Virtual Fly-Over Colonoscopy System for Clinical Test-SBIR Phase 1

用于临床测试的虚拟飞越结肠镜检查系统-SBIR 第一阶段

• 批准号: 8735905
• 负责人: Salwa A Elshazly
• 金额: $ 14.33万
• 依托单位: KENTUCKY IMAGING TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-17 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8735905
• 关键词: Abdominal Cavity; Area; Cancer Etiology; Cecum; Cessation of life; Clinical; Clinical Trials; Colon; Colon Carcinoma; Colonic Polyps; Colonoscopy; Colorectal Cancer; Colorectal Neoplasms; Complex; Computational Geometry; Computed Tomographic Colonography; Computer Graphics; Computer Vision Systems; Data; Data Set; Databases; Detection; Development; Early Diagnosis; Effectiveness; Engineering; Excision; Eye; Flying body movement; Foundations; Funding; General Population; Goals; Gold; Helicopter; Human; Imagery; Implant; Kentucky; Lead; Legal patent; Literature; Location; Medial; Medical center; Methods; Morbidity - disease rate; Morphologic artifacts; Optical Methods; Optics; Patients; Phase; Pilot Projects; Polyps; Population; Positioning Attribute; Procedures; Reading; Rivers; Science; Second Primary Cancers; Sedation procedure; Small Business Innovation Research Grant; Surface; System; Techniques; Technology; Testing; Universities; Validation; Work; X-Ray Computed Tomography; base; clinically significant; design; experience; fly; improved; new technology; novel; prototype; public health relevance; research clinical testing; screening; three-dimensional modeling; user-friendly; virtual

DESCRIPTION (provided by applicant): Colorectal cancer is the third most common form of cancer and the second leading cause of cancer-related death in the US. Yet, if polyps are detected and removed early, colorectal cancer is largely preventable. Although optical colonoscopy (OC), the current gold standard, detects more than 90% of colorectal neoplasms; it is invasive and can be uncomfortable, inconvenient, and perceived as undesirable by patients. Furthermore, even experienced endoscopists may have difficulty reaching the cecum, resulting in incomplete visualizations of the colon. As a consequence, virtual colonoscopy (VC) has emerged as an alternative to OC. During VC, a virtual camera is used to view the internal walls of a virtual colon, reconstructed from CT scans of the abdominal cavity. However, current VC systems have had limited clinical appeal, as they are limited to specific types of polyps, may generate a large number of false positives, or have poor detection rates for significant polyps in the size range of 5-9 mm. The new technology we propose to commercialize through this SBIR work is a game changing, patented, visualization technique for VC, called the "virtual fly-over" technique. The technique is sensitive, effective, and efficient for detecting colon polyps. The overall objective of this proposal is to complete the development and validation of a novel visualization technique for virtual colonoscopy, which was patented by the University of Louisville. The hypothesis is that the new visualization technique will enable better viewing of the complex colonic topology, and hence a better capability to detect polyps, especially those that may be hidden behind haustral folds. The current prototype has been utilized to evaluate twenty clinical datasets, with excellent results. However, artifact removal and user friendly features must be incorporated prior to Phase II, in which the technology will be utilized in a larg scale clinical validation trial leading to a commercial product. Also, we propose to (1) generate more convincing preliminary data in a pilot study of 160 datasets, and (2) introduce several phantom polyps, in the size range of 5-9 mm, into the clinical datasets, in order to provide statistical significance of the technology's effectiveness. The phantom polyps will be placed in traditionally difficult-to-analyze positions, which pose significant detection problems for both OC and current VC methods. According to the literature, current OC methods result in a 61-91% (average 80%) viewing of the Colon. The University of Louisville's work in the "fly-through VC method", which mimics classic OC, results in 93.4 percent viewing, and the new "fly-over" method results in 97.5% percent viewing. Even more important is the improved point of view ("eye-in-the-sky"), the lack of optical distortion, and enhanced CAD functionality that will increase polyp recognition dramatically, especially when detecting small colon polyps, polyps hidden behind haustral folds, and polyps in folded colonic segments at anatomical inflection points. We anticipate the overall improvement in the ability to visualize difficult polyps to be upwards of 30% compared to today's methods, and we are excited about commercializing this technology with the University of Louisville.

描述（由申请人提供）：结直肠癌是美国第三大常见的癌症形式，是美国与癌症相关死亡的第二大原因。但是，如果早期检测到息肉并去除息肉，则可以预防结直肠癌。尽管当前的黄金标准是光学结肠镜检查（OC），但可检测到90％以上的结直肠肿瘤。它是侵入性的，可能不舒服，不便，并且被患者认为是不希望的。此外，即使经验丰富的内窥镜医生也可能难以到达盲肠，从而导致结肠的可视化不完全。结果，虚拟结肠镜检查（VC）已成为OC的替代方案。在VC期间，使用虚拟相机来查看通过腹腔CT扫描重建的虚拟结肠的内壁。但是，当前的风险投资系统的临床吸引力有限，因为它们仅限于特定类型的息肉，可能会产生大量的假阳性，或者对于在5-9毫米尺寸范围内的明显息肉的检测率较差。我们建议通过这项SBIR作品进行商业化的新技术是一种更改，专利的可视化技术，称为VC，称为“虚拟飞行”技术。该技术对检测结肠息肉具有敏感，有效且有效。该提案的总体目的是完成对虚拟结肠镜检查的新型可视化技术的开发和验证，该技术已获得路易斯维尔大学的专利。假设是，新的可视化技术将使人们能够更好地观察复杂的结肠拓扑结构，从而更好地检测息肉，尤其是那些可能隐藏的息肉的能力。当前的原型已用于评估二十个临床数据集，结果良好。但是，必须在第二阶段之前纳入伪像的删除和用户友好的功能，其中该技术将在Larg量表临床验证试验中使用，从而导致商业产品。此外，我们建议（1）在160个数据集的试点研究中生成更具说服力的初步数据，（2）在5-9 mm的尺寸范围内引入几个幻影息肉，以便在临床数据集中，以提供该技术有效性的统计学意义。幻影息肉将被放置在传统上难以分析的位置，这两个OC都构成了重大检测问题 和当前的VC方法。根据文献，当前的OC方法导致结肠观看61-91％（平均80％）。路易斯维尔大学在“飞行VC方法”中的作品模仿经典OC，可导致93.4％的观看，而新的“飞蝇”方法可导致97.5％的观看率。更重要的是，改善的观点（“眼睛中的眼睛”），缺乏光学失真和增强的CAD功能，这将大大增加息肉的识别，尤其是在检测到小结肠息肉时，隐藏在haustral褶皱后面的小息肉，以及在解剖学拐点处折叠的结肠斑点中的息肉。我们预计，与当今方法相比，可视化困难息肉的总体提高将超过30％，并且我们很高兴与路易斯维尔大学（University of Louisville）商业化这项技术。