Cancer of the Colon, Cancer of the Rectum, Colon Cancer, Malignant Polyp, Precancerous Polyp, Rectal Cancer
Conditions
Brief summary
Colorectal cancer arises from the mucosal layer of the colon. Current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. This method is somewhat limited in that there are no readily available surface pattern or morphological classification systems with adequate sensitivity or specificity to evaluate extent of submucosal invasion (deep, superficial, or none). Optical coherence tomography (OCT) using pattern recognition is a high-resolution imaging modality. There is currently an unmet need to predict depth of invasion for colonic tumors to decide on applicability of endoscopic (endoscopic submucosal dissection or endoscopic mucosal resection) vs. surgical therapy. The investigators' hypothesis is that OCT will have a higher diagnostic accuracy for determining depth of submucosal invasion compared to existing modalities. The investigators will first aim to assess the procedural feasibility and safety of using an OCT probe during routine colonoscopy with an early feasibility study. This study will identify appropriate modifications to the device and help with development of subsequent clinical study protocols. The eventual goal is to assess the diagnostic accuracy of OCT imaging for predicting depth of invasion of colonic tumors.
Interventions
The OCT probe is attached to an approximately 3-meter wire that is attached to the OCT fiber probe system setup. This setup consists of a power supply unit, and a control platform that controls fiber probe rotation and retraction. The OCT probe will be advanced through the colonoscope instrument channel
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing standard of care colonoscopy for the evaluation of colonic polyps. * 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).
Exclusion criteria
* Pregnant and/or breastfeeding. * Unable to tolerate sedation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohen's Weighted Kappa Score | During colonoscopy (Day 1) | 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. |
| Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy | 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. |
| Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm | During colonoscopy (Day 1) | Whether OCT image is successfully captured using machine learning algorithm, coded as good or noisy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device malfunctioned | 1 |
| Overall Study | Image quality too low | 2 |
| Overall Study | Lesion turned out to be scar tissue and not a polyp | 1 |
Baseline characteristics
| Characteristic | Optical Coherence Tomography (OCT) Probe |
|---|---|
| Age, Continuous | 64.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 6 / 35 |
Outcome results
Primary
Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 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.
Time frame: Within 5 minutes during standard of care colonoscopy - Day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optical Coherence Tomography (OCT) Probe | Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes | 29 Participants |
Secondary
Cohen's Weighted Kappa Score
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Optical Coherence Tomography (OCT) Probe | Cohen's Weighted Kappa Score | 0.845 proportion of agreement |
Secondary
Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm
Whether OCT image is successfully captured using machine learning algorithm, coded as good or noisy.
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optical Coherence Tomography (OCT) Probe | Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm | 32 Participants |
Secondary
Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy
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.
Time frame: From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optical Coherence Tomography (OCT) Probe | Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy | 0 Participants |