Optical and electromagnetic tracking guidance for hepatic interventions

系统硬件和软件作为一个单元进行验证、集成和确认。定义了体内模型的功能和工作流程，并开始了人体肝活检的临床试验。 对定制电磁（EM）跟踪活检平台进行了修改，以包括ICG荧光强度信号的可视化和定量，这些信号来源于ICG荧光探针（用于体内检测）或ICG光学护理点（POC）系统（用于体外标本）。在i）注射0.001 mg/ ICG的腹部体模和ii）活检前1天静脉注射ICG的土拨鼠HCC模型（体内和离体活检芯以及活检肝组织）中评价了可行性。定义ICG荧光信号和诊断准确性。 在体模中的EM跟踪ICG探针引导期间，第一ICG荧光信号与峰值ICG荧光信号之间的平均误差约为5 mm。在体内，EM-ICG活检平台成功靶向7个活检位置并获得10个活检芯。 离体正常和癌性肝脏样本上的ICG探针荧光强度信号能够在护理点测试系统（盒子中的相机和滤光器）中区分。 在肝肿瘤活检过程中，EM跟踪同轴针与ICG探头结合使用，通过光学分子成像反馈提供同步和实时导航。使用ICG-POC系统对活检芯的直接评估可以提供关于所导出的活检芯的类型和质量的实时成像反馈。 EM跟踪主要用于朝向指定目标（例如动脉增强LIRADS 5病变）的大体导航，而光学系统最适用于“微调”或样本位置的较小调整。该使用方法将在IRB和FDA IDE准备就绪的临床试验中进行研究，作为最小风险研究。 调控途径反映了在药物和设备中结合两种新系统的挑战，首先是在人体研究中。将细胞学床旁系统结果与ICG的体内信号结果进行密切比较。将部署集成FDA批准的EM跟踪系统的替代设计。

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.