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

基本信息

批准号：
10031954
负责人：
Rebecca R. Richards-Kortum
金额：
$ 61.45万
依托单位：
RICE UNIVERSITY
依托单位国家：
美国
项目类别：
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/10031954
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

项目摘要

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.

抽象的：宫颈癌曾经是美国女性癌症死亡的主要原因。过去60年实施筛查、诊断和治疗综合方案多年来，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女性癌症死亡的第一或第二大原因国家（中低收入国家）。资源匮乏地区的宫颈癌预防计划因缺乏具有适当临床专业知识的人员，缺乏病理学服务，并且缺乏相关基础设施。涉及多次患者就诊的计划的失访率很高。筛查和治疗中低收入国家已实施一些方法，包括通过 HPV 检测或目视检查进行筛查醋酸（VIA）后立即治疗，减少随访损失；但这些方法导致由于 VIA 和 HPV 检测的特异性较差，导致大规模过度治疗。迫切需要适当的诊断工具，以实现敏感且特定的筛查-诊断-治疗该策略可以在中低收入国家和美国医疗服务欠缺地区的单次患者就诊中执行我们建议开发并验证一种用于全球宫颈检查的低成本多模式移动阴道镜（MMC）筛查-诊断-治疗程序。这款新设备将结合智能手机的成像功能—— 基于 MobileODT 开发的阴道镜，具有光纤共焦的显微成像功能莱斯大学开发的成像探头。 MMC将对整个宫颈进行成像，自动识别可疑区域，并从可疑区域获取核形态测量的共同配准高分辨率图像地区。将在一项针对 300 名女性的研究中开发多模态图像分析算法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女性的研究中得到验证。我们将通过执行以下操作来确定 MMC 在低资源环境提供商中的可行性和可用性：在巴西使用 MMC 进行癌症预防培训课程。我们的学术与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：巴雷托斯癌症医院和联邦健康大学阿雷格里港科学/圣卡萨医院。该领域将开发的创新成像技术该提案将实现有效的单次就诊筛查-诊断-治疗计划，以诊断和治疗患有以下疾病的女性宫颈癌前病变，同时最大限度地减少过度治疗。