelial Cells; Esophageal Adenocarcinoma; Esophagus; Evaluation; Excision; Eye; Fiber; Fluorescence; Forcep; Future; Gastroenterologist; Gastrointestinal tract structure; Goals; Grant; High grade dysplasia; Hour; Image; Image Analysis; Imaging Device; Intervention; Label; Lasers; Lead; Lesion; Letters; Licensing; Light; Localized Lesion; Malignant Neoplasms; Malignant neoplasm of esophagus; Malignant neoplasm of gastrointestinal tract; Measurement; Medical; Medical Imaging; Medical Technology; Methods; Michigan; Molecular; Molecular Probes; Multi-Institutional Clinical Trial; Multimodal Imaging; Near-infrared optical imaging; Oncoproteins; Peptides; Performance; Phase; Physicians; Positioning Attribute; Precancerous Conditions; Production; Receptor Protein-Tyrosine Kinases; Records; Research; Sampling; Scanning; Sedation procedure; Small Business Innovation Research Grant; Specificity; Structure; Survival Rate; System; Techniques; Technology; Testing; Time; Tissues; Translating; Universities; Update; Visualization; Washington; Work; algorithm development; base; cancer cell; cancer diagnosis; cancer imaging; cell growth; clinical development; contrast enhanced; cost; deep learning; design; diagnostic algorithm; flexibility; fluorescence imaging; high risk; image guided; image processing; imaging system; improved; instrument; minimally invasive; molecular marker; mortality; multimodality; neoplastic; neoplastic cell; novel; optical imaging; overexpression; premalignant; prototype; research clinical testing; spectral distortion; standard of care; tool; usability

Minimally-invasive optical imaging is being advanced by molecular probes that enhance contrast using fluorescence. The applications in cancer imaging are very broad, ranging from early diagnosis of cancer to the guiding of interventions, such as biopsy. The high-sensitivity afforded by wide-field fluorescence imaging using scanning laser light is being developed for these broad applications. The platform technology is the SFE – Scanning Fiber Endoscope, which places a sub-1-mm scanner at the tip of a highly flexible shaft. Because several different laser wavelengths can be mixed and scanned together, full-color reflectance imaging will be combined with near infrared (NIR) fluorescence imaging in a 4-channel multimodal SFE. The goal of this project is to develop a prototype VerAvanti 4-channel multimodal SFE (mmSFE) for a specific cancer imaging application that can have significant impact in early detection and endoscopic treatment of esophageal cancer. VerAvanti is a start-up company located in Redmond, Washington and is founded and staffed with engineering graduates from the University of Washington (UW), where the SFE was invented and tested in pilot clinical trials. VerAvanti has exclusive license to commercialize the SFE technology for medical imaging and a 3- channel full color SFE (using red, green, and blue reflectance) is already in pilot manufacturing and testing. This project will rapidly translate the 4-channel mmSFE technology into a specific product for fluorescently guiding endoscopic interventions in the GI tract. Furthermore, the VerAvanti mmSFE will be designed for efficient manufacturing in a modular format with reduced part numbers and expected lower cost. The application is using NIR fluorescence molecular probes that were developed at the University of Michigan (UM) that bind to high grade dysplasia (HGD) and neoplastic cells of esophageal adenocarcinoma (EAC). The mmSFE product is introduced through the working channel of a conventional endoscope to identify regions of the lower esophagus that are over-expressing EGFR and ErbB2, which are transmembrane tyrosine kinase receptors that stimulate epithelial cell growth, proliferation, and differentiation. Overexpression of these targets reflects an increase in biological aggressiveness and higher risk for progression to Barrett's esophagus, HGD, and EAC. The design of the mmSFE diagnostic algorithm is based on the high correlation of the fluorescence lesion target-to-background measurement in collaboration with UW and UM. Additional mmSFE guided tools will be developed for more accurate endoscopic interventions using NIR fluorescence molecular probes. Both software and hardware will be fabricated and tested for the start of a multisite clinical trial using the mmSFE.

通过分子问题提出了最小侵入性光学成像，从而增强对比度的分子问题 荧光。癌症成像中的应用非常广泛，从早期诊断到癌症到 指导干预措施，例如活检。使用宽场荧光成像提供的高敏性 为这些广泛的应用开发了扫描激光光。平台技术是SFE - 扫描纤维内窥镜，该纤维内窥镜将低于1毫米的扫描仪放在高度柔韧的轴的尖端。因为 可以将几种不同的激光波长混合在一起并扫描在一起，全彩反射率成像将是 与4通道多模式SFE中的近红外（NIR）荧光成像结合。目标的目标 项目是为特定的癌症成像开发原型Veravanti 4通道多模式SFE（MMSFE） 可以在早期检测和内窥镜治疗食管癌中产生重大影响的应用。 Veravanti是一家位于华盛顿雷德蒙德的初创公司，成立并配备了工程 华盛顿大学（UW）的毕业生，在该公司中发明了SFE并在飞行员临床上进行了测试 试验。 Veravanti拥有用于医学成像的SFE技术的独家许可，并且3-- 通道全彩色SFE（使用红色，绿色和蓝色反射率）已经在试点制造和测试中。 该项目将迅速将4通道MMSFE技术转化为荧光的特定产品 GI区域中的指导内窥镜干预措施。此外，Veravanti mmsfe将为 具有模块化格式的有效制造，其零件数量减少和预期的成本降低。 该应用程序正在使用密歇根大学开发的NIR荧光分子问题 （UM）与食管腺癌（EAC）的高级发育不良（HGD）和肿瘤细胞结合。 MMSFE产品是通过常规内窥镜的工作渠道引入的，以识别 过度表达EGFR和ERBB2的下方食道，它们是跨膜酪氨酸激酶 刺激上皮细胞生长，增殖和分化的受体。这些目标的过表达 反映了生物侵略性的提高和向巴雷特食管HGD进展的更高风险 和EAC。 MMSFE诊断算法的设计基于荧光的高相关性 与UW和UM合作的病变目标到背景测量。其他MMSFE指导工具 将开发使用NIR荧光分子问题进行更准确的内窥镜干预措施。两个都 软件和硬件将用于使用MMSFE进行多站点临床试验的开始和测试。