A low-dose fluoroscope for interventional radiology procedures

描述(由申请人提供)：由于越来越多有效的诊断和影像引导的微创手术和适当增加的利用率，介入放射学和其他医学成像方式的辐射暴露已成为一个严重的问题。FDA最近一项减少医学成像剂量的倡议突显了这一担忧。缓解这一问题是复杂的，因为有许多促成因素，但我们相信，解决方案的一部分是建立以显著较低剂量获取图像的X射线成像设备。本着这种精神，我们建议在SBIR Fast-Track应用中建立一种低剂量、大视野的透视系统，以满足介入放射学的需要。我们预计，与传统系统相比，与传统系统相比，该系统将在同等图像质量下将患者的入射X射线曝光和辐射剂量降低4倍，职业剂量至少降低2倍。我们，Triple Ring Technologies，已经开发出一种用于心脏干预的小视场扫描束数字X射线(SBDX)系统，计划于2010年秋季发布。该系统采用了一种新的成像几何结构，包括一个具有9000个焦点位置的扩展扫描光束X射线源和一个像素化光子计数探测器。从每个焦点位置，一束X射线通过X射线准直器投射到探测器上。最终图像由多达9000个探测器图像组成，实时重建。SBDX系统已经显示出成年患者的剂量减少了4倍。为了实现扩展的视场，我们将使用现有的SBDX系统，用两个横向分布的探测器取代单一的探测器。重要的是，这将需要一个新的X射线准直器，我们确定建造新的准直器是最高的发展风险。我们建议在SBIR快速通道拨款的第一阶段取消这一风险。在赠款的第二阶段，我们将建立大型视野系统，并对我们的系统与传统系统进行比较模型研究，以衡量入院暴露、患者和职业剂量的节省。最后，我们将在猪模型上进行观察者研究，以验证与传统系统相比的图像质量。总之，这项赠款申请建议通过建立和测试低剂量荧光透视系统来降低介入放射学中的辐射风险。 公共卫生相关性：介入放射学是一个不断扩大的领域，仅在美国每年就有超过400万例微创手术。尽管取得了成功，但IR最近受到了密切关注，因为许多手术都是在X射线图像引导下进行的。有强有力的证据表明，IR中发现的高剂量暴露正导致癌症风险显著增加，特别是在年轻患者中。在这项拨款申请中，我们建议通过建立介入放射学所需的具有大视野的低剂量透视系统来解决这一问题。重要的是，我们的系统将使用逆几何结构，带有一个扩展的X射线源和两个小探测器。我们假设，与传统系统相比，我们的系统将在图像质量相同的情况下，将患者剂量减少4倍，职业剂量减少2倍。

DESCRIPTION (provided by applicant): Radiation exposure in interventional radiology and other medical imaging modalities has become a serious concern, driven by the growing number of efficacious diagnostic and image-guided minimally invasive procedures and appropriately increasing utilization. This concern has been underlined by a recent FDA initiative to reduce dose in medical imaging. Alleviating this problem is complex because of the many contributing factors, but we believe that one part of the solution is to build X-ray imaging equipment that acquires images at significantly lower dose. In this spirit, we propose in this SBIR Fast-Track application to build a low-dose fluoroscopic system with a large field of view as required for interventional radiology. We expect that the system will reduce entrance X- ray exposure and radiation dose to the patient by a factor of 4 and the occupational dose by at least a factor of 2 at equal image quality as compared to a conventional system. We, Triple Ring Technologies, have developed a scanning-beam digital X-ray (SBDX) system with a small field of view for cardiac interventions, scheduled for release in fall 2010. The system employs a novel imaging geometry with an extended, scanning-beam X-ray source with 9,000 focal spot positions, and a pixelated photon-counting detector. From each focal-spot position, an X-ray beam is cast through an X-ray collimator onto the detector. The final image, composed of up to 9,000 detector images, is reconstructed in real time. The SBDX system has shown a 4-fold dose reduction in adult patients. To achieve the extended FOV, we will use the existing SBDX system and replace the single detector with two laterally spaced detectors. Importantly, this will require a new X-ray collimator and we determined that construction of the new collimator is the highest development risk. We propose to retire this risk in Phase 1 of the SBIR Fast-Track grant. In Phase 2 of the grant, we will build the large FOV system and perform a comparative phantom study of our system against a conventional system to measure entrance exposure, patient and occupational dose savings. Finally, we will perform an observer study in porcine models to validate image quality in comparison to a conventional system. In conclusion, this grant application proposes to reduce the radiation risk in interventional radiology by building and testing a low-dose fluoroscopy system. PUBLIC HEALTH RELEVANCE: Interventional radiology is an expanding field with over 4 million minimally invasive procedures performed every year in the US alone. Despite its success, IR has recently come under scrutiny because many of the procedures are performed under X-ray image guidance. There is strong evidence that the elevated dose exposures as found in IR are leading to a significantly increased risk of cancer, especially in young patients. In this grant application we propose to address this concern by building a low-dose fluoroscopic system with a large field-of-view as required for interventional radiology. Importantly, our system will use inverse geometry architecture with an extended X-ray source and two small detectors. We hypothesize that our system will offer a 4-fold reduction in patient dose and 2-fold reduction in occupational dose with equivalent image quality as compared to a conventional system.