non-cathartic CTC
Procedurenon-cathartic, CAD-assisted CT Colonography
Other names: tagging of non-cathartic CTC employs iohexol (Omnipaque 300)
NCT Number: NCT01200303
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.
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Notify Me50 year–80 year
All sexes
Interventional
Phase 2 / Phase 3
UCSF-VA Medical Center, San Francisco, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
non-cathartic, CAD-assisted CT Colonography
Other names: tagging of non-cathartic CTC employs iohexol (Omnipaque 300)
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
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.
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
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.
Massachusetts General Hospital
Other
Prospective Evaluation of Computer-Assisted, Non-Cathartic CT Colonography for Detection of Adenomatous Colonic Polyps in a Screening Cohort
Acronym: ncCTC
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