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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
No Placebo-Only Group
Summary
This trial aims to test if a light-based imaging technique can better determine how deep colorectal cancer tumors have grown. It targets patients undergoing regular check-ups to improve treatment decisions. The technique works by creating detailed images of the colon's inner layers using reflected light.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes
Secondary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colon cancer include surgery, chemotherapy, radiation therapy, and targeted therapies. Surgery involves the physical removal of the tumor, which is crucial for localized cancer.
Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to destroy cancer cells. Targeted therapies, such as monoclonal antibodies, specifically attack cancer cell proteins or genes.
Understanding these mechanisms is vital for patients as it helps in selecting the most appropriate treatment based on the tumor's characteristics. High-resolution imaging modalities like Optical Coherence Tomography (OCT) are significant as they can accurately determine the depth of submucosal invasion, aiding in the decision between less invasive endoscopic procedures and more extensive surgical interventions.
Fibre optic confocal imaging (FOCI) for subsurface microscopy of the colon in vivo.Real-time colorectal cancer diagnosis using PR-OCT with deep learning.Multimodal endoscopy for colorectal cancer detection by optical coherence tomography and near-infrared fluorescence imaging.
Fibre optic confocal imaging (FOCI) for subsurface microscopy of the colon in vivo.Real-time colorectal cancer diagnosis using PR-OCT with deep learning.Multimodal endoscopy for colorectal cancer detection by optical coherence tomography and near-infrared fluorescence imaging.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,848 Total Patients Enrolled
Vladimir Kushnir, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
32 Total Patients Enrolled
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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.
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