Portable Imaging Device for Prostate Cancer Detection

用于前列腺癌检测的便携式成像设备

• 批准号: 7479828
• 负责人: Armen Sarvazyan
• 金额: $ 100万
• 依托单位: ARTANN LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-08-01 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7479828
• 关键词: 3-Dimensional; Adult; Algorithms; Bladder; Breast Cancer Detection; Calibration; Cancer Detection; Certification; Characteristics; Clinical Research; Color; Commit; Complement; Computer software; Condition; Data; Data Analyses; Detection; Development; Devices; Diagnostic; Disease Progression; Documentation; Effectiveness; Electronics; End Point; Engineering; Ensure; Freezing; Gland; Goals; Grant; Guanosine Monophosphate; Image; Imagery; Imaging Device; Industry; Internet; Laboratories; Lead; Legal patent; Lesion; Location; Malignant neoplasm of prostate; Marketing; Mechanics; Medical; Medical Device; Medical center; Metric; Modeling; Monitor; Motion; New Brunswick; Nodule; Operative Surgical Procedures; Palpable; Performance; Preparation; Principal Investigator; Property; Prostate; Recording of previous events; Records; Reporting; Research; Resources; Safety; Screening for Prostate Cancer; Screening procedure; Staging; Stress; Structure; System; Tactile; Technology; Testing; Tetradecanoylphorbol Acetate; Three-Dimensional Image; Three-Dimensional Imaging; Time; TimeLine; Tissues; United States Food and Drug Administration; United States National Institutes of Health; Validation; Wireless Technology; Wood material; commercialization; concept; cost; cost effective; data acquisition; design; digital; laptop; male; prototype; reconstruction; research study; sensor; size; software development; success; tool; touchscreen; validation studies

DESCRIPTION (provided by applicant): The long-term goal of the project is to bring to the market a new tool for prostate cancer screening, the Prostate Mechanical Imager (PMI), which provides real time 3-D reconstruction of prostate capturing its geometrical and mechanical characteristics and aids in detecting tissue abnormalities. The current PMI prototype has undergone several progressions of hardware and software development leading to the final device concept validated in model experiments and in clinical studies which have yielded promising results. ProUroScanTM is the first PMI commercial device to be developed, clinically tested and submitted for FDA approval in the course of the proposed project. Digital records obtained by ProUroScanTM could be used to document palpable prostate abnormalities and to monitor disease progression over time. The ProUroScanTM will include a transrectal probe comprising force sensor arrays and a motion tracking system, a compact electronic unit with single electronic board powered through USB port from a laptop with touch screen capability and a wireless color printer. As a separate component, an automatic calibration setup for tactile sensor testing, tuning and calibration will be designed and built. Specific aims of the proposed project include PMI hardware and software refinements. The hardware development will include several technological improvements in the PMI transrectal probe and data acquisition board. Software for prostate 3-D real-time reconstruction and nodule detection will be refined and validated. Substantial amount of effort will be committed to assure the activities and resulting design of the PMI development comply with regulatory requirements. A key focus of pre-commercialization engineering will be on completing the design history file, verification, validation and safety certification testing. Two-stage clinical studies will be conducted at the Robert Wood Johnson Medical Center (New Brunswick, NJ) and at VA Medical Center (Minneapolis, MN) to document system safety and efficacy. The focal point of all proposed activities and the endpoint of the grant will be preparation and submission of the PMA application for the FDA approval of PMI. The core partnership was established between Artann and ProUroCare, publicly traded medical device company, to ensure commercialization success of the PMI. ProUroCare has committed necessary financial and managerial resources for regulatory clearance and commercialization of the PMI technology to complement NIH support of the project. There is a $50 billion prostate-related market with estimated 40 - 60 milion adult males suffering from one or more prostate conditions. Industry analysts believe that only 10 - 15% of incidents are reported, stressing the urgent need for new screening technologies. The goal of this project is to develop ProUroScanTM, a cost- effective, portable and easy-to-use imaging device for detecting and documenting palpable prostate abnormalities and monitoring disease progression over time.

描述（由申请人提供）：该项目的长期目标是将前列腺癌筛查的新工具，前列腺机械成像仪（PMI），该工具提供了实时的3-D重建，可捕获其几何和机械特征，并在检测组织异常方面捕获其几何特征和辅助。当前的PMI原型经历了硬件和软件开发的几个进程，导致在模型实验和临床研究中验证的最终设备概念，这些概念产生了有希望的结果。 Prourscantm是第一个在拟议项目的过程中开发，临床测试和提交FDA批准的PMI商业设备。 Prourscantm获得的数字记录可用于记录可触及的前列腺异常，并随着时间的流逝监测疾病的进展。 proursoscantm将包括一个包括力传感器阵列的转直肠探针和一个运动跟踪系统，一个紧凑型电子设备，具有单个电子板，从笔记本电脑通过触摸屏功能和无线颜色打印机的单个电子板通过USB端口进行了动力。作为一个单独的组件，将设计和构建用于触觉传感器测试，调整和校准的自动校准设置。拟议项目的具体目的包括PMI硬件和软件改进。硬件开发将包括PMI转直肠探针和数据采集委员会的一些技术改进。前列腺3-D实时重建和结节检测的软件将得到完善和验证。将承诺要确保PMI开发的活动和由此产生的设计符合法规要求，将承诺大量的努力。商业化工程的重点将是完成设计历史记录文件，验证，验证和安全认证测试。两阶段的临床研究将在罗伯特·伍德·约翰逊医疗中心（新泽西州新不伦瑞克省）和弗吉尼亚州医疗中心（明尼苏达州明尼阿波利斯）进行，以记录系统的安全和效力。所有拟议活动的焦点和赠款的终点将是PMA批准PMA申请的准备和提交。核心合作伙伴关系建立在Artann和Prourocare（公开交易的医疗设备公司）之间，以确保PMI的商业化成功。 Prourocare已承诺为PMI技术的监管清算和商业化提供必要的财务和管理资源，以补充NIH对该项目的支持。有500亿美元的前列腺相关市场，估计有40至6000万人患有一个或多个前列腺状况的成年男性。行业分析师认为，仅报告了10-15％的事件，这强调了对新筛查技术的迫切需求。该项目的目的是开发Prourscantm，这是一种具有成本效益，便携式且易于使用的成像装置，用于检测和记录可触及的前列腺异常，并随着时间的推移监测疾病的发展。