Bedside ultrasound system for 3D guidance of bone marrow aspiration and biopsy procedures

用于骨髓抽吸和活检程序的 3D 引导的床边超声系统

基本信息

批准号：
10153741
负责人：
Frank William Mauldin
金额：
$ 82.92万
依托单位：
RIVANNA MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-05-01 至 2022-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10153741
关键词：
3-Dimensional 3D ultrasound Advanced Development Algorithms Anatomy Anxiety Biopsy Biopsy Specimen Bone Marrow Bone Marrow Aspiration Bone Surface Bone marrow biopsy Cadaver Clinic Clinical Clinical Trials Consumption Core Biopsy Data Detection Devices Diagnosis Diagnostic Diagnostic Errors Diagnostic radiologic examination Dimensions Direct Costs Elderly Ensure Exhibits Exposure to Failure Funding Goals Gold Growth Guidelines Hand Health Care Costs Health care facility Healthcare Healthcare Systems Hematologic Neoplasms Hematological Disease Hematologist Hematology Human Human Volunteers Image Image Analysis Imaging technology In Vitro Individual Interventional radiology Intuition Ionizing radiation Knowledge Learning Length Manuals Medical Medical Device Modeling Monitor Morphologic artifacts Needles Obesity Oncologist Oncology Oncology Group Palpation Pathology Patients Phase Physicians&apos Offices Plant Roots Positioning Attribute Privatization Procedures Provider Puncture biopsy Real-Time Systems Recommendation Reporting Resources Retrieval Sensitivity and Specificity Serious Adverse Event Services Site Specimen Surface System Techniques Technology Testing Three-Dimensional Image Time Trephine Biopsy Ultrasonography Validation Virginia Visualization Work World Health Organization arm automated algorithm base blind bone bone imaging bone quality commercial application cost cost effective design diagnosis standard human imaging image guided image guided intervention image processing imaging capabilities imaging probe imaging study imaging system improved improved outcome innovation miniaturize patient population patient safety point of care portability pre-clinical prevent procedure cost prototype reconstruction response stem success technological innovation technology development

项目摘要

PROJECT SUMMARY/ABSTRACT Bone marrow and trephine biopsy (BMTB) is the gold standard for diagnosing and monitoring hematological disorders and malignancies. Although BMTB procedures rarely cause serious adverse events, the number of non-diagnostic biopsies should be minimized because repeated testing delays diagnosis and treatment, consumes additional healthcare resources, and causes unnecessary patient anxiety and discomfort. World Health Organization guidelines recommend that bone marrow biopsy cores exceed 1.5 cm in length, however multiple clinical trials have reported that 20 – 50 % of core lengths are ≤ 1.0 cm, suggesting that these clinical recommendations are not regularly met. This conclusion is further supported by the finding that between 5 – 25 % of BMTB specimens are deemed non-diagnostic by pathology, often necessitating a repeat BMTB procedure, referral for radiographic guidance of the BMTB procedure, or ultimately resulting in an ambiguous or false negative diagnosis. The goal of this Phase II project is to finalize the design and fabrication of a clinical-trial-ready imaging system (Accuro 3S) for real-time 3D image guidance of bone marrow trephine biopsy procedures at the bedside. The key technological innovations of this project include: (i) the design of a miniaturized 3D ultrasound imaging probe, (ii) the development of advanced bone-specific imaging and 3D rendering technologies for generating volumetric reconstructions of the patient's iliac crest in real-time, and (iii) the implementation of an image processing algorithm that automatically detects the posterior iliac crest and assists with automated needle guidance to the target anatomy to facilitate biopsy acquisition. The intent of these technologies is to provide an intuitive visualization of the iliac crest and to avoid difficulties associated with ultrasound image interpretation when conducting an image-guided interventional procedure. Core technologies will be developed and tested via extensive in vitro imaging studies of anatomically correct phantoms prior to pre-clinical validation in a human cadaveric specimens. The impact of the proposed solution is a significant improvement in BMTB success rates and a reduced rate of referral for radiographic guidance. These effects are expected to reduce delays in BMTB acquisition, reduce patient exposure to ionizing radiation, and reduce costs due to the need for fewer repeat biopsies and fewer referrals for radiographic guidance. Together, the annual costs due to referral for radiographic guidance, repeat BMTB procedures, and costs stemming from diagnostic errors exceed $480M/yr. For these reasons, BMTB specimen retrieval at the bedside in the hematology clinic is the preferred biopsy technique. The technological solutions proposed in this Phase II application seek to enable improved outcomes of BMTB procedures performed at the bedside. Finally, the total US market size for this device is estimated to be $230M/yr, supporting the commercial viability of the proposed technology development efforts.

项目概要/摘要骨髓和环钻活检 (BMTB) 是诊断和监测的金标准尽管 BMTB 手术很少引起严重的不良事件，应尽量减少非诊断性活检的数量，因为重复检测会延误诊断和治疗，消耗额外的医疗资源，并导致患者不必要的焦虑和不适。世界卫生组织指南建议骨髓活检芯长度超过1.5厘米，然而，多项临床试验报告称，20-50% 的芯长度≤ 1.0 cm，这表明这些临床建议并未定期得到满足，这一结论得到了以下发现的进一步支持。 5 – 25% 的 BMTB 标本被病理学认为无法诊断，通常需要重复 BMTB 程序、转介 BMTB 程序的放射线照相指导，或最终导致诊断不明确或假阴性。该第二阶段项目的目标是完成临床试验成像的设计和制造系统 (Accuro 3S)，用于在骨髓环钻活检过程中进行实时 3D 图像引导该项目的关键技术创新包括：（i）小型化3D设计。超声成像探头，(ii) 先进骨特异性成像和 3D 渲染的发展用于实时生成患者髂嵴体积重建的技术，以及 (iii) 实现自动检测髂后嵴并辅助的图像处理算法自动引导针引导至目标解剖结构，以促进活检采集。技术的目的是提供髂嵴的直观可视化并避免与相关的困难进行图像引导介入手术时的超声图像解读核心技术。将通过对解剖学上正确的模型进行广泛的体外成像研究来开发和测试在人类尸体标本中进行临床前验证。所提出的解决方案的影响是显着提高 BMTB 成功率并减少这些影响预计会减少 BMTB 采集的延迟，减少患者对电离辐射的暴露，并由于需要更少的重复活检而降低成本放射照相指导转诊次数减少总而言之，每年因放射照相指导转诊而产生的费用，重复 BMTB 程序，诊断错误造成的成本超过每年 4.8 亿美元。在血液学诊所的床边取出 BMTB 标本是首选的活检技术。第二阶段申请中提出的技术解决方案旨在改善 BMTB 的结果最后，该设备的美国市场总规模估计为：每年 2.3 亿美元，支持拟议技术开发工作的商业可行性。