Trial Outcomes & Findings for Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps (NCT NCT05179837)
NCT ID: NCT05179837
Last Updated: 2025-03-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Within 5 minutes during standard of care colonoscopy - Day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes)
Results posted on
2025-03-19
Participant Flow
Participant milestones
| Measure |
Optical Coherence Tomography (OCT) Probe
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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|---|---|
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Overall Study
STARTED
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36
|
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Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Optical Coherence Tomography (OCT) Probe
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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|---|---|
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Overall Study
Lesion turned out to be scar tissue and not a polyp
|
1
|
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Overall Study
Device malfunctioned
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1
|
|
Overall Study
Image quality too low
|
2
|
Baseline Characteristics
Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps
Baseline characteristics by cohort
| Measure |
Optical Coherence Tomography (OCT) Probe
n=36 Participants
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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|---|---|
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Age, Continuous
|
64.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 5 minutes during standard of care colonoscopy - Day 1 (average length 3:40 minutes (full range 1:54-8:20 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.
Outcome measures
| Measure |
Optical Coherence Tomography (OCT) Probe
n=35 Participants
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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|---|---|
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Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes
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29 Participants
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SECONDARY outcome
Timeframe: From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days)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.
Outcome measures
| Measure |
Optical Coherence Tomography (OCT) Probe
n=35 Participants
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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|---|---|
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Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy
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0 Participants
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SECONDARY outcome
Timeframe: During colonoscopy (Day 1)Population: 4 participants were excluded due to absence of polyps (n=1), probe malfunction (n=1), and poor image quality (n=2).
Whether OCT image is successfully captured using machine learning algorithm, coded as "good" or "noisy".
Outcome measures
| Measure |
Optical Coherence Tomography (OCT) Probe
n=32 Participants
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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|---|---|
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Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm
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32 Participants
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SECONDARY outcome
Timeframe: During colonoscopy (Day 1)Population: 4 participants were excluded due to absence of polyps (n=1), probe malfunction (n=1), and poor image quality (n=2).
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.
Outcome measures
| Measure |
Optical Coherence Tomography (OCT) Probe
n=32 Participants
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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|---|---|
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Cohen's Weighted Kappa Score
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0.845 proportion of agreement
Interval 0.774 to 0.915
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Adverse Events
Optical Coherence Tomography (OCT) Probe
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Optical Coherence Tomography (OCT) Probe
n=35 participants at risk
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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|---|---|
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Cardiac disorders
Palpitations
|
2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
|
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Cardiac disorders
Potential statin myopathy
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2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
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Cardiac disorders
Tachycardia
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2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
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Gastrointestinal disorders
Abdominal pain
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2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
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Gastrointestinal disorders
Diarrhea
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2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
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Gastrointestinal disorders
Hematochezia
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5.7%
2/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
|
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Gastrointestinal disorders
Ileal hemorrhage
|
2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
|
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Gastrointestinal disorders
Vomiting
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2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
|
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General disorders
Fatigue
|
2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
|
|
General disorders
Fever
|
2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
|
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Infections and infestations
Urinary tract infection
|
2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
|
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Musculoskeletal and connective tissue disorders
Right arm pain
|
2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
|
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Vascular disorders
Hemorrhagic shock
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2.9%
1/35 • From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
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Other adverse events
Adverse event data not reported
Additional Information
Vladimir Kushnir, M.D.
Washington University School of Medicine
Phone: 314-362-3685
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place