Molecular Imaging Directed, 3D Ultrasound-guided, Biopsy System

描述(由申请人提供)：前列腺癌在美国每6名男性中就有1名患病。每个45岁以上的男性都有患前列腺癌的风险。系统经直肠超声(TRUS)引导的活检是确诊前列腺癌的标准方法。每年进行的前列腺活检超过120万例，每年的医疗费用超过20亿美元。然而，这种技术有很大的采样误差，并且具有灵敏度低(39-52%)的特点。这种“盲目”的活组织检查方法可能会漏掉30%的前列腺癌。由于阴性活检不排除漏诊癌症的可能性，医生和患者在做出治疗决定时都面临着挑战。由于越来越多的年轻男性可能患有早期和可治愈的前列腺癌，为了提高癌症的发现率，这个问题必须得到解决。在我们由NIH/NCI支持的Emory分子和翻译成像中心，使用新型分子成像示踪剂FACBC的正电子发射断层扫描(PET)在人类患者前列腺癌检测中显示出非常有希望的结果。我们假设FACBC PET分子图像可以结合到超声引导的活检中，以改进癌症检测。这项拟议的研究旨在开发一种分子图像导向、三维超声引导的系统，用于前列腺癌的靶向活检。具体目标1：改进一种实时的、机械辅助的三维超声引导设备。与传统的2D图像引导相比，前列腺的3D图像将被用于指导活检。具体目标2：建立快速变形和基于统计外观模型的前列腺三维超声图像分割方法。统计形状模型将从我们的数据库中开发出来，并将用于指导前列腺的自动分割。具体目标3：将FACBC分子图像与三维超声相结合进行靶向活检。为了解决基于互信息的图像配准的主要局限性，将开发新的基于联合显著图和模糊点对应的可变形图像配准方法。具体目标4：在幻影和动物身上测试综合活检系统的准确性。完整的活组织检查系统也将在少数人类患者身上进行测试。我们的FACBC患者研究得到了NIH赞助的成像中心计划(P50CA128301)和第二阶段临床试验(NCT00562315)的支持。这种机械辅助设备已经获得了FDA 510K的批准。拟议的研究将促进学术-产业合作(埃默里大学、西安大略大学罗巴茨研究所和加利福尼亚州草谷的Eigen Inc.)。如果完全开发，多模分子图像引导系统不仅可以用于活检，还可以用于近距离放射治疗、射频热消融、冷冻和光动力学治疗。

DESCRIPTION (provided by applicant): Prostate cancer affects 1 in 6 men in the USA. Every man over the age of 45 is at risk for prostate cancer. Systematic transrectal ultrasound (TRUS)-guided biopsy is the standard method for a definitive diagnosis of prostate cancer. More than 1.2 million prostate biopsies are performed annually and the medical cost is more than two billion dollars each year. However, this technique has a significant sampling error and is characterized by low sensitivity (39-52%). This "blind" biopsy approach can miss 30% of prostate cancers. As a negative biopsy does not preclude the possibility of a missed cancer, both the physicians and patients face challenges in making treatment decisions. Due to the increasing number of younger men with potentially early and curable prostate cancer, this problem must be addressed in order to improve cancer detection rate. At our NIH/NCI-supported Emory Molecular and Translational Imaging Center, positron emission tomography (PET) with a new molecular imaging tracer FACBC has shown very promising results for prostate cancer detection in human patients. We hypothesize that FACBC PET molecular images can be incorporated into ultrasound-guided biopsy for improved cancer detection. The proposed research is to develop a molecular image-directed, 3D ultrasound-guided system for targeted biopsy of the prostate. Specific Aim 1: To modify a real-time, mechanically assisted, 3D ultrasound-guided device. Compared to conventional 2D image guidance, 3D images of the prostate will be used to guide the biopsy. Specific Aim 2: To develop fast deformable and statistical appearance model based segmentation methods for 3D ultrasound images of the prostate. Statistical shape models will be developed from our database and will be used to guide automatic segmentation of the prostate. Specific Aim 3: To combine FACBC molecular images with 3D ultrasound for targeted biopsy. New deformable image registration methods based joint saliency map and fuzzy point correspondence will be developed in order to solve major limitations of mutual information based image registration. Specific Aim 4: To test the accuracy of the integrated biopsy system in phantoms and animals. The complete biopsy system will also be tested in a small number of human patients. Our FACBC patient studies are supported by the NIH-sponsored imaging center program (P50CA128301) and by the Phase II Clinical Trial (NCT00562315). The mechanically assisted device has received the FDA 510K approval. The proposed study will promote the academic-industrial collaboration (Emory University, Robarts Research Institute of the University of Western Ontario, and Eigen Inc., Grass Valley, CA). If completely developed, the multimodality molecular image-guided system will be able to be used not only for biopsy but also for brachytherapy, radiofrequency thermal ablation, cryotherapy, and photodynamic therapy.