Unprepped CT Colonography

Completed

• Conditions: Colorectal Neoplasms

• Registration Number: NCT00586053
• Lead Sponsor: Mayo Clinic

Brief Summary

It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.

Detailed Description

To improve the diagnostic performance of CTC in the prepared colon using improved spatial resolution, advanced image displays, and computer-assisted diagnosis, and to optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. To estimate the sensitivity and specificity of CTC in the unprepared colon for clinically important colorectal neoplasms (large adenomas ≥ 1 cm) and to compare such estimates with colonoscopy. To survey patient acceptance of CTC in the unprepared colon, and to assess implications for health care costs and cost-effectiveness of CTC in the unprepared colon in comparison with other approaches.

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-03
• Study First Posted: 2008-01-04
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-10
• Last Update Posted: 2010-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1255

Inclusion Criteria

Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications:

• Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.
• Age ≥ 40 -100 years
• Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160)
• Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.

Exclusion Criteria

• Less than 1/2 of colorectum remaining
• Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis)
• Familial Polyposis
• Melena, hematochezia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques.	2000-2009

Secondary Outcome Measures

Name	Time	Method
The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests	2000-2009

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States