OCT Imaging for Colorectal Cancer

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

Trial Summary

What is the purpose of this trial?

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.

Research Team

Vladimir Kushnir, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+