REAL TIME ULTRASONIC TISSUE IMAGING FOR PROSTATE CANCER

前列腺癌的实时超声组织成像

• 批准号: 2651896
• 负责人: RICHARD Bruce BERNARDI
• 金额: $ 10万
• 依托单位: SPECTRASONICS, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-01 至 1998-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2651896
• 关键词: biomedical equipment development; biopsy; diagnosis design /evaluation; neoplasm /cancer diagnosis; prostate neoplasms

Spectrasonics Imaging, Inc. proposes a Phase I effort in collaboration with Riverside Research Institute (RRI) to develop a real-time ultrasonic system for indicating regions of the prostate that are suspicious for cancer. Real-time images produced by the system will enable better guidance of needle biopsies. Current ultrasonic guidance of biopsies has an unsatisfactory sensitivity and specificity for prostate cancer. As a consequence, the great majority of prostate biopsies are negative, and may of them are falsely negative. Studies by RRI suggest that the Spectral- Parameter Imaging (SPI) methods underlying the proposed system can improve detection of prostate cancer by 50%, which could detect 150,000 additional cancer annually in the US, reduce the need for repeat biopsies, and permit earlier initiation of treatment. Because RRI's studies are performed in a research setting, achieving the apparent potential of SPI for prostate- cancer detection requires 1) validation of the SPI methods in a clinical setting using a real-time imaging system, and 2) widespread clinical dissemination. The proposed SBIR study seeks to take these steps by developing a real-time imaging system that uses color encoding to depict suspicious regions of the prostate. This color-encoding will be based on spectrum analysis of ultrasonic rf echo signals. We anticipate that biopsy efficacy can be markedly improved through increases in the sensitivity and specificity of such biopsy-guidance images. This proposed Phase I effort will seek to 1) identify the optimal implementation approach for real-time tissue-type imaging, 2) interface the SPI technology with "host" B-mode instruments, 3) formulate PI system specifications, and 4) plan Phase II prototype-construction efforts. Proposed commercial applications: Over 1,000,000 prostate biopsies occur annually in the US alone. Approximately 70% are negative, and over half of the negative biopsies are false. Repeat biopsies have almost the same incidence of positive biopsies as initial biopsies. Unnecessary repeat biopsies and missed cancers impose an enormous dollar cost and patient risk. The proposed SPI methods appear capable of improving cancer detection by 50%, which should make SPI very attractive commercially and valuable medically.

Spectrasonics Imaging，Inc.提出了第一阶段的合作努力， 与滨江研究所（RRI）开发实时超声波 用于指示前列腺可疑区域的系统 癌该系统生成的实时图像将能够更好地 引导穿刺活检。目前超声引导活检， 对前列腺癌的灵敏度和特异性不令人满意。作为 因此，绝大多数前列腺活检是阴性的， 其中一个是假阴性。RRI的研究表明，光谱- 所提出的系统的参数成像（SPI）方法可以提高 前列腺癌检测率提高50%，可额外检测15万例 癌症每年在美国，减少重复活检的需要，并允许 及早开始治疗。由于RRI的研究是在 研究环境，实现SPI对前列腺的明显潜力- 癌症检测需要1）在临床试验中验证SPI方法， 使用实时成像系统的设置，以及2）广泛的临床 传播。拟议的SBIR研究旨在采取这些步骤， 开发一种实时成像系统， 前列腺的可疑区域。这种颜色编码将基于 超声射频回波信号的频谱分析我们预计活检 通过增加灵敏度可以显著提高功效， 这种活检引导图像的特异性。第一阶段的工作 将寻求1）确定实时的最佳实施方法 组织型成像，2）SPI技术与“主机”B模式接口 仪器，3）制定PI系统规范，4）计划第二阶段 原型构建工作。 拟议的商业应用： 仅在美国，每年就有超过1，000，000例前列腺活检。 大约70%是阴性的，超过一半的阴性活检是阴性的。 错误。重复活检的阳性率几乎相同 作为初始活检。不必要的重复活检和遗漏的癌症 巨大的成本和患者风险。建议的SPI方法出现 能够将癌症检测提高50%，这将使SPI非常 商业上有吸引力，医学上有价值。