Smartphone Confocal Endoscopy for Detecting Cervical Precancer

用于检测宫颈癌前病变的智能手机共焦内窥镜检查

• 批准号: 9554683
• 负责人: Dongkyun Kang
• 金额: $ 19.58万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-12 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9554683
• 关键词: 3D Print; Acetic Acids; African; Algorithms; Area; Benign; Biopsy; Catheters; Cell Density; Cell Nucleus; Cells; Cellular Morphology; Cellular Phone; Cervical; Cervix Uteri; Cessation of life; Clinic; Colposcopy; Confocal Microscopy; Country; Custom; Cytoplasm; Devices; Diagnosis; Diagnostic; Disease; Early Diagnosis; Endoscopes; Endoscopy; Failure; Future; Goals; Health; Histopathology; Human; Human Papillomavirus; Image; Imaging Techniques; Incidence; Lateral; Lead; Lesion; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Malignant neoplasm of esophagus; Mechanics; Methods; Microscope; Morbidity - disease rate; Morphology; Nuclear; Oral; Patient Care; Patients; Performance; Pilot Projects; Resolution; Resources; Risk; Rural; Safety; Scanning; Screening Result; Sensitivity and Specificity; Skin; Specificity; Technology; Testing; Tissues; Translating; Uganda; Visit; Visual; Woman; accurate diagnosis; cost; design; diagnostic accuracy; health disparity; histological image; imaging study; improved; in vivo; in vivo imaging; innovation; low and middle-income countries; mortality; novel strategies; overtreatment; portability; quantitative imaging; screening; smartphone Application; standard of care; tool; treatment services

Project Summary/Abstracts Cervical cancer remains a significant health problem in low- and middle- income countries (LMICs). More than 80% of the 530,000 annual cervical cancer cases and 270,000 annual cervical cancer-related deaths occur in LMICs. Lack of resources for conducting organized screening and treatment services in LMICs leads to late stage diagnosis of cervical malignancy. As a result of this resource shortage, cervical cancer associated mortality rate in east African countries is 27.6 per 100,000, which is unacceptably high when compared to 2.3 per 100,000 in the US. Visual inspection with acetic acid (VIA) and HPV tests are the two low-cost screening approaches commonly utilized in LMICs. Several studies showed that cervical cancer incidence rate can be reduced by screening with HPV and VIA tests and treating the patient accordingly. However, main drawback of the VIA and HPV tests is low specificity, as most women with a positive screening result (80% to 90%) will not have significant cervical malignancy that warrants treatment (i.e., cervical precancer or cancer). The resulting overtreatment exposes low-risk women to unnecessary morbidity and poses a strain on resources. Confocal microscopy provides both high sensitivity (93-100%) and specificity (93-100%) in detecting cervical precancer but its utility in LMICs has been limited due to the high device cost (>$50,000). We are proposing a new approach of accurately diagnosing cervical precancer with a low-cost (<$3,000) smartphone confocal endoscope and providing adequate treatment in a single visit. In this approach, suspected cervical lesions are imaged in vivo with the smartphone confocal endoscope. Cellular morphologies visualized in confocal images are quantitatively analyzed to diagnose cervical precancer and adequate treatment is performed during the same visit. Our approach will improve patient care in two areas: i) with high specificity of confocal microscopy, we will be able to reduce unnecessary overtreatment; and ii) with the low device cost, we will enhance a single- visit, “screen-and-treat” method in rural clinics. In this R21 project, we will develop the smartphone confocal endoscope and conduct a pilot study of imaging cervix in vivo in Uganda. We have previously developed a low- cost smartphone confocal microscope and have demonstrated in vivo confocal skin imaging in Uganda. In this project, we are translating the smartphone confocal microscopy technology for cervical imaging by developing a miniature endoscopic catheter. In Aim 1, we will develop a smartphone confocal endoscope for imaging cervix. We will optimally design i) a low-cost smartphone confocal module that connects with ii) a miniature endoscopic catheter and test the imaging performance. In Aim 2, we will demonstrate in vivo confocal imaging of cervix in patients in Uganda. Confocal images will be analyzed in comparison with corresponding histologic images and preliminary analysis will be conducted on diagnostic accuracy. We strongly believe that our low- cost, smartphone confocal microscopy technology will greatly improve the early diagnosis of a range of conditions, with the ultimate goal of helping to reduce health disparity around the globe.

项目摘要/摘要 在低收入和中等收入国家(LMIC)，宫颈癌仍然是一个严重的健康问题。多过 在每年53万例宫颈癌病例和27万例与宫颈癌有关的死亡中，80%发生在 LMIC。缺乏在低收入国家开展有组织的筛查和治疗服务的资源导致延误 宫颈恶性肿瘤的分期诊断。由于这种资源短缺，宫颈癌与 东非国家的死亡率为每10万人中有27.6人死亡，与2.3人相比，这一数字高得令人无法接受 在美国，每10万人。醋酸目视检查(VIA)和HPV检测是两种低成本的筛查方法 LMIC中常用的方法。多项研究表明，宫颈癌的发病率可以 通过HPV筛查和VIA检测并对患者进行相应治疗而减少。然而，它的主要缺点是 VIA和HPV检测的特异性很低，因为大多数筛查结果为阳性的女性(80%到90%)不会 患有需要治疗的重大宫颈恶性肿瘤(即宫颈癌前病变或癌症)。由此产生的 过度治疗使低风险妇女面临不必要的发病率，并对资源构成压力。共焦 显微镜检查在检测宫颈癌前病变方面具有很高的敏感性(93-100%)和特异性(93-100%) 但由于其高昂的器件成本(&gt；5万美元)，其在LMIC中的应用一直受到限制。我们正在提出一项新的 用低成本(3,000美元)智能手机共焦准确诊断宫颈癌前病变的方法 内窥镜检查并在一次就诊中提供充分的治疗。在这种方法中，可疑的宫颈病变是 用智能手机共焦内窥镜进行活体成像。共聚焦图像中细胞形态的可视化 进行定量分析以诊断宫颈癌前病变，并在 同样的拜访。我们的方法将在两个方面改善患者护理：i)利用共聚焦显微镜的高度特异性， 我们将能够减少不必要的过度治疗；以及ii)由于设备成本较低，我们将加强单一- 走访，“筛查治疗”的方式在乡村卫生室。在这个R21项目中，我们将开发智能手机共焦 并在乌干达进行了一项体内宫颈成像的试点研究。我们之前已经开发出一种低- 价格昂贵的智能手机共焦显微镜，并已在乌干达演示了体内共焦皮肤成像。在这 项目，我们正在将智能手机共焦显微镜技术用于宫颈成像，通过开发 一种微型内窥镜导管。在目标1中，我们将开发用于成像的智能手机共焦内窥镜 宫颈。我们将优化设计i)低成本智能手机共焦模块，与ii)微型 并测试内窥镜导管的成像性能。在目标2中，我们将演示活体共聚焦成像 在乌干达的患者中发现了宫颈病变。共焦图像将与相应的组织学进行比较分析 将对诊断准确性进行图像和初步分析。我们坚信我们的低谷- 成本方面，智能手机共焦显微镜技术将大大提高一系列疾病的早期诊断 这些措施的最终目标是帮助缩小全球各地的健康差距。