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 宫颈癌仍然是低收入和中等收入国家 (LMIC) 的一个重大健康问题。多于 每年 530,000 例宫颈癌病例和 270,000 例宫颈癌相关死亡中的 80% 发生在 中低收入国家。中低收入国家缺乏开展有组织的筛查和治疗服务的资源，导致晚期 宫颈恶性肿瘤的分期诊断。由于资源短缺，宫颈癌与 东非国家的死亡率为每10万人中27.6人，与2.3人相比，这一数字高得令人无法接受 在美国每 100,000 人中。醋酸目视检查 (VIA) 和 HPV 检测是两种低成本筛查方法 中低收入国家普遍采用的方法。多项研究表明，宫颈癌的发病率可 通过 HPV 和 VIA 检测筛查并相应治疗患者来减少。然而，主要缺点是 VIA 和 HPV 检测的特异性较低，因为大多数筛查结果呈阳性的女性（80% 至 90%）不会 患有需要治疗的严重宫颈恶性肿瘤（即宫颈癌前期或癌症）。由此产生的 过度治疗使低危妇女遭受不必要的发病，并对资源造成压力。共焦 显微镜检查在检测宫颈癌前病变方面具有高灵敏度 (93-100%) 和特异性 (93-100%) 但由于设备成本较高（> 50,000 美元），其在中低收入国家的实用性受到限制。我们正在提议一个新的 使用低成本（<3,000 美元）智能手机共聚焦准确诊断宫颈癌前病变的方法 内窥镜并在一次访问中提供充分的治疗。在这种方法中，可疑的宫颈病变是 使用智能手机共焦内窥镜进行体内成像。共焦图像中可视化的细胞形态 进行定量分析以诊断宫颈癌前病变，并在治疗期间进行适当的治疗 同样的访问。我们的方法将在两个领域改善患者护理：i）具有高度特异性的共聚焦显微镜， 我们将能够减少不必要的过度治疗； ii）凭借较低的设备成本，我们将增强单 参观农村诊所的“筛查和治疗”方法。在这个 R21 项目中，我们将开发智能手机共焦 内窥镜并在乌干达进行了宫颈活体成像试点研究。我们之前开发了一种低 成本智能手机共焦显微镜，并在乌干达展示了体内共焦皮肤成像。在这个 项目中，我们正在通过开发将智能手机共焦显微镜技术转化为宫颈成像 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) 一个低成本智能手机共焦模块，该模块可连接 ii) 一个微型 内窥镜导管并测试其成像性能。在目标 2 中，我们将演示体内共焦成像 乌干达患者的子宫颈。共焦图像将与相应的组织学图像进行比较分析 将对诊断准确性进行图像和初步分析。我们坚信，我们的低 成本，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 条件，最终目标是帮助缩小全球健康差距。