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Cola

After consent, the endoscopist will perform a standard of care colonoscopy. If a polyp is found, then OCT will be used to image that polyp. Patients with polyps, regardless of number found, will have either one tubular adenoma (NICE type 2) imaged OR one hyperplastic polyp (NICE type 1) imaged. If no polyps are found, then one area of normal mucosa will be imaged. If on the rare chance a malignant appearing colonic tumor (NICE type 3) is found, this and no other polyps will be imaged with OCT.

The OCT probe is attached to an approximately 3-meter wire that is attached to the OCT fiber probe system setup. This setup consists of a power supply unit, and a control platform that controls fiber probe rotation and retraction. The OCT probe will be advanced through the colonoscope instrument channel

Optical coherence tomography probe

Vladimir Kushnir, M.D.

Colorectal cancer arises from the mucosal layer of the colon. Current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. This method is somewhat limited in that there are no readily available surface pattern or morphological classification systems with adequate sensitivity or specificity to evaluate extent of submucosal invasion (deep, superficial, or none). Optical coherence tomography (OCT) using pattern recognition is a high-resolution imaging modality. There is currently an unmet need to predict depth of invasion for colonic tumors to decide on applicability of endoscopic (endoscopic submucosal dissection or endoscopic mucosal resection) vs. surgical therapy. The investigators' hypothesis is that OCT will have a higher diagnostic accuracy for determining depth of submucosal invasion compared to existing modalities. The investigators will first aim to assess the procedural feasibility and safety of using an OCT probe during routine colonoscopy with an early feasibility study. This study will identify appropriate modifications to the device and help with development of subsequent clinical study protocols. The eventual goal is to assess the diagnostic accuracy of OCT imaging for predicting depth of invasion of colonic tumors.

Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps

Early Feasibility Study of Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps

If the proportion of the patients whose procedure length using an OCT probe during routine colonoscopy is within 5 minutes is greater than 75%, then the feasibility is defined in this study.

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

Whether OCT image is successfully captured using machine learning algorithm, coded as "good" or "noisy".

Overall agreement (OCT probe yielding results consistent with clinical pathology biopsy results) as measured by Cohen's Kappa. Overall Cohen's Kappa is a statistical measure for assessing the reliability of agreement between the two results by taking into account the element of chance. Cohen's kappa can range from 0 to 1 with 1 indicating perfect agreement and 0 indicating an agreement equivalent to chance.

Clinical pathology is the gold standard for diagnosis. Diagnosis from both OCT and clinical pathology will be assigned as normal mucosa, hyperplastic polyp, tubular adenoma, sessile serrated adenoma, or colorectal cancer.

Washington University School of Medicine

Optical Coherence Tomography (OCT) Probe

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes

Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy

4 participants were excluded due to absence of polyps (n=1), probe malfunction (n=1), and poor image quality (n=2).

Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm

Cohen's Weighted Kappa Score

Overall Study

The examination of gastrointestinal tract resected specimen with the use of the OCT probe

Use of OCT probe for examination of gastrointestinal tract

Optical Coherence Tomography Probe

Hon Chi Yip, MBChB

This is a pilot study aiming to investigate the ability of a novel Optical Coherence Tomography (OCT) probe in assessing the different layers of the gastrointestinal tract and the depth of invasion of early neoplasia, utilising surgically and endoscopically resected specimens

Endoscopic treatment of early neoplasia in the gastrointestinal tract has been established as the standard therapy in the past decade. Various endoscopic resection techniques have been developed, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), to ensure complete removal of such lesions and avoid recurrence. Successful endoscopic resection of early gastrointestinal (GI) neoplasia relies on accurate pre-procedural prediction of the margin and depth of invasion of the corresponding lesions. Generally, GI neoplasia (even carcinoma) confined to the mucosa layer could be safely removed endoscopically with margin negative resection and minimal chance of lymph node involvement.

Image-enhanced endoscopy or endoscopic ultrasonography has been used as the modality of pre-resection assessment on the depth of invasion. Chromoendoscopy and digital enhancement such as magnifying Narrow Band Imaging (NBI) focus on characterization of the surface morphology and the vascular structures and predict the depth of invasion instead of direct depth measurement. Endoscopic ultrasonography allows good visualization of the different layers of GI tract, but the ability to differentiate early mucosal (T1a) or submucosal invasive (T1b) cancer remains limited owing to its low resolution (\>100um). A small proportion of patients subjected for endoscopic resection had invasive cancer not curable by endoscopic means and require additional surgery afterwards. There is thus a potential role for further refinement of imaging technique to allow better prediction of tumor depth in early GI neoplasia.

Optical coherence tomography (OCT) is a novel high spatial-resolution, cross-sectional imaging technique that allows visualization of biological tissue at higher resolution (\~10um). It has been used routinely in the field of ophthalmology for retinal assessment. Earlier studies have also confirmed the potential application in the gastrointestinal tract with a probe-based design to be placed within an endoscopy.

The Department of Mechanical and Automation Engineering from the Chinese University of Hong Kong have recently designed a novel OCT probe that could be placed within the working channel of an endoscope. In-vitro experiment with porcine intestinal model demonstrated its ability to provide high-resolution images with visualization of different layers of the GI tract. The investigators therefore design this pilot study to assess the application of the OCT probe in human resected tissue specimen to assess the ability in determining different layers of GI tract and depth of invasion of GI tumors.

The current pilot study is designed aiming to assess the ability of the novel OCT probe in visualization of the layers of the human GI tract and depth of invasion of GI neoplasia in resected surgical and endoscopic specimens. There would be two parts of the study:

1. To visualize normal gastrointestinal tract in a resected surgical specimen of esophageal, stomach, small bowel and colonic tissue.
2. To assess the depth of invasion of the neoplastic tissue in surgical specimens as well as endoscopic (ESD) specimens

The Use of a OCT Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal Tract

The Use of a Novel Optical Coherence Tomography (OCT) Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal Tract

Visualisation of different layers of gastrointestinal tract. Ability to differentiate mucosa and submucosa and muscular propria layer. (Yes or No).

Ability to assess depth of invasion of resected GI early tumor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps	NCT05179837	Colon Cancer Rectal Cancer Cancer of the R... Cancer of the C... Precancerous Po... Malignant Polyp	Optical coheren...	40 Years -	Washington University School of Medicine
The Use of a OCT Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal Tract	NCT04670718	Gastrointestina...	Optical Coheren...	18 Years -	Chinese University of Hong Kong

Spots Global Cancer Trial Database for optical coherence tomography probe