colorectal cancer, colorectal polyp
Conditions
Interventions
Sponsors
Japanese CTC Society
Showa University Northern Yokohama Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Outpatients who are eligible for optical colonoscopy. 2) Aged 20 years or older. 3) Major functions of organs of the subjects are in a good condition. 4) Signed informed consent forms are obtained by the patients.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CTC vs. optical colonoscopy. Detection performance and accuracy of colorectal polyps (at least 6 mm in diameter) and colorectal cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKoichi Nagata
Massachusetts General Hospital and Harvard Medical School 3D Imaging Laboratory, Department of Radiology
Outcome results
None listed