Development of radiological clips having ultrasound identification

具有超声识别功能的放射线夹的研制

• 批准号: 10365578
• 负责人: Michael L. Oelze
• 金额: $ 22.21万
• 依托单位: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10365578
• 关键词: Adoption; Appearance; Automobile Driving; Back; Benign; Biopsy; Breast; Cancerous; Clinic; Clinical; Clip; Code; Development; Devices; Diagnostic; Diagnostic Imaging; Disease; Effectiveness; Goals; Image; Label; Lesion; Location; Manufacturer Name; Medical; Medicine; Metals; Metastatic Neoplasm to Lymph Nodes; Modality; Modeling; Modernization; Monitor; Neoadjuvant Therapy; Operative Surgical Procedures; Oryctolagus cuniculus; Physicians; Physiologic pulse; Positive Lymph Node; Problem Solving; Process; Property; Protocols documentation; Radiology Specialty; Scanning; Shapes; Signal Transduction; Source; Specificity; Surface; Surgeon; System; Technology; Testing; Texture; Time; Tissues; Tumor stage; Ultrasonics; Ultrasonography; Visualization; Water; biomaterial compatibility; breast lesion; cancer imaging; cancer therapy; chemotherapy; clinically significant; contrast imaging; design; follow-up; imaging capabilities; imaging modality; imaging probe; imaging study; improved; in vivo; lymph nodes; malignant breast neoplasm; migration; new technology; novel; portability; real-time images; tool; treatment response; tumor

PROJECT SUMMARY Radiological markers or clips are an important tool for diagnostic imaging because they can be placed in the body allowing identification of specific tissues over time and over multiple scans. For neoadjuvant chemotherapy (NAC) in breast cancer, imaging is used to stage tumor size, to identify possible lymph nodes for metastases, to guide biopsy of both tumors, lesions and lymph nodes and to monitor the size and appearance of tumors over time. Between the initial identification of a tumor and positive lymph nodes, chemotherapy application and surgery, several months can pass. Before NAC, tumor, lesions and suspicious lymph nodes are often marked with radiological clips in order to be able to re-identify them before surgery. This is necessary because the appearance of the tumors and lymph nodes can change or even normalize over the course of NAC. In recent years, a multitude of clips have been designed and manufactured with the goal of providing better image contrast and identification under real-time imaging with modalities such as ultrasound. Ultrasound is preferred in these applications because it is safe, real time, portable and can be used at the bedside. Initially it was thought that simple clip designs made from metal would provide sufficiently high contrast for ultrasound that locating the clips in B-mode ultrasound would be straightforward. However, in practice, identification of radiological clips can be difficult as multiple bright scatterers in the imaging field can look in appearance similar to the signal from a clip. As a result, over time new clips have been developed that have a variety of shapes and sizes, different surface textures and compound material properties. While manufacturers have asserted that these clip designs solve the problem of visualization on ultrasound B-mode and {allow identification of different tissues}, these claims have not been realized in practice. The problem of proper visualization is still significant and these clips are not always identifiable especially on follow on imaging studies after initial clip placement. Therefore, we propose to develop a new type of radiological clip that can provide the ability to be visualized by ultrasonic imaging but also to identify the specific clip in the tissue. The new clip consists of a small biocompatible ultrasonic source and driving circuit that detects an ultrasonic imaging pulse. The ultrasonic imaging pulse then triggers the circuit, comprised of several small oscillators, to drive the ultrasonic source to emit a specific encoded ultrasonic signal. The ultrasonic signal will provide a unique identification code allowing the clip to not only be clearly visualized and localized with specificity by ultrasound, but also to identify the specific clip, i.e., ultrasound identification (USID). {Our clip visibility does not depend on the echogenicity of the clip but on the unique clip signal that is emitted and processed}. To develop these radiological clips we propose two specific aims. The first aim is to design, build and test USID radiological clips capable of providing unique ID tags. The second aim is to demonstrate the capabilities of a stand-alone version of the radiological clips in tissue- mimicking phantoms and {in vivo}.

项目概要 放射标记或夹子是诊断成像的重要工具，因为它们可以放置在 身体允许随着时间的推移和多次扫描识别特定的组织。用于新辅助化疗 (NAC) 在乳腺癌中，成像用于对肿瘤大小进行分期，识别可能发生转移的淋巴结， 指导肿瘤、病变和淋巴结的活检，并监测肿瘤的大小和外观 时间。在肿瘤和阳性淋巴结的初步鉴定、化疗的应用和 手术，几个月可以过去。在 NAC 之前，通常会标记肿瘤、病变和可疑淋巴结 使用放射夹，以便能够在手术前重新识别它们。这是必要的，因为 在 NAC 过程中，肿瘤和淋巴结的外观可能会发生变化甚至正常化。 近年来，设计和制造了大量的夹子，目的是提供更好的 超声波等实时成像下的图像对比度和识别。超声波是 在这些应用中是首选，因为它安全、实时、便携并且可以在床边使用。最初它 人们认为由金属制成的简单夹子设计将为超声波提供足够高的对比度 在 B 型超声中定位夹子会很简单。但在实践中，识别 放射剪辑可能很困难，因为成像场中的多个明亮散射体看起来相似 来自剪辑的信号。结果，随着时间的推移，新的夹子被开发出来，具有各种形状和 尺寸、不同的表面纹理和复合材料特性。虽然制造商声称 这些夹子设计解决了超声 B 型的可视化问题，并且{允许识别不同的 组织}，这些主张在实践中尚未实现。正确可视化的问题仍然很重要 并且这些夹子并不总是可识别的，特别是在初始夹子放置后的后续成像研究中。 因此，我们建议开发一种新型放射夹，能够提供可视化的能力 通过超声波成像还可以识别组织中的特定夹子。新剪辑由一个小 生物相容性超声源和检测超声成像脉冲的驱动电路。超声波 然后成像脉冲触发由几个小型振荡器组成的电路，以驱动超声波源 发射特定编码的超声波信号。超声波信号将提供唯一的识别码，允许 该夹子不仅可以通过超声波清晰地可视化和特异性定位，而且还可以识别特定的 剪辑，即超声识别（USID）。 {我们的剪辑可见性并不取决于剪辑的回声性，而是取决于 发射和处理的独特剪辑信号}。为了开发这些放射剪辑，我们提出了两种建议 具体目标。第一个目标是设计、构建和测试能够提供唯一 ID 的 USID 放射夹 标签。第二个目标是展示组织中放射夹的独立版本的功能 模仿幻影和{体内}。