SBIR Phase I: Medical Devices for Real-time Radiation Dosimetry at Sub-millimeter Spatial Resolution

这个小企业创新研究第一阶段项目旨在开发一种新型剂量计，用于以亚毫米空间分辨率实时绘制辐射剂量的二维图。剂量计的高空间分辨率对于支持立体定向放射外科（SRS）和立体定向体部放射治疗（SBRT）治疗至关重要。这些快速出现的模式将精确剂量的辐射输送到小的、明确定义的治疗部位，同时最大限度地减少关键相邻解剖结构的暴露。随着SRS/SBRT治疗的年数量接近1，000，000次并且每年增长5-10%，市场需要具有亚毫米分辨率和实时测量能力的剂量计。每个患者治疗计划的常规治疗前验证成为目标应用程序。仅剂量计的市场价值每年就超过1 000万美元。通过安全有效地提供SRS和SBRT治疗，该价值得到放大。 这些模式的使用通过大幅减少治疗过程中的单独会话的数量而极大地影响放射治疗的效率。最终结果是治疗过程的成本降低，每个直线加速器设备单元的患者数量/年增加，以及患者结局的大幅改善。 该项目的智力价值在于结合和调整两种成熟的商业技术（压电聚合物和辐射变色膜）的关键要素，以生产混合剂量计。该剂量计保留了辐射变色胶片的高空间分辨率，同时通过使辐射暴露引起的变化变得可由电子手段实时检测来提高其可用性。在使用过程中，灵活的一次性压电阵列剂量计（PARD）安装在可重复使用的数据采集电子模块中，该模块将测量剂量的图传输给辐射室外的医学物理学家。辐射变色胶片是目前唯一具有亚毫米空间分辨率的剂量计，由于曝光和测量之间的长延迟以及促进测量的额外时间和精力而不方便。该缺点不利地影响其在患者治疗计划的日常验证中的有用性。混合PARD产品提供了一个密集的，灵活的阵列（0.1毫米间距）的探测器，具有独特的能力，剂量测量在亚毫米分辨率在真实的时间。这克服了现有电子阵列设备的关键缺点，现有电子阵列设备不能具有低于5 mm的空间分辨率并且不适合于与SR和SBRT治疗相关联的小辐射场。

This Small Business Innovation Research Phase I project seeks development of a novel dosimeter for 2-D mapping of radiation dose in real-time at sub-millimeter spatial resolution. The high spatial resolution of the dosimeter is essential in supporting stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments. These rapidly emerging modalities deliver precise doses of radiation to small, well defined treatment sites while minimizing exposure of critical neighboring anatomy. With the annual number of SRS/SBRT treatments approaching 1,000,000 and growing 5-10% annually there is a market need for a dosimeter with sub-millimeter resolution and the capability of measuring in real-time. The routine pre-treatment verification of each patient therapy plan becomes a target application. The value of the market for the dosimeter alone exceeds $10 million annually. The value is amplified through enablement of the safe and efficacious delivery of SRS and SBRT treatments. Use of these modalities greatly impacts the efficiency of radiotherapy by substantially reducing the number of individual sessions in a course of treatment. The net result is lower cost for the treatment course, an increase in the number of patients/year for each linear accelerator equipment unit and a large reported improvement in patient outcomes. The intellectual merit of this project lies in combining and adapting key elements of two well-established commercial technologies, piezoelectric polymers and radiochromic film, to produce a hybrid dosimeter. This dosimeter preserves the high spatial resolution of radiochromic film while improving its usability by making the changes caused by radiation exposure to become detectable by electronic means in real-time. During use, the flexible, single-use piezoelectric array dosimeter (PARD) fits into a re-usable data acquisition electronics module that transmits a map of measured doses to a Medical Physicist outside the radiation cell. Radiochromic film, the only current dosimeter with sub-millimeter spatial resolution, is inconvenient owing to the long delay between exposure and measurement as well as the extra time and effort in facilitating the measurements. This drawback adversely impacts its usefulness in the day-to-day verification of patient treatment plans. The hybrid PARD product provides a dense, flexible array (0.1 mm spacing) of detectors with the unique ability for dose measurement at sub-millimeter resolution in real time. This overcomes key drawbacks of existing electronic array devices which are incapable of spatial resolution below 5 mm and unsuitable for the small radiation fields associated with SRs and SBRT treatments.