Quantitative C-arm Fluoroscopy - Prostate Brachytherapy

描述(申请人提供)：前列腺癌仍然是一个严重的健康问题，无论是在国内还是在世界范围内。大量研究已证明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。近距离放射治疗的成功主要取决于我们是否有能力在术中根据患者的个体解剖来调整放射剂量。因此，这项研究的目标是设计、开发和临床测试一种术中植入的粒子相对于前列腺的定位方法，以实现术中剂量学优化和退出剂量学。近距离放射治疗主要在经直肠超声引导下进行，它提供了足够的软组织解剖的实时可视化，但不显示植入的种子。为了克服这个问题，我们建议将超声对准到术中C臂透视，其中植入的种子将通过透视重建并叠加在超声上。具体地说，我们将：(1)设计一个符合当代前列腺近距离放射治疗实践的系统和工作流程。(2)从C臂透视图像、透视图像空间配准和超声图像重建种子植入物的优化数学算法。(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估试验。我们已经在第一阶段SBIR研究拨款中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，以开发一个临床级别的系统，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FDA随后批准的审查，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.