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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05179837
• Other study ID #: 202103151
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

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:

• Pregnant and/or breastfeeding.

• Unable to tolerate sedation.

Related Conditions & MeSH terms

• Cancer of the Colon
• Cancer of the Rectum
• Colon Cancer
• Colonic Neoplasms
• Polyps
• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• Optical coherence tomography probe
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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 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.	Within 5 minutes during standard of care colonoscopy - Day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes)
Secondary	Number of Participants With 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)
Secondary	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)
Secondary	Cohen's Weighted Kappa Score	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.	During colonoscopy (Day 1)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine