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

NCT04172493 | Completed DMC FDA Device

• 4 other identifiers: STUDY00018947NCI-2019-06087ONC-19132-LP30CA069533
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Imaging differences in polyp characteristics documented upon post-procedure video review

  1 year

Study Arms (1)

Diagnostic

EXPERIMENTAL

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

Procedure: Hyperspectral Endoscopy (HySE); Device: White Light Endoscopy (WLE)

Interventions

Hyperspectral Endoscopy (HySE) PROCEDURE

Undergo hyperspectral endoscopy

Also known as: Hyperspectral Endoscopic Imaging (HSI)

Diagnostic

White Light Endoscopy (WLE) DEVICE

Undergo white light endoscopy

Also known as: White Light Endoscopic Imaging

Diagnostic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document
• Patients scheduled for a standard of care screening or surveillance colonoscopy

You may not qualify if:

• Any condition that, in the opinion of the investigator, precludes the patient from completion of the study procedure

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Study Officials

• Vassiliki L Tsikitis

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 21, 2019
• Study Start: August 26, 2019
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

US (1)