NCT00997802

Japanese National Computed Tomographic (CT) Colonography Trial

Evaluation of Accuracy of Computed Tomographic Colonography (CTC) in the Diagnosis of Colorectal Tumors by Gastroenterologists and Radiologists With Computer-aided Detection (CAD): A Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,257 (actual)
• Sponsor: Japanese CT Colonography Society · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the sensitivity of computed tomographic colonography (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard.

Detailed description

The investigators will evaluate the sensitivity of CTC in detecting colorectal polyps and cancers (at least 6 mm in diameter) in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard. The primary endpoint will be sensitivity in the detection of colorectal polyps and cancers that are at least 6 mm in diameter. The secondary endpoints will include specificity and predictive values in the detection of colorectal polyps and cancers. This clinical study will also evaluate the differences of the detection accuracies between human readings with and without computer-aided detection (CAD) that automatically detects colonic lesions in CTC images and presents the detected lesions to the readers. This clinical study will also compare performance between radiologists and gastroenterologists in detecting colorectal lesions in CTC images. All the CTC images and their interpretations, optical colonoscopy reports and images, and pathology reports of resected colorectal lesion will be prospectively collected from 12 Japanese hospitals participating in the trial. All patients' information will be completely anonymized at each site before any analysis of the data takes place.

Conditions

• Colonic Polyps
• Colonic Neoplasms

Interventions

Type	Name	Description
DEVICE	CT colonography and optical colonoscopy	All patients will undergo CT colonography and optical colonoscopy.

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-12-11
• Completion: 2017-01-01
• First posted: 2009-10-19
• Last updated: 2017-03-17

Locations

12 sites across 2 countries: United States, Japan