Biopsy Tracking and MRI Fusion to Enhance Imaging of Cancer Within the Prostate

描述(申请人提供)：前列腺癌(CAP)是美国男性最常见的内科恶性肿瘤，每年新增19.2万例，死亡2.73万人。然而，帽也以一种常见的、非致命的、不会引起疾病的微不足道的形式存在。多达一半的新诊断的CAP病例在组织学上被认为是微不足道的，但90%的CAP患者，无论是严重的还是非严重的，都选择立即治疗。对前列腺癌进行成像的能力将有助于确定重要的癌症，但目前缺乏这种能力。我们建议评估一种先进的成像系统，Artemis设备，在接受前列腺活检以排除恶性肿瘤的男性中。该设备使用常规超声图像的数字视频处理来(1)创建同时的前列腺3D重建，(2)系统地规划活检点，(3)数字记录活检点以供将来重新调用，以及(4)以实时方式融合或叠加先前获得的前列腺磁共振成像(MRI)和同时的超声图像。这项新技术的潜在优势包括提高了对整个前列腺进行彻底采样的能力，精确地记录采样位置以供将来再次活检，以及直接使用MRI和超声波的图像进行活检定位。当以多模式方式-3Tesla线圈结合动态对比度增强和扩散加权成像-进行前列腺MRI检查时，在显示前列腺癌方面似乎接近临床实用。在目前的研究中，用新的成像系统获得的结果将与(1)接受前列腺切除术的男性(加州大学洛杉矶分校的N=350/年)的整体前列腺病理结果进行比较，以及(2)诊断时的活检结果以及随后接受积极监测的男性的活检结果(南加州巨大的未得到满足的需求)。超声/MRI融合的准确性将通过比较两种模式在前列腺中看到的基准标记的位置来测试。MRI作为活检指南的价值将通过比较针对MRI上看到的可疑病变的活检结果与12核心系统活检的结果来检验。监测臂将为低风险帽男性患者提供纵向测试成像设备的机会，这是一项有组织的、前瞻性的计划。多模式磁共振成像和Artemis设备提供的改进的前列腺成像和精确的活检，可能有助于重新定义重大和微不足道的癌症。

DESCRIPTION (provided by applicant): Prostate cancer (CaP) is the commonest internal malignancy in U.S. males, accounting for 192,000 new cases and 27,300 deaths annually. However, CaP also exists in a common, non-fatal, insignificant form which does not cause disease. Up to half of newly diagnosed CaP cases qualify histologically as insignificant, but 90% of men with CaP, serious and not, choose immediate curative therapy. Ability to image cancer within the prostate would help define the important cancers, but presently that ability is lacking. We propose to evaluate an advanced imaging system, the Artemis device, in men undergoing prostate biopsy to exclude malignancy. The device employs digital video processing of conventional ultrasound images to (1) create a contemporaneous 3D reconstruction of the prostate, (2) plan biopsy sites systematically, (3) digitally record the biopsy sites for future re-call, and (4) fuse or superimpose previously-obtained magnetic-resonance imaging (MRI) of the prostate with concurrent ultrasound images in a real-time manner. Potential advantages of this new technology include improved ability to sample the entire prostate thoroughly, to precisely record sampling sites for future re-biopsy, and to directly use images from MRI as well as ultrasound for biopsy targeting. MRI of the prostate, when performed in a multi-modal fashion---3Tesla coil combined with dynamic contrast enhancement and diffusion-weighted imaging---appears to be approaching clinical utility in visualizing cancer within the prostate. In the present study, results obtained with the new imaging system would be compared with (1) findings on whole-mount prostate pathology, for men undergoing prostatectomy (N=350/yr at UCLA), and (2) biopsy findings at diagnosis and subsequently, for men undergoing active surveillance (vast unmet need in Southern California). Accuracy of ultrasound/MRI fusion would be tested by comparing location of fiducial markers in the prostate seen on each of the two modalities. Value of MRI as a biopsy guide would be tested by comparing results of biopsies targeted at suspicious lesions seen on MRI vs 12-core systematic biopsies. The surveillance arm will provide opportunity for longitudinal testing of the imaging device in men with low- risk CaP in a structured, prospective program. Improved imaging and precise biopsy of the prostate, as provided by multi-modal MRI and the Artemis device, may help re-define significant and insignificant cancer.