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
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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
sensitivity in the detection of colorectal polyps and cancers in CTC
Koichi Nagata, MD, PhD
Japanese CTC Society
United States: Institutional Review Board
|Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital||Boston, Massachusetts 02114|