Quantitative C-arm Fluoroscopy - Prostate Brachytherapy

描述（由申请人提供）：前列腺癌仍然是一个重大的健康问题，在国内和世界范围内。经会阴前列腺近距离放射治疗前列腺癌的有效性和安全性已被大量研究证实。近距离放射治疗的成功主要取决于我们术中根据患者的个体解剖结构调整辐射剂量的能力。因此，本研究的目的是设计、开发和临床测试一种方法，用于植入粒子相对于前列腺的术中定位，以实现术中剂量优化和出口剂量测定。近距离放射治疗主要通过经直肠超声引导进行，其提供了软组织解剖结构的充分实时可视化，但不显示植入的粒子。为了克服这个问题，我们建议将超声配准到术中C形臂荧光透视，其中植入的粒子将从荧光透视重建并叠加在超声上。特别是，我们将：（1）设计一个系统和工作流程，这是符合当代实践的前列腺近距离放射治疗。(2)开发优化的数学算法，用于根据C形臂透视图像重建种子植入物，透视和超声成像的空间配准。(3)将算法与现有的商业前列腺近距离放射治疗系统和植入物优化方法相结合。(4)对人类患者进行临床系统性能评价试验。我们已经在SBIR研究资助的第一阶段确定了这种方法的技术可行性。我们正在请求第二阶段的支持，以开发一个临床级系统，并评估其在人类患者身上的技术性能。由此产生的系统将经受住随后FDA批准的审查，并通过商业分散进入广泛的临床使用。

DESCRIPTION (provided by applicant): Prostate cancer continues to be a significant health problem, both domestically and worldwide. Numerous studies have demonstrated the efficacy and safety of transperineal prostate brachytherapy in the therapy of prostate cancer. The success of brachytherapy chiefly depends on our ability to intra-operatively tailor the radiation dose to the patient's individual anatomy. Thus the objective of this research is to design, develop, and clinically test a method for intra-operative localization of the implanted seeds in relation to the prostate, to allow for intra-operative dosimetric optimization and exit dosimetry. Brachytherapy is predominantly performed with transrectal ultrasound guidance, which provides adequate real-time visualization of soft tissue anatomy, but does not show the implanted seeds. To overcome this problem, we propose registration of ultrasound to intra-operative C-arm fluoroscopy, where the implanted seeds will be reconstructed from fluoroscopy and superimposed on ultrasound. In particular, we will: (1) Design a system and workflow that is consistent with contemporary practice of prostate brachytherapy. (2) Develop optimized mathematical algorithms for reconstruction of seed implants from C-arm fluoroscopy images, spatial registration of fluoroscopy and ultrasound imaging. (3) Integrate the algorithms with an existing commercial prostate brachytherapy system and implant optimization methods. (4) Conduct Clinical System Performance Evaluation Trial on human patients. We have established the technical feasibility of this approach in a Phase-1 SBIR research grant. We are requesting Phase-2 support to develop a clinical-grade system and evaluate its technical performance on human patients. The resulting system will withstand the scrutiny of subsequent FDA approval and enter wide-spread clinical use via commercial dispersion.