Evaluation of Computer-assisted, Non-cathartic CT Colonography

Colonic Polyps Clinical Trial

— ncCTC  

Official title:

Prospective Evaluation of Computer-Assisted, Non-Cathartic CT Colonography for Detection of Adenomatous Colonic Polyps in a Screening Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200303
• Other study ID #: GEH-03-OPQ-001
• Secondary ID: ACS 116256-RSG-0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2010
• Last updated: August 3, 2015
• Start date: June 2005
• Est. completion date: January 2011

Study information

• Verified date: August 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the performance of a non-cathartic, computer-assisted form of CT Colonography (Virtual Colonoscopy) for detection of pre-cancerous colon polyps in a group of asymptomatic screening patients.

Description:

Examinations to completely assess the colonic anatomy for the purposes of polyp detection and cancer prevention all require an unpleasant, pre-exam cathartic bowel preparation. The discomfort and embarrassment associated with this bowel prep has been identified as a barrier to adherence of at-risk subjects with recommended colon screening guidelines. CT Colonography (CTC) is an imaging based test that evaluates the entire colon anatomy and requires cathartic bowel prep; its performance is considered comparable to optical colonoscopy (OC) for adenomatous polyp detection. In addition, CTC generates a large amount of data to be read by a human, and this data interpretation task can be aided by computer-assisted-detection (CAD) software to identify potential polyp lesions for the human reviewer. This trial studies the performance of a form of CTC that uses fecal tagging and electronic image cleansing to obviate the need for cathartic prep. In addition, readings prospectively employ CAD to potentially buffer human interpretation performance. The investigators are prospectively testing this augmented (non-cathartic, CAD-assisted) form of CTC in asymptomatic (screening) cohort. The trial is a prospective test comparison, using segmentally unblinded optical colonoscopy in combination with pathology specimens as a reference standard for presence of target lesions, adenomatous polyps 6 mm or greater in size.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 50-80, eligible for colon screening

Exclusion Criteria:

• prior anatomic colon screening exam (optical colonoscopy, sigmoidoscopy, barium enema, CT Colonography) within last 5 years

• personal history of inflammatory bowel disease, polyposis syndrome, colo-rectal cancer, colon surgery

• documented passage of blood per rectum within last 12 months

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps

Intervention

Procedure:
• non-cathartic CTC
non-cathartic, CAD-assisted CT Colonography

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	UCSF-VA Medical Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Cancer Society, Inc., GE Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zalis ME, Blake MA, Cai W, Hahn PF, Halpern EF, Kazam IG, Keroack M, Magee C, Näppi JJ, Perez-Johnston R, Saltzman JR, Vij A, Yee J, Yoshida H. Diagnostic accuracy of laxative-free computed tomographic colonography for detection of adenomatous polyps in a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance for detection of adenomatous colonic polyps > 6mm	this is a prospective test comparison of non-cathartic, CAD-assisted CT Colonography to segmentally unblinded optical colonoscopy (OC), latter serving with pathology specimens as reference standard for presence of polyps.	on per subject basis, metric will be assessed at unblinding OC (w/i 5 weeks enrollment); for cohort, summary statistics will be generated at study completion	No
Secondary	Patient comfort associated with non-cathartic exam preparation	as part of the prospective test comparison, we are generating summary statistics of self-reported patient comfort assessments with the test (non-cathartic) exam preparation versus standard, cathartic preparation.	on per subject basis, outcome will be assessed at 5 weeks post enrollment (following OC); for cohort, summary statistics will be generated at study completion	No