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Optical and electromagnetic tracking guidance for hepatic interventions

肝脏干预的光学和电磁跟踪指导

基本信息

批准号：
10226852
负责人：
Umar Mahmood
金额：
$ 22.54万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-03-02 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10226852
关键词：
Benign Biopsy Biopsy Specimen Clinical Clinical Trials Collaborations Colorectal Data Set Detection Development Devices Diagnostic Electromagnetics Ensure Evaluation Extramural Activities Feedback Fluorochrome Gold Hepatic Human Image Imaging Device Imaging Techniques Indocyanine Green Intervention Interventional radiology Kinetics Lesion Light Liver neoplasms Location Logistics Malignant - descriptor Measurement Methods Motion Needle biopsy procedure Needles Neoplasm Metastasis Oncology Optics Pathologic Pathology Patient Care Patients Pre-Clinical Model Primary carcinoma of the liver cells Procedures Retrospective Studies Sampling Signal Transduction Site System Techniques Technology Testing Time Tissues Tumor Markers United States United States National Institutes of Health Visualization analog clinical center data streams diagnostic accuracy experience first-in-human imaging agent improved in vivo new technology optical imaging phantom model point of care synergism tissue phantom tumor

项目摘要

Abstract Percutaneous sampling of focal hepatic lesions is a cornerstone in the management of patients with hepatic pathology. The advent of advanced imaging has improved the sensitivity for lesion detection; however small lesions often lack specific features to allow for reliable non-invasive characterization, resulting in an increase in the number of biopsies for such hepatic lesions over the past decade. Accuracy of a focal hepatic biopsy is essential, as a false negative biopsy can have a devastating impact on a patient's treatment. In a retrospective study, up to 45% of small hepatic lesions were insufficiently visualized with the biopsy needle in place and had a false negative rate, defined as the number of patients with benign biopsies who were subsequently found to have malignant lesions at the attempted site of biopsy, of 37% for hepatocellular carcinomas. Thus, there is a significant need for improved methods for accurately sampling hepatic lesions. Recently, it was discovered that indocyanine green (ICG), a clinically approved near infrared fluorochrome, accumulates in hepatic foci such as hepatocellular carcinomas and hepatic colorectal metastases, resulting in a high target to background ratio when visualized using near infrared light. The PI of this proposal has led the first human experience, at MGH, combining optical imaging using ICG with interventional radiology percutaneous hepatic sampling. Independently, the intramural PI of this proposal has pioneered the development and clinical trials of electromagnetic (EM) navigation techniques for interventional radiology guided percutaneous sampling at the NIH Clinical Center – Center for Interventional Oncology (CIO). We propose to build upon a longstanding collaboration between the extramural and intramural PIs, and combine these two intrinsically synergistic, recent advances in the field of interventional radiology. The EM guided devices navigate the biopsy needle close to imaged lesions and can be thought of as far-field optimized; the optical imaging devices provide real- time feedback to assess if needle cores are appropriately located within small hepatic tumors and can be thought of as near-field devices. This first-in-man assessment of the new, proposed intramural-extramural jointly developed device will take place at the NIH CC-CIO. This jointly created and iteratively optimized device will help to improve patient care through improved diagnostic accuracy.

摘要肝局灶性病变的经皮取样是治疗肝硬化患者的基石。病理先进成像技术的出现提高了病变检测的灵敏度;无论病变有多小，病变通常缺乏允许可靠的非侵入性表征的特定特征，导致在过去十年中，此类肝脏病变的活组织检查次数。局灶性肝活检的准确性是这是至关重要的，因为假阴性活检可能对患者的治疗产生破坏性影响。回顾性在一项研究中，高达45%的肝脏小病变在活检针到位时无法充分可视化，假阴性率，定义为随后发现患有良性活检的患者数量在尝试活检的部位有恶性病变，37%为肝细胞癌。因此，有一个对用于精确地对肝损伤取样的改进方法的显著需求。最近发现，吲哚菁绿色（ICG）是一种临床批准的近红外荧光染料，在肝病灶中蓄积，肝细胞癌和肝结直肠转移，导致高靶背景比当使用近红外光可视化时。这个提议的PI在MGH领导了第一次人类体验，将使用ICG的光学成像与介入放射学经皮肝取样相结合。独立地，该提议的内部PI开创了以下药物的开发和临床试验：电磁（EM）导航技术，用于介入放射学引导的经皮采样， NIH临床中心-介入肿瘤学中心（CIO）。我们建议建立在一个长期的内外PI之间的协作，并将这两种内在协同作用联合收割机结合起来，介入放射学领域的最新进展。EM引导器械导航活检针接近成像的病变，并且可以被认为是远场优化的;光学成像设备提供真实的时间反馈，以评估针芯是否适当地位于小肝肿瘤内，被认为是近场设备。这是首次对新的、拟议的校内-校外联合开发的设备将在NIH CC-CIO进行。这个共同创建并迭代优化的设备将有助于通过提高诊断准确性来改善患者护理。