Screening of Barrett’s Esophagus (BE) for progression to esophageal adenocarcinoma with standard endoscopic biopsy is expensive, invasive, and imprecise due to sampling error and the limited value of histomorphology for predicting cancer risk. We have developed a technology called in vivo laser capture microdissection (IVLCM) that overcomes these issues by using OCT tethered capsule endomicroscopy (OCT-TCE) to image the entire esophagus at the microscopic level. Pilot clinical study results show that IVLCM samples provide sufficient DNA material for genetic sequencing. The comparison of sequencing quality and gene mapping of IVLCM samples and conventional FFPE biopsy samples will be analyzed in the ongoing clinical study.
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.
OCT-based tethered capsule endomicroscopy (TCE) is an emerging tool for unsedated Barrett’s Esophagus (BE) screening. Cancer progression risk is best determined by acquiring and analyzing a BE tissue sample. We report a TCE device with a biopsy channel capable of extracting tissue samples in an unsedated platform. We show in swine studies (n=2) the biopsy capsule can locate simulated targets and visualize the extraction of biopsies. Owing to its capacity to be utilized in patients without requiring sedation, this new technology could be useful for screening for BE subjects who have an elevated risk of developing cancer.
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.
High-resolution, extended depth-of-field (EDOF) optical coherence tomography (OCT) in tethered capsules can be achieved using a mirror-tunnel design, and then further modeled and optimized for enhanced performance. In this work, a model with initial dimensions yielded 13 µm full-width-at-half-maximum (FWHM) spot size over 1.5 mm DOF. An optimization algorithm produced a design that attained 8 µm FWHM over 1.5 mm DOF. The initial and optimized probes were fabricated, beam-profiled and integrated into capsules connected to a swept-source OCT system, for imaging swine esophagus in experiments. The resulting data comparison and analysis show the lateral resolution improvement achievable in optimized probes.
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.
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