Colorectal polyps
Conditions
Interventions
- CT colonography performed without laxative bowel preparation
- Standard optical colonoscopy
Sponsors
Okamoto Masaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be at least 40 years of age at the time of signing the informed consent form (ICF). 2. Participants who tested positive for fecal occult blood within the past year or are suspected of having a colorectal neoplastic lesion and have been deemed by a physician to be candidates for outpatient colonoscopy.
Exclusion criteria
Exclusion criteria: 1. Confirmed presence of colorectal cancer. 2. Confirmed diagnosis of inflammatory gastrointestinal diseases, such as gastrointestinal ulcers, appendicitis, diverticulitis, or ulcerative colitis. 3. Confirmed diagnosis of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome), based on Amsterdam criteria. 4. Presence of clear risk factors for undergoing colonoscopy. 5. History of colorectal resection. 6. Suspected gastrointestinal stenosis, intestinal obstruction, intestinal perforation, or toxic megacolon. 7. Considered to be at high risk for CT colonography and associated bowel preparation, including but not limited to: - Individuals who are unable to follow instructions during the examination due to conditions such as claustrophobia or hearing impairment. - Individuals with a history of hypersensitivity to iodine-based or barium-based contrast agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity (per-lesion) for detecting colorectal polyps 6 mm or more on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy serving as the reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Sensitivity and specificity (per-patient) for detecting colorectal polyps 6 mm or more, based on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy as the reference standard. - Sensitivity and specificity (per-patient) for detecting colorectal polyps 10 mm or more, based on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy as the reference standard. - Positive predictive value (per-lesion) for colorectal polyps 6 mm or more exceeding 0.72, based on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy as the reference standard. - Sensitivity and positive predictive value (per-lesion) for colorectal polyps 10 mm or more, based on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy as the reference standard. - Clinical effectiveness of the Electronic Cleansing function provided by AIM4CRC. | — |
Contacts
Public ContactMasahiro Echigo
Boston Medical Sciences, Inc.
Outcome results
None listed