Clinical trial NCT01200303: Evaluation of Computer-assisted, Non-cathartic CT Colonography
Official title: Prospective Evaluation of Computer-Assisted, Non-Cathartic CT Colonography for Detection of Adenomatous Colonic Polyps in a Screening Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colonic Polyps
Keywords: colon cancer
adenomatous colonic polyps
colon screening
CT Colonography (Virtual Colonoscopy)
Computer Aided Detection
Electronic Cleansing
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: GE Healthcare
name: American Cancer Society, Inc.
First posted: 2010-09-13
Enrollment: 605
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Performance for detection of adenomatous colonic polyps > 6mm
timeFrame: 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
Secondary outcomes:
measure: Patient comfort associated with non-cathartic exam preparation
timeFrame: 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
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF-VA Medical Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Michael Zalis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zalis ME, Blake MA, Cai W, Hahn PF, Halpern EF, Kazam IG, Keroack M, Magee C, Nappi 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 asymptomatic adults: a prospective evaluation. Ann Intern Med. 2012 May 15;156(10):692-702. doi: 10.7326/0003-4819-156-10-201205150-00005.