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

使用抗[18F]FACBC PET/CT 和实时 3D 超声进行靶向融合活检

• 批准号: 8509090
• 负责人: BAOWEI FEI
• 金额: $ 28.84万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8509090
• 关键词: Affect; Age; Biopsy; Biopsy Specimen; Cancer Detection; Capromab Pendetide; Carcinoma; Cicatrix; Clinic; Clinical; Clinical Trials; Computer software; Data; Deformity; Detection; Devices; Diagnosis; Disease Management; FDA approved; Funding; Future; Gland; Healthcare; Human; Image; Image Guided Biopsy; Imaging technology; Incidence; Laboratories; Lesion; Malignant Neoplasms; Malignant neoplasm of prostate; Methods; Molecular; Needle biopsy procedure; PET/CT scan; Patient Care; Patient observation; Patients; Phase; Positron-Emission Tomography; Premalignant; Prostate; Prostate carcinoma; Prostate-Specific Antigen; Publishing; Radiation therapy; Recruitment Activity; Recurrence; Risk; Sampling Errors; Speed; System; Technology; Three-Dimensional Image; Time; Tissues; Tracer; Translations; Transrectal Ultrasound; Ultrasonography; United States National Institutes of Health; base; blind; cancer diagnosis; cancer risk; clinically significant; cost; experience; follow-up; hormone therapy; image registration; improved; innovation; man; men; molecular imaging; multimodality; public health relevance; rectal; single photon emission computed tomography; standard of care; tumor; two-dimensional; uptake

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.

描述（由申请人提供）：45岁以上的每个人都有前列腺癌的风险。二维（2D）反直肠超声（TRUS）引导活检是前列腺癌诊断的标准方法。这种trus引导活检方法的一个关键问题是其明显的采样误差和低灵敏度（24％-52％）。当前的活检方法可能会错过多达30％的前列腺癌。然而，每年进行超过120万个前列腺活检，活检成本超过20亿美元。可以改善癌症检测的创新图像引导的活检技术可能会对影响六分之一男性的这种疾病的管理产生重大影响。拟议的研究的目的是评估人类患者的新的，三维（3D）超声引导的活检系统的新分子图像。在我们的NIH资助的Emory分子和翻译成像中心，已经表明，具有新的PET分子成像剂的PET/CT成像（即FACBC）比前列腺癌检测中FDA批准的SPECT/CT更敏感。 FACBC图像在肿瘤灶中的局灶性摄取量高于正常前列腺的局灶性摄取，因此可以是直接对前列腺进行靶向活检的理想信息。这个新开发的活检系统具有独特的功能，可以用3D超声图像进行FACBC PET/CT图像进行注册，因此，可疑的PET病变叠加在实时超声数据上。然后将融合图像用于将活检针引导到肿瘤靶标。该研究的假设是FACBC PET/超声融合引导的活检比标准的12核TRUS指导活检可以检测到每个核心的癌症更多。 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.这项研究将招募36例患者，他们怀疑有重复的前列腺癌（例如放疗）。患者的大约HAL将具有阳性成像发现，并将进行2D TRUS引导的活检以及PET/超声融合活检。拟议的研究将是使用PET/CT成像指导前列腺超声引导活检的第一个人类试验。多模式成像方法将结合PET和超声实时信息的高灵敏度，以改善癌症检测。这项早期临床试验将有助于将现场从当前的“盲”活检转变为对未来的“针对性”活检，并导致前列腺癌管理的变化。新的活检技术可以通过改善前列腺癌的检测和诊断来立即对患者护理产生影响。