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Imaging
OCT Imaging for Colorectal Cancer
N/A
Waitlist Available
Led By Vladimir Kushnir, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 5 minutes during standard of care colonoscopy - day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes)
Awards & highlights
Study Summary
This trial is testing whether a new imaging method called OCT is better than current methods at predicting how deep a colonic tumor has invaded.
Who is the study for?
This trial is for individuals at least 40 years old who are undergoing a standard colonoscopy to check for colonic polyps. They must be able to understand and sign a consent form. Pregnant or breastfeeding individuals, or those unable to tolerate sedation, cannot participate.Check my eligibility
What is being tested?
The study is testing the use of an Optical Coherence Tomography (OCT) probe during routine colonoscopies. The goal is to see if OCT can more accurately determine the depth of invasion by colonic tumors than current methods, which could influence treatment decisions.See study design
What are the potential side effects?
Since this trial involves using an OCT probe during a standard colonoscopy procedure, side effects may include typical risks associated with endoscopic procedures such as discomfort, bleeding, or perforation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 5 minutes during standard of care colonoscopy - day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 5 minutes during standard of care colonoscopy - day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes
Secondary outcome measures
Cohen's Weighted Kappa Score
Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm
Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Optical coherence tomography (OCT) probeExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,673 Total Patients Enrolled
Vladimir Kushnir, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot handle being sedated.
Research Study Groups:
This trial has the following groups:- Group 1: Optical coherence tomography (OCT) probe
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research subjects are contributing to this investigation?
"Affirmative. It appears that this clinical trial is still recruiting, as evidenced by the details available on clinicaltrials.gov - first posted January 24th 2022 and updated November 8th 2022. 54 participants are needed for the study at 1 site."
Answered by AI
Are the researchers currently seeking participants for this investigation?
"Confirmed. According to clinicaltrials.gov, the trial was inaugurated on January 24th 2022 and is still actively searching for patients; the information has been recently updated on November 8th 2022."
Answered by AI
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