A Novel Needle-Based X-Ray System

描述(申请人提供)：该项目的长期目标是开发、临床测试AXT公司开发的新型可插入式X射线设备并将其商业化。这种便携式X射线针旨在将低能量、高RBE的辐射直接输送到肿瘤床上，被认为是高剂量率近距离放射治疗中使用的放射源的可行替代方案。AXT的X光设备的主要优势包括可控的开/关模式、产生的辐射的非凡稳定性、可调节的剂量率，以及能够在传统手术室中工作，几乎不会对工作人员造成辐射照射。该装置的初步应用是加速局部乳房照射。第二阶段项目的主要目标是设计、建造和测试一种新的X射线针模型，并提高产生的辐射的剂量率(组织中10 mm的剂量为1Gy/min)。其他目标包括开发低能量(8-18keV)剂量测定方案和一种涉及X射线针的治疗规划方法。为了实现所述目标，必须实现项目的下列具体目标。该项目的具体目标是：(1)设计、建造和测试由高取向热解石墨制成的椭球型和Johansson型聚光器，(2)将聚光器整合到光学准直器中，(3)将准直器整合到x射线针中，(4)进行剂量率和剂量率空间分布(等剂量)的测量，(5)设计和制造气囊敷贴器并对其与x射线针连接进行测试，(6)在传统的活动臂上安装x射线针装置。这种设备的潜在市场是巨大的。据估计，美国每年有超过27.5万名妇女被诊断患有乳腺癌，其中约50%接受了放射治疗。AXT新型可插入式X光设备的开发为许多受影响的人提供了治愈和改善生活质量的希望和希望。

DESCRIPTION (provided by applicant): The long-term objective of the project is to develop, clinically test and commercialize the novel insertable x-ray device developed by AXT. This portable x-ray needle, is intended for delivery of low energy, high RBE radiation directly to the tumour beds and is considered to be a viable alternative to radioactive sources used in the High Dose Rate Brachytherapy. The main advantages of AXT's x-ray device include such features as a controllable on/off mode, exceptional stability of the produced radiation, adjustable dose rate, and the ability to function in a conventional operating room with almost no radiological exposure to staff. The initial application of the device is the accelerated partial breast irradiation. The main goal of the Phase II project is to design, build and test a new model of the x-ray needle with an elevated dose rate of the produced radiation (1Gy/min at 10mm in tissue). Other goals include the development of low-energy (8-18 keV) dosimetry protocols and a treatment planning approach involving the x-ray needle. To achieve the stated goals the following specific aims of the project have to be fulfilled. The specific aims of the project are: (i) design, build and test an ellipsoidal and Johansson type concentrators fabricated from a Highly Oriented Pyrolytic Graphite, (2) incorporate the concentrators into an optical collimator, (3) integrate the collimators into an x-ray needle, (4) perform measurements of dose rate and dose rate spatial distribution (isodose), (5) design and build a balloon applicator and test it jointed with an x-ray needle, (6) install an x-ray needle device in a conventional movable arm. The potential market for such device is significant. It is estimated that more than 275,000 women in the United States are annually diagnosed with breast cancer and about 50% of them are treated with radiotherapy. Development of the new model of AXT's insertable x-ray device offers hope and promise for cure and improvement to the quality of life for many affected people.