Colorectal CancerNCT02016326
I-Scan Vs High Definition White Light (Main Study)
A study testing HD Colon, I-scan 1 and I-Scan 2 in people with Colorectal Cancer, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC. Primary Outcome: Adenoma Detection Rate (ADR - No. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- HD Colon, I-scan 1 and I-Scan 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Nov 2014
- 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 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All increased risk patients (Patients with family history or personal history of colon polyps or colon cancer and FOBT positive) referred for a screening colonoscopy at the Forzani and MacPhail Colon Cancer Screening Centre will be considered for enrollment.
Who cannot join
- Average Risk patients
- Previous colon surgery
- Hereditary Polyposis Syndromes
- Suspected polyps or CRC before colonoscopy that have been suggested by another modality (Barium Enema, Virtual Colonoscopy, Flexible Sigmoidoscopy)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services
Calgary, Alberta, T2N 4N1
Dr. Steven Heitman, MD, (403)592-5020, steven.heitman@albertahealthservices.ca
Anitha Jambula, M.Sc, CCRP, (403)592-5019, ajambula@ucalgary.ca
About this study
Official title: A Randomized Controlled Trial Comparing High-definition White Light Colonoscopy to I-scan Enhanced Colonoscopy for Adenoma Detection in a Population at Increased Risk of Colorectal Cancer (Main Study)
The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.
Primary Outcome:
Read more
Adenoma Detection Rate (ADR - No. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.
Secondary Outcomes:
- Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.
- Adenoma Detection Rate (ADR) in the right colon during the "Second look", irrespective of imaging modality.
- Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were found(regardless of the histological type) divided by the total no. of colonoscopies performed in the Same time period) for each arm of the study in Right colon and throughout the entire colon.
- Mean number of adenomas per procedure for each arm of the study in right colon and throughout the entire colon.
- Mean number of polyps per procedure for each arm of the study in right colon and throughout the entire colon.
- Number of neoplastic lesions for each arm of the study in the right colon and throughout the entire colon and number of neoplastic lesions missed on 1st pass of right colon.
- Proportion of patients with diminutive lesions (< 5 mm) in each arm of the study
- Proportion of patients with Flat lesions (height < 1/2 diameter) in each arm of the study
- Proportion of patients with Sessile Serrated Adenoma in each arm of the study
- Proportion of patients with invasive cancer in each arm of the study
- Presence or absence of learning effect while using this technology given that use of I-Scan may train the human eye to better identify adenomas even without image enhancement.
Read the detailed description
Colorectal Cancer is the third most common cause of cancer in Canada with an estimated lifetime risk of developing the disease of 6-7%. Each year there are approximately 21,000 new cases and 9,100 deaths attributable to this disease. Colonoscopy is one of several methods recommended for Colorectal Cancer (CRC) screening by current guidelines. While colonoscopy is the most invasive, it offers high diagnostic accuracy and ability for therapy (biopsy and removal of adenomas) compared to other modalities. The emerging evidence regarding missed neoplastic lesions with colonoscopy has resulted in quality initiatives designed to improve colonoscopy performance. I-Scan (Pentax, Montvale, NJ) is a new method that uses post processing computer algorithms to revise the standard white light to highlight pit patterns and vascular surface patterns.The relevant I-scan settings in the colon are I-scan 1 and I-scan 2. The primary objective of the study is to compare the adenoma detection rate in the right colon using High-definition white light colonoscopy versus I-scan enhanced colonoscopy.
All patients referred for a screening colonoscopy at Forzani and MacPhail Colon Cancer Centre will be considered for enrollment.All eligible patients that are not part of another research study will be approached for enrollment into the study. During the pre-assessment at the clinic a study assistant will contact all the eligible patients to describe the study and provide an "Invitation to participate in a Research study" form. The study assistant will obtain a final consent if they agree. Those not interested will simply receive the Centre's standard protocol. There will be no coercion of any sort. Following Informed Consent, treatment allocation through computer generated randomization will be revealed. Patients will be allocated to one of the three study arms (HD Colon, I-scan 1 and I-Scan 2). Patients will receive a standard bowel preparation: Split dose Polyethylene Glycol (PEG) (2L at noon + 2L at 8 PM the day before) for morning procedures or (2L at 8Pm the day before and 2L at five hours before the procedure on the day of colonoscopy) for afternoon procedure. certified gastroenterologists will perform all of the procedures with the assistance of a nurse. The planned "second look" of the right colon will involve withdrawing from the Cecum to Hepatic flexure, then re-inserting to Cecum and finally withdrawing through the entire colon. The physician performing the procedure will then fill a "Colonoscopy Report Form" including the number of polyps detected, size, shape, polypectomy method and cleanliness of the bowel.
The investigators did a pilot study with 150 subjects to check the mean no.of adenomas per colonoscopy, no.of adenomas detected in the right colon during the second look and to estimate the recruitment rate. Based on those results the investigators started this study with a large sample size. The investigators are planning to do an interim analysis after recruiting 450 subjects (30% of total enrollment). The results of the analysis will determine whether the investigators complete recruitment of the initially approved sample size of 1500 subjects.
- Conditions
- Colorectal Cancer
- Being tested
- HD Colon, I-scan 1, I-Scan 2
- Keywords
- Colonoscopy, High Definition White Light, I-Scan, Adenomas
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD ColonDevice
High Definition White Light
I-scan 1Device
I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.
I-Scan 2Device
I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE)and Tone Enhancement(TE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities. TE provides a uniform color image and is intended for detailed inspection of distinct lesions.
| Study group | Role | What they receive |
|---|---|---|
| HD Colon | Experimental | High Definition White Light modality will be used by the endoscopist for the entire procedure. Receives: Device: HD Colon |
| I-Scan 1 | Experimental | I-scan 1 modality will be used by the endoscopist for the entire procedure. Receives: Device: I-scan 1 |
| I-Scan 2 | Experimental | I-Scan 2 modality will be used by the endoscopist through out the procedure. Receives: Device: I-Scan 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.
Adenoma Detection Rate is defined as no. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period. The "Colonoscopy Report Form" filled by the Endoscopist helps to assess the number of polyps including an endoscopic description (Location, Size, Shape) of these lesions. Following formal review by the pathologist the polyp classification (eg: Whether it is an adenoma) is determined.
Measured: Colonoscopy report form provided to the Endoscopist will be filled out and collected after the procedure (1hour). All polyps reviewed by pathologist (1 week)
Secondary outcomes (2)
Adenoma Detection Rate (ADR) in the right colon during the "Second Look" irrespective of imaging modality.
The planned "Second Look" of the right colon will involve withdrawing from the cecum to hepatic flexure, then re-inserting to cecum and finally withdrawing through the entire colon. This is to determine if a "Second Look" in the right colon increases the ADR compared with a single inspection irrespective of imaging modality.
Measured: Second look in the right colon and finally withdrawing through the entire colon (approximately 5 min)
Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.
Adenoma Detection Rate is defined as no. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period. The "Colonoscopy Report Form' completed by the Endoscopist helps to assess the number of polyps detected and an endoscopic description (location, shape, size) of these polyps.Following formal review by the pathologist the polyp classification (Eg: wether it is an Adenoma) is determined.
Measured: "Colonoscopy Report Form" provided to the endoscopist will be filled out and collected after the procedure (1 hour). All polyps reviewed by pathologist (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robert Hilsden, University of Calgary
- Investigators
- Dr.Robert Hilsden, MD, Principal investigator, Faculty of Medicine, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016326
- Sponsor's protocol ID
- 23474-M
- Status last verified
- Dec 2013
- First submitted
- 13 Nov 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing High-definition White Light Colonoscopy to I-scan Enhanced Colonoscopy for Adenoma Detection in a Population at Increased Risk of Colorectal Cancer (Main Study)
- ClinicalTrials.gov ID
- NCT02016326
- Acronym / sponsor ID
- 23474-M
- Conditions
- Colorectal Cancer
- Keywords
- Colonoscopy, High Definition White Light, I-Scan, Adenomas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- 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.
The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.
Primary Outcome:
Adenoma Detection Rate (ADR - No. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.
Secondary Outcomes:
- Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.
- Adenoma Detection Rate (ADR) in the right colon during the "Second look", irrespective of imaging modality.
- Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were found(regardless of the histological type) divided by the total no. of colonoscopies performed in the Same time period) for each arm of the study in Right colon and throughout the entire colon.
- Mean number of adenomas per procedure for each arm of the study in right colon and throughout the entire colon.
- Mean number of polyps per procedure for each arm of the study in right colon and throughout the entire colon.
- Number of neoplastic lesions for each arm of the study in the right colon and throughout the entire colon and number of neoplastic lesions missed on 1st pass of right colon.
- Proportion of patients with diminutive lesions (< 5 mm) in each arm of the study
- Proportion of patients with Flat lesions (height < 1/2 diameter) in each arm of the study
- Proportion of patients with Sessile Serrated Adenoma in each arm of the study
- Proportion of patients with invasive cancer in each arm of the study
- Presence or absence of learning effect while using this technology given that use of I-Scan may train the human eye to better identify adenomas even without image enhancement.
Detailed description
Colorectal Cancer is the third most common cause of cancer in Canada with an estimated lifetime risk of developing the disease of 6-7%. Each year there are approximately 21,000 new cases and 9,100 deaths attributable to this disease. Colonoscopy is one of several methods recommended for Colorectal Cancer (CRC) screening by current guidelines. While colonoscopy is the most invasive, it offers high diagnostic accuracy and ability for therapy (biopsy and removal of adenomas) compared to other modalities. The emerging evidence regarding missed neoplastic lesions with colonoscopy has resulted in quality initiatives designed to improve colonoscopy performance. I-Scan (Pentax, Montvale, NJ) is a new method that uses post processing computer algorithms to revise the standard white light to highlight pit patterns and vascular surface patterns.The relevant I-scan settings in the colon are I-scan 1 and I-scan 2. The primary objective of the study is to compare the adenoma detection rate in the right colon using High-definition white light colonoscopy versus I-scan enhanced colonoscopy.
All patients referred for a screening colonoscopy at Forzani and MacPhail Colon Cancer Centre will be considered for enrollment.All eligible patients that are not part of another research study will be approached for enrollment into the study. During the pre-assessment at the clinic a study assistant will contact all the eligible patients to describe the study and provide an "Invitation to participate in a Research study" form. The study assistant will obtain a final consent if they agree. Those not interested will simply receive the Centre's standard protocol. There will be no coercion of any sort. Following Informed Consent, treatment allocation through computer generated randomization will be revealed. Patients will be allocated to one of the three study arms (HD Colon, I-scan 1 and I-Scan 2). Patients will receive a standard bowel preparation: Split dose Polyethylene Glycol (PEG) (2L at noon + 2L at 8 PM the day before) for morning procedures or (2L at 8Pm the day before and 2L at five hours before the procedure on the day of colonoscopy) for afternoon procedure. certified gastroenterologists will perform all of the procedures with the assistance of a nurse. The planned "second look" of the right colon will involve withdrawing from the Cecum to Hepatic flexure, then re-inserting to Cecum and finally withdrawing through the entire colon. The physician performing the procedure will then fill a "Colonoscopy Report Form" including the number of polyps detected, size, shape, polypectomy method and cleanliness of the bowel.
The investigators did a pilot study with 150 subjects to check the mean no.of adenomas per colonoscopy, no.of adenomas detected in the right colon during the second look and to estimate the recruitment rate. Based on those results the investigators started this study with a large sample size. The investigators are planning to do an interim analysis after recruiting 450 subjects (30% of total enrollment). The results of the analysis will determine whether the investigators complete recruitment of the initially approved sample size of 1500 subjects.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HD Colon | Experimental | Device: HD ColonHigh Definition White Light modality will be used by the endoscopist for the entire procedure. |
| I-Scan 1 | Experimental | Device: I-scan 1I-scan 1 modality will be used by the endoscopist for the entire procedure. |
| I-Scan 2 | Experimental | Device: I-Scan 2I-Scan 2 modality will be used by the endoscopist through out the procedure. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All increased risk patients (Patients with family history or personal history of colon polyps or colon cancer and FOBT positive) referred for a screening colonoscopy at the Forzani and MacPhail Colon Cancer Screening Centre will be considered for enrollment.
Key exclusion criteria (4 listed)
- Average Risk patients
- Previous colon surgery
- Hereditary Polyposis Syndromes
- Suspected polyps or CRC before colonoscopy that have been suggested by another modality (Barium Enema, Virtual Colonoscopy, Flexible Sigmoidoscopy)
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 |
|---|---|---|
| HD ColonHigh Definition White Light | Device | HD Colon |
| I-scan 1I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities. | Device | I-Scan 1 |
| I-Scan 2I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE)and Tone Enhancement(TE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities. TE provides a uniform color image and is intended for detailed inspection of distinct lesions. | Device | I-Scan 2 |
Primary outcome
Adenoma Detection Rate (ADR) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.
Time frame: Colonoscopy report form provided to the Endoscopist will be filled out and collected after the procedure (1hour). All polyps reviewed by pathologist (1 week)
Adenoma Detection Rate is defined as no. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period. The "Colonoscopy Report Form" filled by the Endoscopist helps to assess the number of polyps including an endoscopic description (Location, Size, Shape) of these lesions. Following formal review by the pathologist the polyp classification (eg: Whether it is an adenoma) is determined.
2 secondary outcomes
Adenoma Detection Rate (ADR) in the right colon during the "Second Look" irrespective of imaging modality.
Time frame: Second look in the right colon and finally withdrawing through the entire colon (approximately 5 min)
Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.
Time frame: "Colonoscopy Report Form" provided to the endoscopist will be filled out and collected after the procedure (1 hour). All polyps reviewed by pathologist (1 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Dr.Robert Hilsden, MD principal investigator
Faculty of Medicine, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD Colon, I-scan 1 and I-Scan 2 in people with Colorectal Cancer, run by University of Calgary at 1 site in Canada.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Dec 2013. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Steven Heitman, MD ((403)592-5020, steven.heitman@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (ADR) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy. (time frame: Colonoscopy report form provided to the Endoscopist will be filled out and collected after the procedure (1hour). All polyps reviewed by pathologist (1 week)). 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 19 Dec 2013.