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.

抽象的局灶性肝损伤的经皮取样是肝脏患者治疗的基石病理。高级成像的进步提高了病变检测的敏感性。但是很小病变通常缺乏特定的特征来允许可靠的非侵入性表征，从而增加在过去十年中，这种肝病变的活检数量。局灶性肝活检的准确性是必不可少的，因为假阴性活检可能会对患者的治疗产生毁灭性影响。回顾性研究，多达45％的小肝病病变不足以用活检针对适当假阴性率，定义为良性活检的患者数量，后来被发现肝细胞癌的活检部位有恶性病变，为37％。那有一个非常需要改进的方法，以准确采样肝病变。最近，发现氨基苯胺绿色（ICG）是一种临床批准的近乎感染的荧光色素，积累在肝灶中，例如肝细胞癌和肝结直肠转移，导致较高的靶标比率当使用近红外光看到时。该提议的PI领导了MGH的第一个人类经验使用ICG与介入放射学经皮肝样采样结合光学成像。独立地，该提案的壁内PI率先开发和临床试验电磁（EM）导航技术，用于介入放射学的导航技术在介入 NIH临床中心 - 介入肿瘤学中心（CIO）。我们建议建立一个长期的壁外和壁内PI之间的协作，并将这两个本质上的协同作用结合在一起介入放射学领域的最新进展。 EM引导设备导航活检针头接近成像的病变，可以考虑到远场优化；光学成像设备提供了实现 - 时间反馈以评估针芯是否适当地位于小肝肿瘤中，可以是被认为是近场设备。对新的，拟议的壁内 - 术中的首次评估共同开发的设备将在NIH CC-CIO进行。这个共同创建并迭代优化的设备通过提高诊断准确性，将有助于改善患者护理。