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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colon Cancer, Rectal Cancer, Cancer of the Rectum, Cancer of the Colon, Precancerous Polyp, Malignant Polyp

Intervention / Treatment
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* Device: Optical coherence tomography probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing standard of care colonoscopy for the evaluation of colonic polyps. At least 40 years of age. Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: Pregnant and/or breastfeeding. Unable to tolerate sedation.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optical coherence tomography (OCT) probe<br>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. | Device: Optical coherence tomography probe<br>* 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<br>* Other names: OCT probe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants that have a lesion that can be adequately evaluated with OCT | 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. | Within 5 minutes during standard of care colonoscopy (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events related to OCT imaging during routine colonoscopy | 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. | From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days) | 
| Number of participants who have a successfully captured OCT image using machine learning algorithm | Whether OCT image is successfully captured using machine learning algorithm, coded as good or noisy. | During colonoscopy (Day 1) | 
| Weighted kappa | 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. | During colonoscopy (Day 1) |