Multimodal Spectroscopic Evaluation of Cervical Cancer

宫颈癌的多模态光谱评估

• 批准号: 7160598
• 负责人: Shabbir Bakir Bambot
• 金额: $ 69.08万
• 依托单位: GUIDED THERAPEUTICS
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-04-01 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7160598
• 关键词: biopsy; cervix; cervix neoplasms; clinical research; diagnosis; endoscopy; female reproductive system disorder diagnosis; lead; literature survey; neoplasm /cancer; performance; sectioning; tissues

DESCRIPTION (provided by applicant): Cervical Cancer is the second most common type of cancer in women worldwide and the leading cause of cancer related mortality in women in developing countries. Early detection and diagnosis can saves lives and reduce the burden on the national healthcare system. We have built a non-invasive research-prototype point-of-care device to detect early cancerous conditions of the uterine cervix. We have tested this prototype in a multi-center pre-pivotal study accruing data from more than 600 women for training our algorithm. We have now started our pivotal study using an FDA reviewed protocol and have collected data from 702 subjects as of this writing. We will also test a pre- production version of our device in this pivotal study. This device, which has now been designed and built as part of a fast track SBIR grant 4R44CA110149, is a cost and size reduced, portable, rugged and more user-friendly than the research prototype. It is identical to the commercial device without incurring the tooling costs necessary to enter the production phase. The current pivotal study data accrual from 720 subjects is funded by our prior Phase II grant award 2R44CA086626. However the FDA has recommended changes in our claims and claim benchmarks resulting in an increase in subject accrual to justify a PMA submission. In this Phase II continuation effort, we will accrue data from an additional 930 subjects. This additional accrual will give us the 1500 subject data required by FDA to meet our claim benchmarks. Upon completing this additional accrual we will continue with the remaining aims of our original grant award viz. validate the algorithm on all pivotal data and prepare and submit the clinical PMA application to the FDA. Cervical cancer is the second most common type of cancer in women worldwide and one of the leading causes of cancer related deaths in women in developing countries. Like all cancers, it is preventable if detected and treated early. Currently, the major obstacles to detection and treatment are inaccurate and painful tests and delays in obtaining results. Spectroscopic diagnosis has the potential of removing all of these obstacles. Thus it not only improves care and quality of life for women suffering from this cancer but also reduces the burden that this cancer poses on health care costs worldwide.

描述（由申请人提供）：宫颈癌是全球妇女中第二常见的癌症类型，也是发展中国家女性癌症相关死亡率的主要原因。早期发现和诊断可以挽救生命，并减轻国家医疗保健系统的负担。我们已经建立了一种非侵入性研究 - 预型护理设备，以检测子宫宫颈的早期癌性疾病。我们已经在一项多中心前研究中测试了该原型，该研究收集了600多名女性培训我们的算法的数据。现在，我们已经使用FDA审查协议开始了关键研究，并在撰写本文时收集了702名受试者的数据。我们还将在这项关键研究中测试设备的预生产版。该设备现在是作为快速轨道SBIR Grant 4R44CA110149的一部分设计和构建的，它是成本和尺寸降低，便携式，坚固耐用，并且比研究原型更易于用户友好。它与商业设备相同，而不会产生进入生产阶段所需的工具成本。我们先前的II期授予奖2R44CA086626资助了720名受试者的当前关键研究数据应计。但是，FDA建议对我们的索赔进行更改和主张基准，从而增加了受试者的增加，以证明PMA提交是合理的。在此阶段II延续工作中，我们将获得来自其他930名受试者的数据。这项额外的应计将为我们提供FDA所需的1500个主题数据，以满足我们的索赔基准。完成这一额外的应计，我们将继续以我们原始赠款奖的其余目标（即。验证所有关键数据上的算法，并准备并将临床PMA应用程序提交给FDA。宫颈癌是全世界女性中第二常见的癌症类型，也是发展中国家女性癌症与癌症有关的主要原因之一。像所有癌症一样，如果检测到和治疗，则可以预防。当前，检测和治疗的主要障碍是获得结果的不准确和痛苦的测试和延迟。光谱诊断具有消除所有这些障碍的潜力。因此，它不仅可以改善患有这种癌症的女性的护理和生活质量，而且减轻了这种癌症对全球医疗保健成本造成的负担。