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

Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172493
• Other study ID #: STUDY00018947
• Secondary ID: NCI-2019-06087ON
• Status: Completed
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: January 27, 2020

Study information

• Verified date: May 2020
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 27, 2020
• Est. primary completion date: January 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient

Intervention

Procedure:
• Hyperspectral Endoscopy (HySE)
Undergo hyperspectral endoscopy

Device:
• White Light Endoscopy (WLE)
Undergo white light endoscopy

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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.	1 year