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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-06087 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ONC-19132-L | |||
| STUDY00018947 | Other Identifier | OHSU Knight Cancer Institute | |
| P30CA069533 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Oregon Health and Science University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic | Experimental | Patients undergo standard of care white light endoscopy (WLE) and hyperspectral endoscopy (HySE) during routine colonoscopy procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperspectral Endoscopy (HySE) | Procedure | Undergo hyperspectral endoscopy |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vassiliki L Tsikitis | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| White Light Endoscopy (WLE) | Device | Undergo white light endoscopy |
|
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| 1 year |