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.

分子探针正在推动微创光学成像的发展，这些探针可以使用增强对比度 荧光在癌症成像中的应用非常广泛，从癌症的早期诊断到癌症的诊断。 指导干预措施，例如活检使用宽视场荧光成像提供的高灵敏度。 扫描激光灯正在为这些广泛的应用而开发，该平台技术是 SFE – 扫描纤维内窥镜，将亚 1 毫米扫描仪放置在高度柔性轴的尖端。 几种不同的激光波长可以混合并一起扫描，全彩色反射成像 与 4 通道多模态 SFE 中的近红外 (NIR) 荧光成像相结合。 该项目旨在开发用于特定癌症成像的 VerAvanti 4 通道多模态 SFE (mmSFE) 原型 该应用可对食管癌的早期检测和内镜治疗产生重大影响。 VerAvanti 是一家位于华盛顿州雷德蒙德的初创公司，其成立并配备了工程人员 毕业于华盛顿大学 (UW)，SFE 是在该大学发明并进行试点临床测试的 VerAvanti 拥有将 SFE 技术用于医学成像和 3- 商业化的独家许可。 通道全彩色 SFE（使用红色、绿色和蓝色反射率）已进入试点制造和测试阶段。 该项目将快速将4通道mmSFE技术转化为荧光荧光专用产品 此外，VerAvanti mmSFE 专为指导胃肠道内窥镜干预而设计。 采用模块化格式进行高效制造，减少零件数量并降低预期成本。 该应用程序使用密歇根大学开发的近红外荧光分子探针 (UM) 与高度不典型增生 (HGD) 和食管腺癌 (EAC) 肿瘤细胞结合。 mmSFE 产品通过传统内窥镜的工作通道引入，以识别 下食管过度表达 EGFR 和 ErbB2（跨膜酪氨酸激酶） 刺激上皮细胞生长、增殖和分化的受体。 反映了生物攻击性的增加和进展为巴雷特食管的更高风险，HGD， mmSFE诊断算法的设计基于荧光的高相关性。 与 UW 和 UM 合作进行病变目标到背景测量。 将开发使用近红外荧光分子探针进行更准确的内窥镜干预。 将使用 mmSFE 制造和测试软件和硬件，以启动多站点临床试验。