- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04172493
Hyperspectral Endoscopy Imaging for the Early Detection of Precancerous Lesions in Average Risk Patients
Hyperspectral Endoscopy Imaging for Early Detection of Precancerous Lesions in Average Risk Patients: Proof of Principle
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic
Patients undergo standard of care white light endoscopy (WLE) and hyperspectral endoscopy (HySE) during routine colonoscopy procedure.
|
Undergo hyperspectral endoscopy
Other Names:
Undergo white light endoscopy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spectral profiles corresponding to normal versus abnormal colonic tissue
Time Frame: 1 year
|
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
Time Frame: 1 year
|
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
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vassiliki L Tsikitis, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00018947 (Other Identifier: OHSU Knight Cancer Institute)
- P30CA069533 (U.S. NIH Grant/Contract)
- NCI-2019-06087 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- ONC-19132-L
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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