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Evaluation of Computer-assisted, Non-cathartic CT Colonography (ncCTC)

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ClinicalTrials.gov Identifier: NCT01200303
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : August 5, 2015
Sponsor:
Collaborators:
GE Healthcare
American Cancer Society, Inc.
Information provided by (Responsible Party):
Michael Zalis MD, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Procedure: non-cathartic CTC Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2005
Actual Primary Completion Date : October 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200303


Locations
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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
Sponsors and Collaborators
Massachusetts General Hospital
GE Healthcare
American Cancer Society, Inc.
Investigators
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Principal Investigator: Michael Zalis, MD Massachusetts General Hospital
More Information
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Publications of Results:

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Responsible Party: Michael Zalis MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01200303    
Other Study ID Numbers: GEH-03-OPQ-001
ACS 116256-RSG-08-221-01-CCE ( Other Grant/Funding Number: American Cancer Society )
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Keywords provided by Michael Zalis MD, Massachusetts General Hospital:
colon cancer
adenomatous colonic polyps
colon screening
 CT Colonography (Virtual Colonoscopy)
Computer Aided Detection
Electronic Cleansing
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps