Hyperspectral Endoscopy Imaging for the Early Detection of Precancerous Lesions in Average Risk Patients

Study Overview
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Brief Summary
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This trial studies whether hyperspectral endoscopy improves visualization of abnormal tissue in average risk patients during standard-of-care colonoscopies. Hyperspectral endoscopy is an emerging technique that has the potential to enable the signals from blood to be resolved from tissue-specific signals. Image-enhanced endoscopy may improve visualization of abnormal colonic tissue when compared to the standard-of-care high-definition white light endoscopy.

Detailed Description
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PRIMARY OBJECTIVE: I. To assess whether use of hyperspectral endoscopy (HySE) can improve visualization of abnormal colonic tissue. SECONDARY OBJECTIVES: I. To assess whether use of HySE could reduce the rate of missed flat polyps. II. To assess whether use of HySE might in the future reduce the incomplete resection rate (IRR). III. To examine accuracy of practitioners in predicting polyp histology. OUTLINE: Patients undergo standard of care white light endoscopy and hyperspectral endoscopy during routine colonoscopy procedure. After completion of study, patients who experience a colonoscopy-related severe adverse event are followed up until resolution or stabilization of the event.

Official Title
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Hyperspectral Endoscopy Imaging for Early Detection of Precancerous Lesions in Average Risk Patients: Proof of Principle

Conditions
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Patient

Intervention / Treatment
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* Procedure: Hyperspectral Endoscopy (HySE)
* Device: White Light Endoscopy (WLE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document Patients scheduled for a standard of care screening or surveillance colonoscopy Exclusion Criteria: Any condition that, in the opinion of the investigator, precludes the patient from completion of the study procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic<br>Patients undergo standard of care white light endoscopy (WLE) and hyperspectral endoscopy (HySE) during routine colonoscopy procedure. | Procedure: Hyperspectral Endoscopy (HySE)<br>* Undergo hyperspectral endoscopy<br>* Other names: Hyperspectral Endoscopic Imaging (HSI);Device: White Light Endoscopy (WLE)<br>* Undergo white light endoscopy<br>* Other names: White Light Endoscopic Imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectral profiles corresponding to normal versus abnormal colonic tissue | Will apply a multivariate statistical analysis such as spectral angle mapper to determine whether the spectra are significantly different as determined by light spectral bandwidth measurements. | 1 year | 
| Image quality | Assessed by the endoscopist, based on level of confidence in delineating the area of interest. Will assess and compare the number of polyps found by standard light endoscopy and narrow band imaging with hyperspectral endoscopy. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging differences in polyp characteristics documented upon post-procedure video review | Will be compared with the final read of the pathology of the polyps. A Pearson X2 test or equivalent test will be applied. When applicable, Fisher exact test and Pearson X2 test will be used to test for differences in categorical variables, which include analysis of polyp morphologic structure and location. A student t test or equivalent statistical test will be used to test for differences in continuous variables, including polyp diameter. | 1 year |