Evaluation of Computer-assisted, Non-cathartic CT Colonography (ncCTC)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Prospective Evaluation of Computer-Assisted, Non-Cathartic CT Colonography for Detection of Adenomatous Colonic Polyps in a Screening Cohort|
- Performance for detection of adenomatous colonic polyps > 6mm [ Time Frame: 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 ] [ Designated as safety issue: No ]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.
- Patient comfort associated with non-cathartic exam preparation [ Time Frame: 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2005|
|Study Completion Date:||January 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Active Comparator: non-cathartic CTC and OC
This is a single arm, open label, prospective test comparison of non-cathartic, CAD-assisted CTC to segmentally unblinded optical colonoscopy (OC). All study subjects receive both tests, starting with CTC, followed by OC within 5 weeks. CTC results are recorded and revealed to endoscopist on a segment-by-segment basis after initial (blinded) OC evaluation; endoscopist can double check / confirm lesion presence after unblinding and this second read serves as reference standard.
Procedure: non-cathartic CTC
non-cathartic, CAD-assisted CT Colonography
Other Name: tagging of non-cathartic CTC employs iohexol (Omnipaque 300)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200303
|United States, California|
|UCSF-VA Medical Center|
|San Francisco, California, United States, 94121|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Michael Zalis, MD||Massachusetts General Hospital|