Omniview tethered capsule for low cost, non-endoscopic Barrett's esophagus screening in unsedated patients

Omniview 系留胶囊用于对未镇静患者进行低成本、非内窥镜巴雷特食管筛查

• 批准号: 10431960
• 负责人: JAMES G FUJIMOTO
• 金额: $ 32.57万
• 依托单位: MASSACHUSETTS INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-06 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10431960
• 关键词: Algorithmic Software; Algorithms; Back; Barrett Esophagus; Biopsy; Blinded; Blood Vessels; Boston; Classification; Clinic; Clinical; Clinical Research; Color; Communities; Computer software; Consultations; Data; Data Set; Deglutition; Detection; Development; Devices; Diagnosis; Dysplasia; Endoscopic Biopsy; Endoscopy; Esophageal Adenocarcinoma; Esophageal mucous membrane; Esophagus; Family suidae; Gastroenterologist; Gastroenterology; Gastroesophageal reflux disease; Healthcare Systems; Histology; Human; Image; Image Analysis; Imaging Techniques; Incidence; Institutes; Interdisciplinary Study; Label; Length; Lesion; Light; Lighting; Machine Learning; Malignant Neoplasms; Maps; Massachusetts; Measures; Methods; Modernization; Monitor; Morbidity - disease rate; Mucous Membrane; Nurse Practitioners; Patient imaging; Patients; Performance; Periodicity; Population; Primary Care Physician; Primary Health Care; Procedures; Protocols documentation; Radiofrequency Interstitial Ablation; Reader; Reading; Recording of previous events; Referral and Consultation; Research Personnel; Resolution; Risk; Screening Result; Sedation procedure; Sensitivity and Specificity; Series; Side; Software Design; Stomach; Surface; Survival Rate; System; Techniques; Technology; Texture; Time; Tissues; Training; United States Department of Veterans Affairs; Validation; advanced disease; automated analysis; automated image analysis; base; capsule; clinical imaging; convolutional neural network; cost; design; graphical user interface; image processing; imaging software; imaging study; improved; medical schools; mortality; navigation aid; novel; optical imaging; patient population; point of care; preclinical study; programs; recruit; screening

Esophageal adenocarcinoma (EAC) is among the most lethal malignancies with a 19% five-year survival rate and its incidence has increased several fold in the last decades. Barrett’s esophagus (BE) confers elevated risk for progression to EAC. Patients diagnosed with BE undergo periodic surveillance endoscopy with biopsies to detect dysplasia which can be treated by endoscopic eradication with radiofrequency ablation before it progresses to EAC. However, the majority of diagnosed EAC patients have not had prior screening endoscopy and present with advanced lesions that limit treatment options and result in poorer survival. The development of a rapid, low cost, well tolerated, non-endoscopic BE screening technique that can be performed in unsedated patients at points of care outside the endoscopy suite would improve BE detection and reduce EAC morbidity and mortality. Our program is a multidisciplinary collaboration among investigators at the Massachusetts Institute Technology and Veteran Affairs Boston Healthcare System / Harvard Medical School that integrates novel optical imaging and software design, preclinical studies in swine, clinical studies in patients, and advanced image processing / machine learning. Aim 1 will develop an omniview tethered capsule technology that generates a map of the esophageal mucosa over a multi-centimeter length of esophagus and a series of wide angle forward views to aid navigation as the capsule is swallowed or retracted. The images will resemble endoscopic white light or narrow band imaging, but will not suffer from perspective distortion present in standard endoscopic or video capsule images. This will facilitate development of automated BE detection algorithms as well as enhance their sensitivity and specificity. This aim will also perform imaging studies in swine as a translational step toward clinical studies. Aim 2 will determine reader sensitivity and specificity for BE detection versus standard endoscopy / biopsy and prepare data for developing automated BE detection. Patients undergoing screening as well as with history of BE undergoing surveillance will be recruited and unsedated capsule imaging will be performed on the same day prior to their endoscopy. Sensitivity and specificity for detecting BE will be assessed using multiple blinded readers and data sets suitable for developing automated BE detection algorithms will be developed. Aim 3 will develop image analysis methods for automated BE detection by investigating classifiers that operate on handcrafted features (colors and textures) and modern deep convolutional neural network methods for direct classification. If successful, this program will develop a rapid, low cost and scalable method for BE screening that would not require patient sedation, endoscopy, or tissue acquisition, and which could be performed in community primary care clinics. The procedure would be much faster and many times lower cost than endoscopy. Automated BE detection would enable immediate results for patient consultation and referral to gastroenterology if indicated. Larger patient populations with expanded risk criteria could be cost effectively screened and access to screening dramatically improved, reducing EAC mortality.

食管腺癌（EAC）是最致命的恶性症之一，五年生存率为19％ 在过去的几十年中，它的发病率增加了几倍。 为了向EAC进行诊断的患者。 检测可通过射频消融前消除内窥镜消除可以信任的发育不良 但是，大多数已诊断出的EAC患者的内窥镜检查 并出现治疗选择的晚期病变，并导致生存率较差 快速，低成本，耐受性良好的非镜头筛选技术，可以在未编辑中进行 内窥镜套件以外的护理点的患者可以改善检测并减少EAC病态 和死亡率。 技术和资深AFAIRS波士顿医疗保健系统 /哈佛医学院，整合新颖的光学 成像和软件设计，猪的临床前研究，患者的临床研究和高级图像 加工 /机器学习。 食管多中心的食管粘膜图和一系列广角前 随着胶囊吞咽或缩回图像的视图。 轻度或狭窄的频带成像，但不会在标准内镜或 视频胶囊图像。 他们的敏感性和特异性也将在猪中进行成像研究 临床研究2。 内窥镜检查 /活检并准备数据以开发自动化的数据。 随着经过监视的历史将被招募，卸载的胶囊成像将要一直是 在内窥镜检查前的同一天进行敏感性和检测的特异性 使用多个盲目的读者和适合开发自动算法的数据集将是 开发的AIM 3将通过研究分类器来开发自动化的图像分析方法 在手工制作的功能（颜色和纹理）和现代深度卷积神经网络上运行 直接分类的方法。 筛查不需要患者镇静，内窥镜检查或组织呼吸措施，并且可以是 在社区初级保健诊所进行的过程将更快，而且成本较低 比内窥镜检查。 具有扩大风险标准计数的较大顾问人群昂贵 筛选并获得筛选巨大的改进，从而减少了EAC Mortallity。