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

May 6, 2020 updated by: Vassiliki Tsikitis, OHSU Knight Cancer Institute

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Knight Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Hyperspectral Endoscopic Imaging (HSI)
Undergo white light endoscopy
Other Names:
  • White Light Endoscopic Imaging

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vassiliki L Tsikitis, OHSU Knight Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Actual)

January 27, 2020

Study Completion (Actual)

January 27, 2020

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

May 1, 2020

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

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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