National CT Colonography Trial
- Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for
detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic
participants, in terms of specificity, area under the ROC curve, and predictive values
for detecting clinically significant colorectal neoplasia.
- Determine the interobserver variation in accuracy of interpreting CTC examinations of
these participants, including any benefits of a primary 3-dimensional read and/or
independent second interpretations.
- Determine the effects of different colon preparations on the accuracy of CTC in these
- Compare participant acceptance and willingness to have a repeat examination by CTC vs
- Determine the accuracy of CTC in detecting flat lesions in the colon of these
OUTLINE: This is a multicenter study.
Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium
sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed
tomographic colonography followed by colonoscopy.
Participants are followed up for approximately 4 weeks.
PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.
Masking: Open Label, Primary Purpose: Screening
C. Daniel Johnson, MD
United States: Federal Government
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Veterans Affairs Medical Center - San Francisco||San Francisco, California 94121|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|Yale Cancer Center||New Haven, Connecticut 06520-8028|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Virginia Commonwealth University Massey Cancer Center||Richmond, Virginia 23298-0037|
|Moores UCSD Cancer Center||La Jolla, California 92093-0658|
|Mallinckrodt Institute of Radiology at Washington University Medical Center||St. Louis, Missouri 63110|
|Invision/Radiology Imaging Associates - Englewood||Englewood, Colorado 80112|
|Clinical Radiologists, S.C. at Memorial Medical Center||Springfield, Illinois 62781|