NCT00084929

The National CT Colonography Trial

The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,600 (actual)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	CT Colonography	CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-09-11
• Completion: 2010-05-13
• First posted: 2004-06-11
• Last updated: 2020-12-22
• Results posted: 2020-11-16

Locations

14 sites across 1 country: United States