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The purpose of this study is to evaluate the sensitivity of 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.
We 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, Control: Active Control, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
CT colonography and optical colonoscopy
Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital
Japanese CT Colonography Society
Published on BioPortfolio: 2014-07-24T14:11:11-0400
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Discrete tissue masses that protrude into the lumen of the COLON. These POLYPS are connected to the wall of the colon either by a stalk, pedunculus, or by a broad base.
The use of light interaction (scattering, absorption, and fluorescence) with biological tissue to obtain morphologically based information. It includes measuring inherent tissue optical properties such as scattering, absorption, and autofluorescence; or optical properties of exogenous targeted fluorescent molecular probes such as those used in optical MOLECULAR IMAGING, or nontargeted optical CONTRAST AGENTS.
A variant of ADENOMATOUS POLYPOSIS COLI caused by mutation in the APC gene (GENES, APC) on CHROMOSOME 5. It is characterized by not only the presence of multiple colonic polyposis but also extracolonic ADENOMATOUS POLYPS in the UPPER GASTROINTESTINAL TRACT; the EYE; the SKIN; the SKULL; and the FACIAL BONES; as well as malignancy in organs other than the GI tract.
Inflammation of the COLONIC DIVERTICULA, generally with abscess formation and subsequent perforation.
Chronic or recurrent colonic disorders without an identifiable structural or biochemical explanation. The widely recognized IRRITABLE BOWEL SYNDROME falls into this category.
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