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

描述（由申请人提供）：结直肠癌是美国第三大最常见的癌症形式，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。虽然光学结肠镜检查（OC）是目前的金标准，可以检测到90%以上的结直肠肿瘤；它是侵入性的，可能不舒服，不方便，并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，导致结肠的视觉不完整。因此，虚拟结肠镜检查（VC）已成为OC的替代方案。在VC过程中，使用虚拟摄像机查看虚拟结肠的内壁，从腹腔的CT扫描重建。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，或者对5-9毫米大小的重要息肉的检出率很低。我们提议通过这项SBIR工作商业化的新技术是一项改变游戏规则的专利可视化技术，称为“虚拟飞越”技术。该技术对结肠息肉的检测灵敏、有效、高效。该提案的总体目标是完成虚拟结肠镜检查的新型可视化技术的开发和验证，该技术已由路易斯维尔大学获得专利。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鼻翼褶皱后面的息肉。目前的原型已用于评估20个临床数据集，并取得了良好的结果。然而，人工制品去除和用户友好特性必须在第二阶段之前合并，在第二阶段中，该技术将用于大规模的临床验证试验，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有说服力的初步数据，(2)将几个大小在5-9毫米范围内的幻影息肉引入临床数据集，以提供该技术有效性的统计意义。幻息肉将被放置在传统上难以分析的位置，这对两种OC都构成了重大的检测问题

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.