OCT Imaging for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Vladimir Kushnir, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Pregnant, Breastfeeding, Sedation intolerance

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using an optical coherence tomography (OCT) probe during colonoscopies. The researchers aim to determine if OCT can more accurately predict the depth of tumor growth into the colon lining, aiding doctors in selecting the best treatment method. Individuals undergoing colonoscopies to check for colon polyps (small growths in the colon) might be suitable for this trial. Participants can expect the OCT probe to image any polyps or normal areas found during their procedure. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance future colonoscopy procedures.

What prior data suggests that this OCT probe is safe for colorectal cancer screening?

Research has shown that using an optical coherence tomography (OCT) probe during a colonoscopy is safe and practical. In past studies, OCT examined polyps during regular colonoscopies without causing major issues. Most patients tolerate the procedure well, and it only adds a few extra minutes to the overall time.

The OCT probe enhances the view of the colon's surface, aiding in the detection of problem areas. This imaging method is well-tolerated, and no serious side effects have been reported. Overall, OCT is considered a safe tool to improve colonoscopy exams. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about optical coherence tomography (OCT) for colorectal cancer because it offers a unique, non-invasive imaging technique that can provide real-time, high-resolution images of polyps during a colonoscopy. Unlike standard procedures that rely on visual inspection and biopsy, OCT can differentiate between types of polyps and potentially identify malignant features without needing tissue removal. This ability to image tissue at a microscopic level could lead to quicker and more accurate diagnoses, reducing the need for unnecessary biopsies and helping doctors make immediate decisions during the procedure.

What evidence suggests that the OCT probe is effective for colorectal cancer imaging?

Research has shown that Optical Coherence Tomography (OCT), the investigational tool used in this trial, holds promise for diagnosing colorectal cancer. Studies indicate that OCT can accurately distinguish between normal and abnormal tissue, functioning like an "optical biopsy" in both animals and humans. One study found that OCT images of colon tissue were about 98% accurate in identifying abnormal polyps compared to normal ones. This capability may help determine tumor depth, crucial for selecting the appropriate treatment. Overall, OCT has great potential to enhance how doctors assess and treat colon polyps and cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Vladimir Kushnir, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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).

Undergoing standard of care colonoscopy for the evaluation of colonic polyps.

Exclusion Criteria

Pregnant and/or breastfeeding.

You cannot handle being sedated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a standard of care colonoscopy with OCT imaging to assess procedural feasibility and safety

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events related to OCT imaging

3 days

What Are the Treatments Tested in This Trial?

Interventions

• Optical coherence tomography probe

Trial Overview 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.

How Is the Trial Designed?

Group I: Optical coherence tomography (OCT) probe Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05179837

Endoscopic Optical Coherence Tomography for Screening ... The eventual goal is to assess the diagnostic accuracy of OCT imaging for predicting depth of invasion of colonic tumors. Official Title. Early Feasibility ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7052898/

Real-time colorectal cancer diagnosis using PR-OCT with ... OCT has been shown to accurately differentiate abnormal from normal tissue in multiple organs as an “optical biopsy” tool- in both murine and human colorectal ...

3. biomedical-engineering-online.biomedcentral.com biomedical-engineering-online.biomedcentral.com/articles/10.1186/s12938-025-01443-z

Classification of colon polyps with malignant potential using ... The aim of this study was to use Optical Coherence Tomography (OCT) for the classification of pre-malignant polyps as benign (i.e., normal or ...

4. nature.com nature.com/articles/s41598-024-55338-5

High-resolution rectoscopy using MHz optical coherence ... This real-time-3D-OCT holds promise as a valuable future diagnostic tool for assessing disease state and therapy response on-site in rectal diseases.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265449/

Deep learning for the detection of colon polyps ... A recent study, by Kendall et al, compared OCT images of normal colon epithelium with adenomatous polyps and resulted in ∼98% accuracy [26].

6. reporter.nih.gov reporter.nih.gov/project-details/11142667

Project Details - NIH RePORTER Here, we will create and clinically validate a new OCT system and two distinct OCT probes that are optimized for adenoma screening. The OCT system will utilize ...

7. nature.com nature.com/articles/s41598-024-78891-5

In vivo evaluation of complex polyps with endoscopic ... OCT is feasible and safe for polyp assessment during routine colonoscopy. When combined with deep learning, OCT offers clinicians increase ...

8. engineering.washu.edu engineering.washu.edu/news/2024/Colon-polyps-diagnosed-more-accurately-by-adding-OCT-to-colonoscopy.html

Colon polyps diagnosed more accurately by adding OCT to ... Adding the endoscopic OCT imaging increased the time of the colonoscopy by an average of 3 minutes and 40 seconds, though nearly 83% of patients ...

9. link.springer.com link.springer.com/article/10.1007/s00464-024-11353-1

Evaluation of a novel forward-looking optical coherence ... The aim of this study is to prospectively assess the feasibility of this advanced OCT probe in interpreting ex vivo images of colorectal polyp tissue.