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: 10691780
• 负责人: Bradford Wood
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10691780
• 关键词: Abdomen; Biopsy; Cancerous; Carcinoma; Clinical; Clinical Trials; Computer software; Core Biopsy; Custom; Cytology; Detection; Devices; Diagnosis; Electromagnetics; Elements; Endoscopy; Enhancing Lesion; Feedback; Fluorescence; Goals; Hepatic; Human; Image; Indocyanine Green; Institutional Review Boards; Intervention; Intravenous; Lesion; Liver; Liver diseases; Liver neoplasms; Location; Metastatic Neoplasm to the Liver; Methods; Minimal Risk Study; Modeling; Needle biopsy procedure; Needles; Nodule; Optics; Patients; Pharmaceutical Preparations; Point-of-Care Systems; Primary carcinoma of the liver cells; Regulatory Pathway; Sampling; Signal Transduction; Specific qualifier value; Specimen; System; Technology; Time; Tissues; United States National Institutes of Health; Validation; Visualization; Woodchuck; Work; clinical center; design; diagnostic accuracy; first-in-human; fluorescence imaging; human study; in vivo; in vivo Model; liver biopsy; liver cancer model; molecular imaging; novel; optical imaging; point of care; point of care testing; real-time images; regenerative

The system hardware and software were verified, integrated, and validated as one unit. The function and workflow in an in vivo model were defined and the clinical trial in human liver biopsy was begun. A custom electromagnetic (EM) tracking biopsy platform was modified to include visualization and quantification of ICG fluorescence intensity signals, derived from either an ICG fluorescence probe (for in vivo detection) or and ICG optical point-of-care (POC) system (for ex vivo specimen). Feasibility was evaluated in i) abdomen phantom with 0.001mg/ ICG injected ii) a woodchuck HCC model (in vivo and ex vivo biopsy cores, as well as explanted liver tissue) with intravenous injected ICG 1 day prior to biopsy. ICG fluorescence signal and diagnostic accuracy were defined. During EM-tracked ICG probe needle guidance in the phantom, the mean error between the first ICG fluorescence signal and the peak ICG fluorescence signal was about 5mm. In vivo, the EM-ICG biopsy platform was successful in targeting 7 biopsy locations and obtaining 10 biopsy cores. ICG-probe fluorescence intensity signal on ex vivo normal and cancerous liver specimens was able to be differentiated in a point of care testing system (camera and filters in a box). EM tracked coaxial needle combined with an ICG probe provided simultaneous and real-time navigation with optical molecular imaging feedback during hepatic tumor biopsy. Direct assessment of the biopsy cores using an ICG-POC system could provide real-time imaging feedback on type and quality of the derived biopsy core. EM tracking was predominantly useful for gross navigation towards a specified target (such as an arterial enhancing LIRADS 5 lesion), whereas the optical system was most useful for "fine-tuning" or smaller adjustments of sample locations. This method of use is set to be studied in the clinical trial which is IRB and FDA IDE ready as a minimal risk study. The regulatory pathway reflected the challenges of combining two novel systems in a drug and device, first in human study. Cytology point of care system results will be closely compared to in vivo signal results with ICG. Alternate designs that integrate FDA cleared EM tracking systems will be deployed.

系统硬件和软件已被验证，集成和验证为一个单元。定义了体内模型的功能和工作流程，并开始了人肝活检中的临床试验。 修改了自定义电磁（EM）跟踪活检平台，包括可视化和定量ICG荧光强度信号，该信号源自ICG荧光探针（用于体内检测）或ICG光学点（POC）系统（用于EX VIVO样品）。在i）注射0.001mg/ icg注射的腹部幻像中评估了可行性ii）woodchuck hcc模型（体内和外体活检核心以及植入的肝组织），并在活检前1天注射了静脉注射ICG。定义了ICG荧光信号和诊断精度。 在幻影中EM跟踪的ICG探针指导期间，第一个ICG荧光信号和峰ICG荧光信号之间的平均误差约为5mm。在体内，EM-ICG活检平台成功地瞄准了7个活检位置并获得10个活检核心。 离体正常和癌性肝样品上的ICG探针荧光强度信号能够在护理测试系统（盒子中的相机和过滤器）中分化。 EM跟踪的同轴针和ICG探针在肝肿瘤活检过程中与光学分子成像反馈一起提供了同时实时导航。使用ICG-POC系统对活检核心进行直接评估可以提供有关衍生活检核心类型和质量的实时成像反馈。 EM跟踪主要对于指向指定目标的总导航（例如动脉增强LIRADS 5病变）非常有用，而光学系统对于“微调”或较小的样本位置调整最有用。这种使用方法将在临床试验中进行研究，该试验是IRB和FDA IDE，作为一项最小风险研究。 监管途径反映了在人类研究中首先将两个新型系统组合在药物和装置中的挑战。与ICG的体内信号结果相比，细胞学的护理系统结果将得到密切的比较。将部署整合FDA清除EM跟踪系统的替代设计。