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

Not Applicable

Terminated

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

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Optical coherence tomography (OCT) probe	Optical coherence tomography probe	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes	Within 5 minutes during standard of care colonoscopy - Day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy	From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days)	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.
Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm	During colonoscopy (Day 1)	Whether OCT image is successfully captured using machine learning algorithm, coded as "good" or "noisy".
Cohen's Weighted Kappa Score	During colonoscopy (Day 1)	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.