Optical and electromagnetic tracking guidance for hepatic interventions

肝脏干预的光学和电磁跟踪指导

• 批准号: 9260276
• 负责人: Umar Mahmood
• 金额: $ 42.2万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-02 至 2021-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9260276
• 关键词: Benign; Biopsy; Biopsy Specimen; Clinical; Clinical Trials; Collaborations; Colorectal; Data; Data Set; Detection; Development; Devices; Diagnostic; Electromagnetics; Ensure; Evaluation; Extramural Activities; Feedback; Fluorochrome; Gold; Hepatic; Human; Image; Imagery; 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; Optics; Pathologic; Pathology; Patient Care; Patients; Pre-Clinical Model; Primary carcinoma of the liver cells; Procedures; Retrospective Studies; Sampling; Signal Transduction; Site; Stream; System; Techniques; Technology; Testing; Time; Tissues; Tumor Markers; United States; United States National Institutes of Health; analog; diagnostic accuracy; experience; imaging agent; improved; in vivo; man; new technology; oncology; optical imaging; phantom model; point of care; synergism; tissue phantom; tumor

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 局灶性肝脏病变的经皮取样是肝病患者治疗的基石 病理。先进成像技术的出现提高了病变检测的灵敏度；不管多么小 病变通常缺乏特定的特征来进行可靠的非侵入性表征，导致 过去十年中此类肝脏病变的活检数量。局灶性肝活检的准确性为 至关重要，因为假阴性活检可能对患者的治疗产生毁灭性影响。在回顾中 研究表明，高达 45% 的小肝脏病变在活检针就位时无法充分显现，并且 假阴性率，定义为随后发现良性活检的患者数量 在尝试活检的部位有恶性病变，其中 37% 为肝细胞癌。因此，有一个 迫切需要改进对肝脏病变进行准确采样的方法。近日，人们发现， 吲哚菁绿 (ICG) 是一种临床批准的近红外荧光染料，可积聚在肝脏病灶中，例如 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。该提案的 PI 在 MGH 领导了首次人类体验， 将使用 ICG 的光学成像与介入放射学经皮肝脏采样相结合。 独立地，该提案的校内 PI 开创了以下药物的开发和临床试验： 用于介入放射学引导经皮采样的电磁 (EM) 导航技术 NIH 临床中心 – 介入肿瘤学中心 (CIO)。我们建议建立在长期 校外和校内 PI 之间的合作，并将这两个本质上的协同作用结合起来， 介入放射学领域的最新进展。电磁引导设备引导活检针 接近成像病灶，可被视为远场优化；光学成像设备提供真实 时间反馈以评估针芯是否正确定位在小肝肿瘤内并且可以 被认为是近场设备。这是对新提议的壁内-壁外的首次人体评估 联合开发的设备将在 NIH CC-CIO 进行。这个共同打造并迭代优化的设备 将通过提高诊断准确性来帮助改善患者护理。