Targeted fusion biopsy using anti-[18F]FACBC PET/CT and real-time 3D ultrasound g

描述(申请人提供)：每一个45岁以上的男性都有患前列腺癌的风险。二维(2D)经直肠超声(TRUS)引导活检是前列腺癌诊断的标准方法。这种TRUS引导的活检方法的一个关键问题是其严重的抽样误差和低灵敏度(24%-52%)。目前的活检方法可能会漏掉高达30%的前列腺癌。然而，每年进行的前列腺活检超过120万例，活检费用超过20亿美元。创新的图像引导活检技术可以改善癌症检测，可以对这种影响六分之一男性的疾病的管理产生重大影响。这项研究的目的是评估一种新的、分子图像导向的、三维(3D)超声引导的人类患者活检系统。在我们由NIH资助的Emory分子和翻译成像中心，研究表明，在前列腺癌检测中，使用新型PET分子成像剂FACBC的PET/CT成像比FDA批准的SPECT/CT更敏感。FACBC图像显示肿瘤病灶的摄取率高于正常前列腺，是指导前列腺靶向活检的理想信息。这种新开发的活检系统具有一个独特的功能，即FACBC PET/CT图像可以与3D超声图像配准，从而将可疑的PET病变叠加到实时超声数据上；然后使用融合图像将活检针引导到肿瘤靶点。这项研究的假设是，FACBC PET/超声融合引导活检每个核心可以检测到比标准12核心TRUS引导活检更多的癌症。具体目标包括：1)开发FACBC PET/CT和人类患者3D超声图像的可变形配准和融合的工作流程；2)进行FACBC PET/CT引导的3D超声引导活检，并确定靶向融合活检是否可以比2D TRUS引导活检发现更多的癌症。36名在接受放射治疗等明确治疗后怀疑前列腺癌复发的患者将被纳入这项研究。大约有HAL的患者将有阳性的影像发现，并将接受2D TRUS引导下的活检以及PET/超声融合活检。这项拟议的研究将是第一次使用PET/CT成像指导三维超声引导的前列腺活检的人体试验。多模式成像方法将结合PET的高灵敏度和超声波的实时信息来改进癌症检测。这一早期临床试验将有助于将该领域从目前的“盲目”活检转变为未来的“靶向”活检，并导致前列腺癌治疗的变化。这项新的活检技术可以通过提高前列腺癌的检测和诊断能力，对患者护理产生立竿见影的影响。

DESCRIPTION (provided by applicant): Every man over the age of 45 is at risk for prostate cancer. Two-dimensional (2D) trans rectal ultrasound (TRUS) guided biopsy is the standard method for prostate cancer diagnosis. A critical problem of this TRUS- guided biopsy approach is its significant sampling error and its low sensitivity (24%-52%). Current biopsy approaches may miss up to 30% of prostate cancer. Nevertheless, more than 1.2 million prostate biopsies are performed in each year and the biopsy cost is more than two billion dollars. Innovative image-guided biopsy technology that can improve cancer detection can have significant impact on the management of this disease that affects one in six men. The objective of the proposed study is to evaluate a new, molecular image directed, three-dimensional (3D) ultrasound guided biopsy system in human patients. At our NIH-funded Emory Molecular and Translational Imaging Center, it has been shown that PET/CT imaging with a new, PET molecular imaging agent i.e., FACBC, is more sensitive than the FDA-approved SPECT/CT in prostate cancer detection. FACBC images showed higher focal uptake in tumor foci than in normal prostate and thus could be ideal information to direct targeted biopsy of the prostate. This newly developed biopsy system has a unique feature that FACBC PET/CT images can be registered with 3D ultrasound images, as a result, a suspicious PET lesion is superimposed over the real-time ultrasound data; and the fused image is then used to direct biopsy needles to tumor targets. The hypothesis of the study is that FACBC PET/ultrasound fusion guided biopsy can detect more cancer per core than the standard 12-core TRUS guided biopsy. The specific aims include: 1) To develop the workflow for performing deformable registration and fusion of FACBC PET/CT and 3D ultrasound images of human patients, and 2) To perform FACBC PET/CT directed, 3D ultrasound-guided biopsy and determine if targeted fusion biopsy can detect more cancer than 2D TRUS-guided biopsy. Thirty six patients, who have suspicion of recurrent prostate cancer after definitive therapy such as radiotherapy, will be recruited into this study. Approximately hal of the patients will have positive imaging findings and will undergo 2D TRUS-guided biopsy as well as PET/ultrasound fusion biopsy. The proposed study will be the first-in-human trial that uses PET/CT imaging to direct 3D ultrasound-guided biopsy of the prostate. The multimodality imaging approach will combine the high sensitivity from PET and real-time information from ultrasound for improved cancer detection. This early-phase clinical trial will help transform the field from the current "blind" biopsy to future "targeted" biopsy and result in the change of prostate cancer management. The new biopsy technology can have an immediate impact on patient care by improving the detection and diagnosis of prostate cancer.