Evaluation of accuracy of computed tomographic colonography (CTC) in the diagnosis of colorectal tumor by gastroenterologists and radiologists with computer-aided detection (CAD): A multicenter study

Not Applicable

• Conditions: colorectal cancer, colorectal polyp

• Registration Number: JPRN-UMIN000002097
• Lead Sponsor: Japanese CTC Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-20
• Study Completion: 2012-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

1) Known colorectal polyps or cancers at any site at the time of enrollment. 2) Patients with inflammatory bowel disease. 3) Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria). 4) Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit. 5) Previous colorectal surgery. 6) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon. 7) Evidence of an increased risk in carrying out bowel preparation or CTC exams. 8) Possibility of pregnancy. 9) Optical colonoscopy or barium enema carried out within the last 3 years. 10) Patients with psychological conditions that contraindicate colonoscopy or make them irrelevant to participate in the trial. 11) Iodine hypersensitivity. 12) Severe thyroid disease. 13) Claustrophobia. 14) Severe deafness. 15) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CTC vs. optical colonoscopy. Detection performance and accuracy of colorectal polyps (at least 6 mm in diameter) and colorectal cancer.

Secondary Outcome Measures

Name	Time	Method
The differences of detection performance of human readings without and with CAD. Diagnostic performances between radiologists and gastroenterologists. Comparative adherence of patients to CTC and optical colonoscopy. Frequency and nature of any adverse events.