A Novel Needle-Based X-Ray System

描述（由申请人提供）：该项目的长期目标是开发、临床测试和商业化AXT开发的新型可插入X射线器械。该便携式X射线针预期用于直接向肿瘤床输送低能量、高RBE辐射，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品。AXT X射线设备的主要优点包括可控的开/关模式、产生的辐射的特殊稳定性、可调节的剂量率以及在传统手术室中几乎没有辐射暴露给工作人员的能力。该装置的最初应用是加速部分乳房照射。第二阶段项目的主要目标是设计、构建和测试一种新型号的X射线针，其产生的辐射剂量率较高（在组织中10 mm处为1 Gy/min）。其他目标包括开发低能量（8-18 keV）剂量测定方案和涉及X射线针的治疗计划方法。为了实现既定目标，必须实现项目的以下具体目标。该项目的具体目标是：（i）设计、构建和测试由高定向热解石墨制造的椭圆形和Johansson型集中器，（2）将集中器结合到光学准直器中，（3）将准直器结合到X射线针中，（4）执行剂量率和剂量率空间分布（等剂量）的测量，（5）设计并制作了一个气囊施放器，并将其与X射线针连接进行了测试。（6）将X射线针装置安装在传统的活动臂上。据估计，美国每年有超过275，000名妇女被诊断患有乳腺癌，其中约50%接受放射治疗。AXT新型可插入式X射线设备的开发为许多受影响的人的治疗和生活质量的改善提供了希望和承诺。

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.