Clinical trial · Interventional
Evaluation of Computer-assisted, Non-cathartic CT Colonography
Prospective Evaluation of Computer-Assisted, Non-Cathartic CT Colonography for Detection of Adenomatous Colonic Polyps in a Screening Cohort
NCT01200303CI-TRIAL-00018760ncCTCcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the performance of a non-cathartic, computer-assisted form of CT Colonography (Virtual Colonoscopy) for detection of pre-cancerous colon polyps in a group of asymptomatic screening patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non-cathartic CTC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- non-cathartic CTC and OC
- description
- This is a single arm, open label, prospective test comparison of non-cathartic, CAD-assisted CTC to segmentally unblinded optical colonoscopy (OC). All study subjects receive both tests, starting with CTC, followed by OC within 5 weeks. CTC results are recorded and revealed to endoscopist on a segment-by-segment basis after initial (blinded) OC evaluation; endoscopist can double check / confirm lesion presence after unblinding and this second read serves as reference standard.
- interventionNames
- Procedure: non-cathartic CTC
Primary outcomes (1)
- measure
- Performance for detection of adenomatous colonic polyps > 6mm
- timeFrame
- on per subject basis, metric will be assessed at unblinding OC (w/i 5 weeks enrollment); for cohort, summary statistics will be generated at study completion
- description
- this is a prospective test comparison of non-cathartic, CAD-assisted CT Colonography to segmentally unblinded optical colonoscopy (OC), latter serving with pathology specimens as reference standard for presence of polyps.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * age 50-80, eligible for colon screening Exclusion Criteria: * prior anatomic colon screening exam (optical colonoscopy, sigmoidoscopy, barium enema, CT Colonography) within last 5 years * personal history of inflammatory bowel disease, polyposis syndrome, colo-rectal cancer, colon surgery * documented passage of blood per rectum within last 12 months
References
Publications (1)
- RESULTZalis ME, Blake MA, Cai W, Hahn PF, Halpern EF, Kazam IG, Keroack M, Magee C, Nappi JJ, Perez-Johnston R, Saltzman JR, Vij A, Yee J, Yoshida H. Diagnostic accuracy of laxative-free computed tomographic colonography for detection of adenomatous polyps in asymptomatic adults: a prospective evaluation. Ann Intern Med. 2012 May 15;156(10):692-702. doi: 10.7326/0003-4819-156-10-201205150-00005. PMID 22586008