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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.

项目总结/文摘