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癌症，也是癌症相关死亡的第二大原因。然而，如果及早发现并切除息肉，结直肠癌在很大程度上是可以预防的。尽管目前的金标准光学结肠镜检查 (OC) 可检测出 90% 以上的结直肠肿瘤；它是侵入性的，可能会让人不舒服、不方便，并且被患者认为是不受欢迎的。此外，即使是经验丰富的内窥镜医师也可能难以到达盲肠，导致结肠的可视化不完整。因此，虚拟结肠镜检查 (VC) 已成为 OC 的替代方案。在 VC 过程中，虚拟相机用于查看根据腹腔 CT 扫描重建的虚拟结肠内壁。然而，当前的 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，可能会产生大量假阳性，或者对 5-9 mm 大小范围内的显着息肉的检出率较低。我们建议通过这项 SBIR 工作将其商业化的新技术是一种改变游戏规则的专利可视化技术，称为“虚拟飞越”技术。该技术对于检测结肠息肉敏感、有效且高效。该提案的总体目标是完成虚拟结肠镜检查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。假设新的可视化技术将能够更好地观察复杂的结肠拓扑，从而更好地检测息肉，特别是那些可能隐藏在胃皱襞后面的息肉。目前的原型已用于评估二十个临床数据集，并取得了良好的结果。然而，在第二阶段之前必须整合伪影消除和用户友好的功能，该技术将用于大规模临床验证试验，从而产生商业产品。此外，我们建议（1）在 160 个数据集的试点研究中生成更有说服力的初步数据，以及（2）将几个尺寸范围为 5-9 毫米的幻影息肉引入临床数据集中，以便提供该技术有效性的统计显着性。幻影息肉将被放置在传统上难以分析的位置，这给 OC 和 OC 带来了严重的检测问题 和当前的 VC 方法。根据文献，当前的 OC 方法可实现 61-91%（平均 80%）的结肠观察。路易斯维尔大学的“飞越 VC 方法”模仿了经典的 OC，其观看率达到了 93.4%，而新的“飞越”方法的观看率达到了 97.5%。更重要的是改进的视角（“天空之眼”）、光学畸变的消除以及 CAD 功能的增强，这将显着提高息肉识别能力，特别是在检测小结肠息肉、隐藏在胃皱襞后面的息肉以及解剖拐点处折叠结肠段中的息肉时。与今天的方法相比，我们预计困难息肉可视化能力的整体提高将达到 30% 以上，我们很高兴能与路易斯维尔大学合作将这项技术商业化。