Development of radiological clips having ultrasound identification

项目摘要 放射性标记物或夹子是用于诊断成像的重要工具，因为它们可以被放置在 身体允许随着时间和多次扫描识别特定组织。新辅助化疗 (NAC)在乳腺癌中，成像用于对肿瘤大小进行分期，以识别可能的转移淋巴结， 引导肿瘤、病变和淋巴结的活检，并监测肿瘤的大小和外观， 时间在最初确定肿瘤和阳性淋巴结之间，化疗的应用和 手术，几个月可以通过。NAC前，肿瘤、病变和可疑淋巴结常被标记 用放射线夹来固定，以便在手术前重新识别它们。这是必要的，因为 肿瘤和淋巴结的外观可以在NAC的过程中改变或甚至正常化。 近年来，已经设计和制造了大量的夹子，其目的是提供更好的性能。 图像对比度和在诸如超声的模态的实时成像下的识别。超声是 在这些应用中是优选的，因为它是安全的、真实的时间的、便携的并且可以在床边使用。最初它 认为由金属制成的简单夹子设计将为超声提供足够高的对比度， 在B型超声中定位夹子将是简单的。然而，在实践中， 由于成像场中的多个明亮散射体在外观上可能看起来类似 一个夹子的信号。因此，随着时间的推移，已经开发出具有各种形状的新夹子， 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模式上的可视化问题 组织}，这些要求在实践中尚未实现。适当的可视化问题仍然很重要 并且这些夹子并不总是可识别的，特别是在最初夹子放置之后的后续成像研究中。 因此，我们建议开发一种新型的放射线夹，可以提供可视化的能力， 通过超声波成像，还可以识别组织中的特定夹子。新剪辑由一个小的 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振荡器组成的电路，以驱动超声源， 发射特定的编码超声波信号。超声波信号将提供唯一的识别码， 该夹不仅可以通过超声清晰地可视化和特异性地定位，而且还可以识别特定的 夹子，即，超声识别（USID）。{Our夹子的可见性不取决于夹子的回声反射性， 在发射和处理的唯一限幅信号上}。为了开发这些放射性剪辑，我们提出了两个 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放射线夹 标签.第二个目的是证明放射线夹的独立版本在组织中的能力- 模拟幻影和体内。

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}.