Evaluation of Computer-assisted, Non-cathartic CT Colonography (ncCTC)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonic Polyps |
Procedure: non-cathartic CTC |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 610 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | January 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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Procedure: non-cathartic CTC
non-cathartic, CAD-assisted CT Colonography
Other Name: tagging of non-cathartic CTC employs iohexol (Omnipaque 300)
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Detailed 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.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| UCSF-VA Medical Center | |
| San Francisco, California, United States, 94121 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Michael Zalis, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Michael Zalis MD--Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01200303 History of Changes |
| Other Study ID Numbers: | GEH-03-OPQ-001, ACS 116256-RSG-08-221-01-CCE |
| Study First Received: | September 9, 2010 |
| Last Updated: | December 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
colon cancer adenomatous colonic polyps colon screening |
CT Colonography (Virtual Colonoscopy) Computer Aided Detection Electronic Cleansing |
Additional relevant MeSH terms:
|
Colonic Polyps Polyps Intestinal Polyps Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013