Low-cost mobile colposcopy and confocal imaging for global prevention of cervical cancer

摘要： 宫颈癌曾经是美国女性癌症死亡的主要原因。 在过去60年里，实施了全面的筛查、诊断和治疗方案。 多年来，在美国，宫颈癌的发病率和死亡率降低了70%以上。 癌症仍然是许多低收入和中等收入国家妇女癌症死亡的第一或第二大原因。 中低收入国家。宫颈癌预防计划在低资源环境中受到缺乏 缺乏具有适当临床专业知识的人员、缺乏病理学服务以及缺乏相关基础设施。 涉及多个患者访视的项目失访率很高。筛查和治疗 在中低收入国家实施的方法包括通过HPV检测或目视检查进行筛查， 乙酸（VIA），然后立即治疗，减少失访;但这些方法导致 由于VIA和HPV检测的特异性较差，导致大量过度治疗。迫切需要 适当的诊断工具，以实现敏感和特定的筛查-诊断-治疗 在中低收入国家和美国医疗服务不足的地区， 我们建议开发和验证一种低成本的多模式移动的阴道镜（MMC），用于全球宫颈 筛查-诊断-治疗程序。这款新设备将联合收割机结合智能手机的成像功能- 基于阴道镜开发的MobileODT与光纤共聚焦显微成像能力 莱斯大学开发的成像探针。MMC将对整个子宫颈进行成像，自动识别 可疑区域，并从可疑区域获取核形态测量的共配准高分辨率图像。 地区多模态图像分析算法将在一项涉及300名女性的研究中开发， 在巴西的两个地点进行阴道镜检查。MMC的性能与自动图像分析检测 宫颈癌前病变将在巴西另外760名接受阴道镜检查的妇女的研究中得到验证。 我们将通过以下方式确定MMC在低资源设置提供商中的可行性和可用性： 巴西使用MMC的癌症预防培训课程。 我们的学术-工业合作伙伴关系包括生物工程（莱斯大学），阴道镜检查和 医学成像（MobileODT）、宫颈癌预防和治疗（MD安德森癌症中心），以及 宫颈癌预防和流行病学（阿尔伯特爱因斯坦医学院），以及临床 我们的巴西临床合作伙伴的专业知识：Barretos癌症医院和联邦卫生大学 波尔图阿莱格雷科学/圣卡萨医院。这一领域将开发的创新成像技术 该提案将使有效的单次访问筛查-诊断-治疗计划能够诊断和治疗患有 宫颈癌前病变，同时尽量减少过度治疗。

Abstract: Cervical cancer was once the leading cause of cancer death among women in the United States (U.S.). The implementation of comprehensive programs for screening, diagnosis, and treatment over the past 60 years has reduced cervical cancer incidence and mortality by more than 70% in the U.S. In contrast, cervical cancer remains the 1st or 2nd leading cause of cancer death among women in many low-and middle-income countries (LMICs). Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. Programs that involve multiple patient visits have a high rate of loss to follow-up. Screen-and-Treat approaches have been implemented in LMICs and include screening by HPV testing or visual inspection with acetic acid (VIA) followed by immediate treatment, reducing loss to follow-up; but these approaches lead to massive over-treatment due to the poor specificity of VIA and HPV testing. There is an urgent need for appropriate diagnostic tools to enable the implementation of a sensitive and specific Screen-Diagnose-Treat strategy that can be performed in a single patient visit in LMICs and in medically underserved areas of the U.S. We propose to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical Screen-Diagnose-Treat programs. This new device will combine the imaging capabilities of a smartphone- based colposcope developed by MobileODT with the microscopic imaging capabilities of a fiber-optic confocal imaging probe developed by Rice University. The MMC will image the entire cervix, automatically identify suspicious regions, and acquire co-registered high-resolution images of nuclear morphometry from suspicious areas. Multimodal image analysis algorithms will be developed in a study of 300 women referred for colposcopy at two sites in Brazil. The performance of the MMC with automated image analysis for detection of cervical precancer will be validated in a study of an additional 760 women referred for colposcopy in Brazil. We will determine the feasibility and usability of the MMC among low-resource setting providers by carrying out cancer prevention training courses using the MMC in Brazil. Our academic-industrial partnership includes expertise in bioengineering (Rice University), colposcopy and medical imaging (MobileODT), cervical cancer prevention and treatment (MD Anderson Cancer Center), and cervical cancer prevention and epidemiology (Albert Einstein College of Medicine), as well as the clinical expertise of our Brazilian clinical partners: Barretos Cancer Hospital and the Federal University of Health Sciences of Porto Alegre/Hospital Santa Casa. The innovative imaging technologies to be developed in this proposal will enable effective single-visit Screen-Diagnose-Treat programs to diagnose and treat women with cervical precancer while minimizing overtreatment.