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: 8586142
• 负责人: Salwa A Elshazly
• 金额: $ 14.88万
• 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 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8586142
• 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; 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癌症，也是癌症相关死亡的第二大原因。然而，如果息肉被发现并及早切除，结直肠癌在很大程度上是可以预防的。虽然光学结肠镜检查（OC），目前的金标准，检测到超过90%的结直肠肿瘤，它是侵入性的，可能是不舒服，不方便，并认为是不可取的患者。此外，即使是有经验的内窥镜医生也可能难以到达盲肠，导致结肠的不完全可视化。因此，虚拟结肠镜检查（VC）已成为OC的替代方案。在VC过程中，虚拟摄像机用于查看从腹腔的CT扫描重建的虚拟结肠的内壁。然而，目前的VC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，或有显着的息肉在5-9毫米的大小范围内的检测率差。我们建议通过这项SBIR工作商业化的新技术是一个改变游戏规则，专利，可视化技术VC，称为“虚拟飞越”技术。该技术是敏感的，有效的，并有效地检测结肠息肉。该提案的总体目标是完成一种用于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，特别是那些可能隐藏在吸器褶皱后面的息肉。目前的原型已被用来评估20个临床数据集，具有良好的效果。然而，伪影消除和用户友好的功能必须在第二阶段之前纳入，在第二阶段中，该技术将用于大规模临床验证试验，从而获得商业产品。此外，我们建议（1）在160个数据集的试点研究中生成更令人信服的初步数据，以及（2）将几个5-9 mm大小范围内的体模息肉引入临床数据集中，以提供该技术有效性的统计学意义。模型息肉将被放置在传统上难以分析的位置，这对两个OC都造成了重大的检测问题。 目前VC的方法。根据文献，目前的OC方法导致结肠的61-91%（平均80%）可见度。路易斯维尔大学在“飞越VC方法”中的工作，模仿经典的OC，导致93.4%的观看率，而新的“飞越”方法导致97.5%的观看率。更重要的是改进的视角（“天空中的眼睛”）、光学失真的缺乏以及增强的CAD功能，这将显著提高息肉识别，特别是在检测小结肠息肉、隐藏在结肠袋褶皱后面的息肉以及在解剖学拐点处的折叠结肠段中的息肉时。我们预计，与今天的方法相比，可视化困难息肉的能力总体提高了30%以上，我们对与路易斯维尔大学将这项技术商业化感到兴奋。