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Completed

NCT Number: NCT04172493

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

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.

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Key information

Conditions

Patient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperspectral Endoscopy (HySE)

Procedure

Undergo hyperspectral endoscopy

Other names: Hyperspectral Endoscopic Imaging (HSI)

White Light Endoscopy (WLE)

Device

Undergo white light endoscopy

Other names: White Light Endoscopic Imaging

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • Oregon Health and Science University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2019
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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