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

低成本移动阴道镜和共焦成像在全球宫颈癌预防中的应用

• 批准号: 10219206
• 负责人: Rebecca R. Richards-Kortum
• 金额: $ 55.33万
• 依托单位: RICE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10219206
• 关键词: Ablation; Acetic Acids; Algorithmic Analysis; Algorithms; Area; Biomedical Engineering; Biopsy; Brazil; Cancer Center; Cancer Etiology; Cancer Hospital; Cellular Phone; Cervical; Cervical Intraepithelial Neoplasia; Cervix Uteri; Cessation of life; Clinical; Clinical Research; Cold Therapy; Collaborations; Colposcopes; Colposcopy; Country; Cytology; Detection; Devices; Diagnosis; Diagnostic; Disease; Equipment; Excision; Fiber Optics; Gold; HPV-High Risk; Health Sciences; Hospitals; Human Papillomavirus; Human Resources; Image; Image Analysis; Imaging technology; Incidence; Infrastructure; Institution; Instruction; Lead; Lesion; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Medical; Medical Imaging; Medically Underserved Area; Medicine; Modeling; Morbidity - disease rate; Multimodal Imaging; Nuclear Atypia; Pathology; Patients; Performance; Prevention program; Provider; Research Personnel; Resolution; Resources; Rice; Sensitivity and Specificity; Services; Site; Specificity; Testing; Thermal Ablation Therapy; Time; Training; United States; Universities; University of Texas M D Anderson Cancer Center; Visit; Visual; Woman; World Health Organization; accurate diagnosis; automated algorithm; automated image analysis; automated visual evaluation; base; cancer epidemiology; cancer prevention; cancer therapy; cervical biopsy; cervical cancer prevention; college; confocal imaging; cost; digital; experience; follow-up; global health; high resolution imaging; image archival system; imaging capabilities; imaging modality; imaging probe; improved; industry partner; innovation; low and middle-income countries; microendoscope; microscopic imaging; morphometry; mortality; multimodality; nuclear imaging; overtreatment; point of care; premalignant; programs; prospective; public health relevance; screening; screening program; standard of care; tool; treatment program; usability

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.

摘要： 宫颈癌曾是美国女性癌症死亡的主要原因。 过去60年来实施的筛查、诊断和治疗综合方案 在美国，多年的宫颈癌发病率和死亡率降低了70%以上。相比之下，宫颈癌 在许多中低收入女性中，癌症仍然是导致癌症死亡的第一或第二大原因 国家(LMIC)。低资源环境下的宫颈癌预防方案因缺乏 具有适当临床专业知识的人员，缺乏病理服务，以及缺乏相关的基础设施。 涉及多次患者就诊的项目有很高的随访率。筛选和处理 已经在LMIC中实施了一些方法，包括通过HPV检测进行筛查或通过 醋酸(VIA)后立即治疗，减少随访的损失；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LMIC和美国医疗服务不足的地区，可以在一次患者访问中执行的战略。 我们建议开发和验证一种低成本的多模式移动镜(MMC)，用于全球宫颈 筛选-诊断-治疗程序。这款新设备将结合智能手机的成像功能- MobileODT开发的具有光纤共焦显微成像能力的镜 莱斯大学研发的成像探头。MMC将对整个宫颈进行成像，自动识别 可疑区域，并从可疑区域获取共同配准的高分辨率核形态测量图像 区域。将在一项对300名女性进行的研究中开发多模式图像分析算法 巴西两个地点的阴道镜检查。具有自动图像分析功能的MMC检测的性能 在对巴西另外760名接受阴道镜检查的妇女的研究中，宫颈癌前病变将得到证实。 我们将通过开展以下工作来确定MMC在低资源设置提供商中的可行性和可用性 使用MMC在巴西举办的癌症预防培训课程。 我们的学术-产业合作伙伴关系包括生物工程(莱斯大学)、阴道镜和 医学成像(MobileODT)、宫颈癌预防和治疗(MD Anderson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：巴雷托斯肿瘤医院和联邦卫生大学 阿雷格里港科学/圣塔卡萨医院。将在这方面开发的创新成像技术 提案将使有效的一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，同时最大限度地减少过度治疗。