In our first clinical experience, we have found that Retrograde Tethered Capsule Endomicroscopy (R-TCE) was able to be advanced ~ 30 cm in 3 minutes in the colon of an unsedated study subject. R-TCE imaging enabled full circumferential OCT visualization of 96.60 ± 0.22 (95% CI) of the human colon wall. 3D rendered flythroughs of R-TCE OCT images demonstrate comprehensive visualization behind colonic folds where pre-neoplastic lesions may be missed by colonoscopy. The R-TCE procedure was well-tolerated, there were no complications, and a sigmoidoscopy conducted after the procedure did not show any R-TCE-related mucosal damage.
Our lab has developed a 2-mm-diameter transnasal introduction tube (TNIT) that enables safe and rapid optical coherence tomography (OCT) imaging of the upper gastrointestinal tract in unsedated pregnant women. Here, we report our clinical experience with TNIT-based OCT imaging in unsedated pregnant women (n=5) at Mass General Hospital (MGH). Results show that OCT imaging of the esophagus, stomach, and duodenum can be safely and effectively conducted in pregnant women with this device.
To address the need for less invasive and more accurate upper gastrointestinal biopsy, we have developed a swallowable optical-coherence tomography (OCT) tethered capsule endomicroscopy (TCE) device with image-targeted biopsy capabilities. The laser-captured biopsy can be used for histopathology and genetic analysis that could potentially improve the accuracy and reduce the cost of GI disease surveillance. Ex-vivo and in-vivo experiments on swine were conducted to optimize laser parameters, coating thickness, DNA isolation protocol, and histology of IVLCM samples. Results show that >200 ng of dsDNA can be isolated from the captured sample, which is sufficient for genetic analysis.
We report the use of our multimodal near-infrared fluorescence (NIRF) and OCT imaging system and catheter to perform the first imaging of LUM015 inflammatory activity in rabbit models of atherosclerosis in vivo. Using co-injection and multi-channel intravascular NIRF-OCT, we compared LUM015 (6.2 mg/kg) and preclinical ProSense (VM110, 3.5 mg/kg) fluorescence in the same subject. We found that co-registered fluorescence carpet maps were remarkably similar with a PCC of 0.51 and a Mander’s overlap coefficient of 0.79. Results suggest that LUM015 will be a viable clinical option for intracoronary imaging of plaque inflammatory activity in patients.
Tethered capsule endomicroscopy (TCE) is a recently developed form of in vivo microscopy based on optical coherence tomography (OCT). With TCE, a small tethered pill is swallowed, procuring high resolution microscopic images of the esophageal wall. TCE does not require sedation and is thus a more rapid and convenient procedure comparing to traditional endoscopic examination. Our group and others have successfully conducted OCT-TCE in pilot, single-center studies that demonstrated the potential of this technology for upper GI tract diagnosis. Here, we demonstrate and evaluate the feasibility and safety of a next generation OCT-TCE system and device in patients with Barrett’s esophagus (BE) and report the initial longitudinal analysis of the natural history of BE.
The Tearney Lab at the Massachusetts General Hospital (MGH) has conducted a study using Tethered Capsule Endomicroscopy (TCE), a technique that involves swallowing a tethered capsule device that circumferentially scans an optical coherence technology (OCT) beam inside the body as it traverses the gastrointestinal tract. Throughout the procedure, microscopic images of the esophagus are acquired in real time in an unsedated subject. OCT TCE was used to screen for Barrett’s Esophagus in a setting of 2 primary care practices at MGH.The OCT TCE show promising results identifying BE in a primary care population.
KEYWORDS: Optical coherence tomography, Luminescence, Imaging systems, Tissues, Process control, Near infrared, Visualization, Standards development, Lens design, Control systems
We present our next generation clinical dual-modality OCT and near infrared autofluorescence/fluorescence (NIRAF/NIRF) imaging platform. This platform allows combined tissue microstructure visualization (OCT) and obtaining molecular information either by intrinsic tissue near infrared autofluorescence (NIRAF) or by exogenous near infrared fluorescence contrast agents (NIRF). Components of this platform, OCT-NIRAF/NIRF imaging system, rotary junction and catheters, were developed using an industry standard design control processes to enable quality clinical translation. We have identified sources of image degradation in dual-modality catheter-based imaging (e.g. core-cladding crosstalk in OCT, background noise in fluorescence) and present methods to mitigate their effects. We also show catheter fabrication and validation, as well as automated fluorescence sensitivity and distance calibration methods that ensure robust and repeatable system performance.
We introduce two multimodal extensions of our optical coherence tomography (OCT) based tethered capsule endomicroscopy (TCE) platform, tailored towards an enhanced clinical applicability for upper gastrointestinal tract imaging. The first extension presented – white light (RGB)-OCT-based TCE – provides both, true-color visualization of the tissue surface and depth-resolved sub-surface OCT imaging, co-registered in time and space. The second extension presented – fluorescence (FL)-OCT-based TCE – enables the addition of tissue specific molecular contrast. We present compact, modular, easily portable, plug-and-play system designs for both extensions, as well as imaging results in swine esophagus, in vivo.
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