PatientNCT04172493
Hyperspectral Endoscopy Imaging for the Early Detection of Precancerous Lesions in Average Risk Patients
A study testing Hyperspectral Endoscopy (HySE) and White Light Endoscopy (WLE) in people with Patient, run by OHSU Knight Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient
- What is being tested?
- Hyperspectral Endoscopy (HySE) and White Light Endoscopy (WLE)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to 27 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document
- Patients scheduled for a standard of care screening or surveillance colonoscopy
Who cannot join
- Any condition that, in the opinion of the investigator, precludes the patient from completion of the study procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess whether use of hyperspectral endoscopy (HySE) can improve visualization of abnormal colonic tissue.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Patient
- Being tested
- Hyperspectral Endoscopy (HySE), White Light Endoscopy (WLE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperspectral Endoscopy (HySE)Procedure or surgery
Also called Hyperspectral Endoscopic Imaging (HSI)
Undergo hyperspectral endoscopy
White Light Endoscopy (WLE)Device
Also called White Light Endoscopic Imaging
Undergo white light endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Experimental | Patients undergo standard of care white light endoscopy (WLE) and hyperspectral endoscopy (HySE) during routine colonoscopy procedure. Receives: Procedure: Hyperspectral Endoscopy (HySE); Device: White Light Endoscopy (WLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start26 Aug 2019
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PatientStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vassiliki Tsikitis, OHSU Knight Cancer Institute
- Investigators
- Vassiliki L Tsikitis, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172493
- Sponsor's protocol ID
- STUDY00018947
- Other IDs
- NCI-2019-06087, ONC-19132-L, STUDY00018947, P30CA069533
- Status last verified
- May 2020
- First submitted
- 5 Nov 2019
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperspectral Endoscopy Imaging for Early Detection of Precancerous Lesions in Average Risk Patients: Proof of Principle
- ClinicalTrials.gov ID
- NCT04172493
- Acronym / sponsor ID
- STUDY00018947
- Conditions
- Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To assess whether use of hyperspectral endoscopy (HySE) can improve visualization of abnormal colonic tissue.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Experimental | Procedure: Hyperspectral Endoscopy (HySE), Device: White Light Endoscopy (WLE)Patients undergo standard of care white light endoscopy (WLE) and hyperspectral endoscopy (HySE) during routine colonoscopy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Patients scheduled for a standard of care screening or surveillance colonoscopy
Key exclusion criteria (1 listed)
- Any condition that, in the opinion of the investigator, precludes the patient from completion of the study procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperspectral Endoscopy (HySE)Also: Hyperspectral Endoscopic Imaging (HSI)Undergo hyperspectral endoscopy | Procedure or surgery | Diagnostic |
| White Light Endoscopy (WLE)Also: White Light Endoscopic ImagingUndergo white light endoscopy | Device | Diagnostic |
Primary outcome
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.
1 secondary outcome
Imaging differences in polyp characteristics documented upon post-procedure video review
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vassiliki L Tsikitis principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperspectral Endoscopy (HySE) and White Light Endoscopy (WLE) in people with Patient, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectral profiles corresponding to normal versus abnormal colonic tissue (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.