REAL-TIME ULTRASONIC TISSUE IMAGING FOR PROSTATE CANCER

Spectrasonics Imaging，Inc.提出了与滨江研究所（RRI）合作的第二阶段工作，以开发一种实时超声成像系统，用于指示前列腺可疑癌症的区域。 该系统产生的实时图像将能够更好地指导针活检。 目前超声引导活检对前列腺癌的敏感性和特异性不令人满意。因此，绝大多数前列腺活检是阴性的，导致不可接受的高假阴性率。RRI的研究表明，所提出的系统的光谱参数成像（SPI）方法可以将前列腺癌的检测提高50%，这可以在美国每年检测15万个额外的癌症，减少重复活检的需要，并允许更早地开始治疗。 拟议的SBIR研究旨在开发一种实时成像系统，该系统使用颜色编码来描绘前列腺的可疑区域。 这种颜色编码将基于超声波射频回波信号的频谱分析。 我们预计，活检的效率可以显着提高通过增加这种活检引导图像的灵敏度和特异性。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假的。 重复活检的阳性率几乎与初次活检相同，不必要的重复活检和漏诊会增加患者的风险和费用。 所提出的SPI方法似乎能够将癌症检测提高50%，这应该证明具有临床意义和商业价值。

Spectrasonics Imaging, Inc. proposes a Phase II effort in collaboration with Riverside Research Institute (RRI) to develop a real-time ultrasonic, imaging 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, resulting in an unacceptably high false negative rate. Studies by RRI suggest that the Spectral-Parameter Imaging (SPI) methods underlying the proposed system can improve detection of prostate cancer by 50 percent, which could detect 150,000 additional cancers annually in the US, reduce the need for repeat biopsies, and permit earlier initiation of treatment. The proposed SBIR study seeks to develop 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. PROPOSED COMMERCIAL APPLICATION Over 1,000,000 prostate biopsies occur annually in the U.S. alone. Approximately 70 percent are negative, and over half of the negative biopsies are false. Repeat biopsies have almost the same incidence of positive biopsies as the initail exam. Unnecessary repeat biopsies and missed cancers impose an enromous dollar cost and patient risk. The proposed SPI methods appear capable of improving cancer detection by 50 percent which should prove clinically significant and commercially valuable.