I-Scan Vs High Definition White Light (Main Study)

NCT02016326 | Unknown

• 1 other identifier: 23474-M
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colorectal Cancer

Keywords

Colonoscopy; High Definition White Light; I-Scan; Adenomas

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  "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)

Other Outcomes (1)

• Presence or absence of learning effect while using this technology

  12-18 months

Study Arms (3)

HD Colon

EXPERIMENTAL

High Definition White Light modality will be used by the endoscopist for the entire procedure.

Device: HD Colon

I-Scan 1

EXPERIMENTAL

I-scan 1 modality will be used by the endoscopist for the entire procedure.

Device: I-scan 1

I-Scan 2

EXPERIMENTAL

I-Scan 2 modality will be used by the endoscopist through out the procedure.

Device: I-Scan 2

Interventions

HD Colon DEVICE

High Definition White Light

HD Colon

I-scan 1 DEVICE

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 1

I-Scan 2 DEVICE

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.

I-Scan 2

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Dr.Robert Hilsden, MD

  Faculty of Medicine, University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Steven Heitman, MD

CONTACT

(403)592-5020; steven.heitman@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine & Research Director, Colon Cancer Screening Centre

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: December 19, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

CA (1)