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: 8716706
• 负责人: BAOWEI FEI
• 金额: $ 27.98万
• 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 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8716706
• 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）：每个 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 引导活检方法的一个关键问题是其显着的采样误差和低灵敏度 (24%-52%)。目前的活检方法可能会漏掉高达 30% 的前列腺癌。然而，每年进行超过120万例前列腺活检，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，对这种影响六分之一男性的疾病的治疗产生重大影响。拟议研究的目的是评估人类患者的新型分子图像引导三维 (3D) 超声引导活检系统。在我们 NIH 资助的埃默里分子和转化成像中心，研究表明，使用新型 PET 分子成像剂（即 FACBC）进行 PET/CT 成像在前列腺癌检测中比 FDA 批准的 SPECT/CT 更敏感。 FACBC 图像显示肿瘤灶中的局灶性摄取高于正常前列腺，因此可能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有一个独特的功能，即FACBC PET/CT图像可以与3D超声图像进行配准，从而将可疑的PET病变叠加在实时超声数据上；然后融合图像用于将活检针引导至肿瘤靶点。该研究的假设是，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) 开发对人类患者的 FACBC PET/CT 和 3D 超声图像进行变形配准和融合的工作流程，以及 2) 进行 FACBC PET/CT 引导、3D 超声引导活检并确定是否有针对性融合活检可以比 2D TRUS 引导活检检测更多的癌症。本研究将招募 36 名疑似在放射治疗等明确治疗后复发前列腺癌的患者。大约一半的患者将出现阳性影像学结果，并将接受 2D TRUS 引导的活检以及 PET/超声融合活检。拟议的研究将是首次使用 PET/CT 成像来指导 3D 超声引导前列腺活检的人体试验。多模态成像方法将结合 PET 的高灵敏度和超声波的实时信息，以改进癌症检测。这项早期临床试验将有助于将该领域从当前的“盲目”活检转变为未来的“靶向”活检，并导致前列腺癌治疗的改变。新的活检技术可以通过改善前列腺癌的检测和诊断来对患者护理产生直接影响。