Custom bile duct phantom for first-in-human multiplexed NIR fluorescence peptide imaging

Yang, Jing; Cooper, David J; Carson, Matthew D.; Seibel, Eric J.

doi:10.1117/12.2509893

Cited by 3 publications

(5 citation statements)

References 12 publications

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“…This functional biopsy device assembly will be tested in a phantom of the biliary system, which will be made of a silicone rubber that possesses tissue-like mechanical and optical properties. The synthetic tissue will be dyed so that the location of the cut fragments can be tracked [26] . Here, the capture system for the tissue fragments can additionally be tested, which will be facilitated either using additional fluid suction through the pusher tube by a syringe or through the addition of a thin sheath over the biopsy device.…”

Section: Discussionmentioning

confidence: 99%

Intraductal Tissue Sampling Device Designed for the Biliary Tract

Patel

Carson

Seibel

et al. 2021

IEEE J. Transl. Eng. Health Med.

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Clinical sampling of tissue that is read by a pathologist is currently the gold standard for making a disease diagnosis, but the few minimally invasive techniques available for small duct biopsies have low sensitivity, increasing the likelihood of false negative diagnoses. We propose a novel biopsy device designed to accurately sample tissue in a biliary stricture under fluoroscopy or endoscopic guidance. The device consists of thin blades organized around the circumference of a cylinder that are deployed into a cutting annulus capable of comprehensively sampling tissue from a stricture. A parametric study of the device performance was done using finite element analysis; this includes the blade deployment under combined axial compression and torsion followed by an axial ‘cutting’ step. The clinical feasibility of the device is determined by considering maximum deployment forces, the radial expansion achieved and the cutting stiffness. We find practical parameters for the device operation to be an overall length of 10 mm and a diameter of 3.5 mm for a \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$50~\mu \text{m}$ \end{document} blade thickness, which allow the device to be safely deployed with a force of 10N and achieve an expansion over 3x its original diameter. A model device was fabricated with these parameters and a \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$75~\mu \text{m}$ \end{document} thickness out of a NiTi superalloy and tested to validate the performance. The device showed strong agreement with an equivalent numerical model, reaching a peak force within 2% of that predicted numerically and fully recovering after compression to 20% of its length. Clinical and Translational Impact Statement –This pre-clinical research conceptually demonstrates a novel expandable device to biopsy tissue in narrow strictures during an ERCP procedure. It can greatly improve diagnostic tissue yield compared to existing methods.

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Section: Discussionmentioning

confidence: 99%

Intraductal Tissue Sampling Device Designed for the Biliary Tract

Patel

Carson

Seibel

et al. 2021

IEEE J. Transl. Eng. Health Med.

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“…Furthermore, Jiang et al. 38 created a bile duct phantom with NIR fluorescent targets for practicing a clinical study protocol ( Fig. 6 ).…”

Section: Methodsmentioning

confidence: 99%

“… The 3D optical tissue phantom created by Jian et al 38 to mimic the gall bladder. (a) Designs and (b) images of the inside, created with fluorescence endoscopy.…”

Section: Methodsmentioning

confidence: 99%

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Standardization and implementation of fluorescence molecular endoscopy in the clinic

et al. 2022

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. Significance: Near-infrared fluorescence molecular endoscopy (NIR-FME) is an innovative technique allowing for in vivo visualization of molecular processes in hollow organs. Despite its potential for clinical translation, NIR-FME still faces challenges, for example, the lack of consensus in performing quality control and standardization of procedures and systems. This may hamper the clinical approval of the technology by authorities and its acceptance by endoscopists. Until now, several clinical trials using NIR-FME have been performed. However, most of these trials had different study designs, making comparison difficult. Aim: We describe the need for standardization in NIR-FME, provide a pathway for setting up a standardized clinical study, and describe future perspectives for NIR-FME. Body: Standardization is challenging due to many parameters. Invariable parameters refer to the hardware specifications. Variable parameters refer to movement or tissue optical properties. Phantoms can be of aid when defining the influence of these variables or when standardizing a procedure. Conclusion: There is a need for standardization in NIR-FME and hurdles still need to be overcome before a widespread clinical implementation of NIR-FME can be realized. When these hurdles are overcome, clinical outcomes can be compared and systems can be benchmarked, enabling clinical implementation.

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“…Nonetheless, most of these phantoms are tailored towards standardization of FMI systems and are not fully compatible with the requirements of FME [8]. On the other hand, most FME phantoms proposed to date have been designed for training purposes, limiting their application as fluorescence standards [20,21]. For example, the anthropomorphic elastomer phantom proposed by Yang et al mimics healthy and Barrett's esophagus mucosal layers as a training aid for using an FME system rather than for the assessment of a system's performance [20].…”

mentioning

confidence: 99%

Performance Assessment and Quality Control of Fluorescence Molecular Endoscopy With a Multi-Parametric Rigid Standard

Tenditnaya,

Gabriëls,

Hooghiemstra

et al. 2024

IEEE Trans. Med. Imaging

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Fluorescence molecular endoscopy (FME) is emerging as a "red-flag" technique with potential to deliver earlier, faster, and more personalized detection of disease in the gastrointestinal tract, including cancer, and to gain insights into novel drug distribution, dose finding, and response prediction. However, to date, the performance of FME systems is assessed mainly by endoscopists during a procedure, leading to arbitrary, potentially biased, and heavily subjective assessment. This approach significantly affects the repeatability of the procedures and the interpretation or comparison of the acquired data, representing a major bottleneck towards the clinical translation of the technology. Herein, we propose a robust methodology for FME performance assessment and quality control that is based on a novel multi-parametric rigid standard. This standard enables the characterization of an FME system's sensitivity through a single acquisition, performance comparison of multiple systems, and, for the first time, quality control of a system as a function of time and number of usages. We show the photostability of the standard experimentally and demonstrate how it can be used to characterize the performance of an FME system. Moreover, we showcase how the standard can be employed for quality control of a system. In this study, we find that the use of composite fluorescence standards before endoscopic procedures can ensure that an FME system meets the performance criteria and that components prone to performance degradation are replaced in time, avoiding disruption of clinical endoscopy logistics. This will help overcome a major barrier for the translation of FME into the clinics.

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Custom bile duct phantom for first-in-human multiplexed NIR fluorescence peptide imaging

Cited by 3 publications

References 12 publications

Intraductal Tissue Sampling Device Designed for the Biliary Tract

Intraductal Tissue Sampling Device Designed for the Biliary Tract

Standardization and implementation of fluorescence molecular endoscopy in the clinic

Performance Assessment and Quality Control of Fluorescence Molecular Endoscopy With a Multi-Parametric Rigid Standard

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