Clinical trial NCT05179837: Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps
Official title: Early Feasibility Study of Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Cancer of the Rectum
Cancer of the Colon
Precancerous Polyp
Malignant Polyp
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes
timeFrame: Within 5 minutes during standard of care colonoscopy - Day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes)
Secondary outcomes:
measure: Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy
timeFrame: From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days)
measure: Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm
timeFrame: During colonoscopy (Day 1)
measure: Cohen's Weighted Kappa Score
timeFrame: During colonoscopy (Day 1)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Vladimir Kushnir, M.D.
role: PRINCIPAL_INVESTIGATOR
References: