Computed Tomographic Colonography in Screening Healthy Participants for Colorectal Cancer (ACRIN 6664)
RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection.
PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||National CT Colonography Trial|
- Sensitivity [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]Evaluate the sensitivity of CT colonography for detecting participants with at least one proved clinically significant large lesion (at least 10 mm in diameter), using colonoscopy as the reference standard.
- Interobserver variation in accuracy [ Time Frame: 1 Day ] [ Designated as safety issue: No ]Evaluate interobserver variation in accuracy of interpreting CTC examinations, including any benefits of 1) a primary 3D read and/or 2) independent second interpretations.
- Additional secondary outcome measures [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
- To develop a well-annotated database of CTC case materials for future study. Data appropriate for computed-aided diagnosis development will be collected for this purpose. This data, subject to ACRIN Image Archive policies, will be made available to the image processing and clinical community. Availability of CTC case materials may be via the internet.
- To assess the cost-effectiveness of CTC compared to other CRC screening tests.
- Descriptive outcomes [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
- To describe the effects of different colon preparations, as ordered by the referring gastroenterologist, on accuracy of CTC.
- To describe patient acceptance of CT colonography and their willingness to have a repeat examination in comparison to optical colonoscopy.
- To describe the various morphologic features, distribution, and frequency of flat colonic lesions, and to estimate the accuracy of CTC in detecting flat lesions in the colon.
- To describe the prevalence and clinical significance of extracolonic abnormalities detected in the course of a CTC examination.
- To describe the various methods of CTC evaluation and assess differences in software platforms by evaluating user preferences and performance differences, including evaluation times.
|Study Start Date:||February 2005|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Experimental: CT Colonography
CT colonography conducted during the same assessment as colonoscopy.
Procedure: CT Colonography
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
- 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 participants.
- Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy.
- Determine the accuracy of CTC in detecting flat lesions in the colon of these participants.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084929
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, California|
|Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093-0658|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Veterans Affairs Medical Center - San Francisco|
|San Francisco, California, United States, 94121|
|United States, Colorado|
|Invision/Radiology Imaging Associates - Englewood|
|Englewood, Colorado, United States, 80112|
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Clinical Radiologists, S.C. at Memorial Medical Center|
|Springfield, Illinois, United States, 62781|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Mallinckrodt Institute of Radiology at Washington University Medical Center|
|St. Louis, Missouri, United States, 63110|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0037|
|Study Chair:||C. Daniel Johnson, MD||Mayo Clinic|