A low-dose fluoroscope for interventional radiology procedures

描述（由申请人提供）：由于越来越多的有效诊断和图像引导的微创手术以及适当增加的应用，介入放射学和其他医学成像方式中的辐射暴露已成为一个严重关注的问题。最近FDA倡议减少医学成像中的剂量，强调了这种担忧。缓解这一问题是复杂的，因为有许多促成因素，但我们认为解决方案的一部分是建造x射线成像设备，以显著降低剂量获取图像。本着这种精神，我们在此SBIR快速通道申请中提出建立介入放射学所需的低剂量大视场透视系统。我们预计，与传统系统相比，该系统在相同图像质量下将使患者的入口X射线暴露和辐射剂量减少4倍，职业剂量减少至少2倍。我们，三环技术公司，已经开发了一种扫描束数字x射线（SBDX）系统，该系统具有用于心脏干预的小视野，计划于2010年秋季发布。该系统采用了一种新颖的成像几何结构，具有9,000个焦点位置的扩展扫描束x射线源和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。最终的图像由多达9000个探测器图像组成，实时重建。SBDX系统在成人患者中的剂量减少了4倍。为了实现扩展视场，我们将使用现有的SBDX系统，并用两个横向间隔的探测器取代单个探测器。重要的是，这将需要一个新的x射线准直器，我们确定新的准直器的建设是最高的开发风险。我们建议在SBIR快速通道拨款的第一阶段取消这一风险。在拨款的第二阶段，我们将建立大型FOV系统，并将我们的系统与传统系统进行比较幻影研究，以测量入口暴露，患者和职业剂量节约。最后，我们将在猪模型中进行观察者研究，以验证与传统系统相比的图像质量。总之，这项拨款申请建议通过建立和测试低剂量透视系统来降低介入放射学中的辐射风险。

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.