Dual Mode, Hand-held Intraoperative Imager

描述（由申请人提供）：放射性核素引导术中探头提高了组织活检的特异性，实现了最小切口，减少了住院患者的使用，并有助于改善患者的恢复。目前，市场上的大多数此类探头是非成像的，并且不提供所调查区域的辅助信息，例如恶性组织的清晰描绘。我们的目标是开发一种革命性的新型成像探头，成像Beta探头TM（IBPTM），旨在通过感应伽马射线快速定位病变，然后对短程β粒子或正电子进行实时高灵敏度成像。这种符合人体工程学设计的探头体积小，易于在手术过程中使用，并且通过RMD最近开发的位置敏感固态光电倍增管（PS-SSPM）和混合闪烁技术成为可能。探头将向外科医生提供来自调查区域的发射的连续实时音频和/或视频反馈，以便快速准确地描绘和精确切除病变，同时最大限度地减少周围健康组织的牺牲。在切除可疑组织后，IBPTM将允许外科医生检查肿瘤床和边缘是否有任何剩余的癌组织和癌前组织、细小肿瘤或其他组织（例如，子宫内膜）能够摄取所施用的示踪剂，否则会被背景辐射遮蔽。 我们追求我们提出的成像Beta探针设计的动机是，它将提供几十年来探针技术的第一个根本性变化，最重要的是， 术中和外部诊断探针的临床能力的显著改进和扩展。这项技术的发展为外科医生提供了一种成像工具，可以在术中检测PET阳性病变，这将提高他们利用活检材料确认PET扫描提供的数据的能力。此外，这些工具可以允许外科医生对小病变进行PET引导的探查和治疗性切除，否则这些小病变将无法通过常规探查发现或通过化疗或放疗的苛刻经验方案治疗。 公共卫生相关性：放射性核素引导的术中探针增加了组织活检的特异性，实现了最小进入切口，减少了住院患者的医院利用率，并有助于改善患者的恢复。我们的目标是开发一种革命性的新型成像探头，成像Beta探头TM（IBPTM），旨在通过感应伽马射线快速定位病变，然后对短程β粒子或正电子进行实时高灵敏度成像。这项技术的发展为外科医生提供了一种成像工具，可以在术中检测PET阳性病变，这将提高他们利用活检材料确认PET扫描提供的数据的能力。

DESCRIPTION (provided by applicant): Radionuclide-guided intraoperative probes increase the specificity of tissue biopsies, enable minimal- access incisions, reduce inpatient hospital utilization, and contribute to improved patient recovery. At present, most such probes on the market are non-imaging, and provide no ancillary information of surveyed areas, such as clear delineations of malignant tissues. Our goal is to develop a revolutionary new imaging probe, the Imaging Beta ProbeTM (IBPTM), intended for rapid localization of lesions by sensing gamma rays, followed by real-time high-sensitivity imaging of short-range beta particles or positrons. This ergonomically designed probe will be small and easy to use during surgery, and is made possible by the recent development of position- sensitive solid-state photomultiplier (PS-SSPM) and hybrid scintillation technologies at RMD. The probe will provide continuous real-time audio and/or video feedback of emissions from surveyed areas to the surgeon for rapid and accurate delineation and precise excision of lesions, with minimal sacrifice of surrounding healthy tissue. After excision of suspect tissue, the IBPTM will allow the surgeon to check the tumor bed and margins for any remaining cancerous and pre-cancerous tissue, fine tumors or other tissues (e.g., endometrial) capable of uptake of the administered tracer, that are otherwise obscured by background radiation. Our motivation in pursuing our proposed Imaging Beta Probe design is that it will provide the first radical change in probe technology in decades and, most importantly, significant improvement in and broadening of the clinical capabilities of intraoperative and external diagnostic probes. Development of this technology provides an imaging tool for surgeons to detect PET-positive lesions intraoperatively, which will advance their ability to confirm data provided by PET scans with biopsy material. Furthermore, these tools may allow a surgeon to perform a PET-guided exploration and therapeutic excision of a small lesion that would otherwise be undiscovered by conventional exploration or treated by a harsh empiric regimen of chemotherapy or radiation. PUBLIC HEALTH RELEVANCE: Radionuclide-guided intraoperative probes increase the specificity of tissue biopsies, enable minimal- access incisions, reduce inpatient hospital utilization, and contribute to improved patient recovery. Our goal is to develop a revolutionary new imaging probe, the Imaging Beta ProbeTM (IBPTM), intended for rapid localization of lesions by sensing gamma rays, followed by real-time high-sensitivity imaging of short-range beta particles or positrons. Development of this technology provides an imaging tool for surgeons to detect PET-positive lesions intraoperatively, which will advance their ability to confirm data provided by PET scans with biopsy material.