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

Overview

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.

Full Title of Study: “Hyperspectral Endoscopy Imaging for Early Detection of Precancerous Lesions in Average Risk Patients: Proof of Principle”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 27, 2020

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.

Interventions

  • Procedure: Hyperspectral Endoscopy (HySE)
    • Undergo hyperspectral endoscopy
  • Device: White Light Endoscopy (WLE)
    • Undergo white light endoscopy

Arms, Groups and Cohorts

  • Experimental: Diagnostic
    • Patients undergo standard of care white light endoscopy (WLE) and hyperspectral endoscopy (HySE) during routine colonoscopy procedure.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • OHSU Knight Cancer Institute
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vassiliki Tsikitis, Principal Investigator – OHSU Knight Cancer Institute
  • Overall Official(s)
    • Vassiliki L Tsikitis, Principal Investigator, OHSU Knight Cancer Institute

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