Impact of Computer-Aided Detection (CAD) as Second Reader in CT Colonography

Study Overview
=================
Brief Summary
-----------------
RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD) has shown promising results in providing uniform accuracy and improving CT colonography sensitivity. PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and CAD-assisted reading in detecting patients with colorectal lesions.

Detailed Description
-----------------
Design: multicenter, cross-sectional study. Each participant underwent CT colonography and colonoscopy on the same day. Expert readers interpreted CT colonography unassisted and then reviewed all colorectal lesion-like structures pinpointed by the CAD algorithm.

Official Title
-----------------
Measure of Performances of CT Colonography With Computer-Aided Detection (CAD) as Second Reader in Detecting Colorectal Lesion

Conditions
-----------------
Individuals With Suspected Colorectal Disease

Intervention / Treatment
-----------------
* Procedure: CT colonography
* Procedure: colonoscopy
* Device: CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - clinical indication to undergo colonoscopy either for symptoms, or participating a surveillance program or a CRC screening Exclusion Criteria: clinical diagnosis of familial adenomatous polyposis or hereditary nonpolyposis CRC syndrome inflammatory bowel disease celiac disease evidence of increased risk of harm from colonoscopy psychological or physical conditions that contraindicated colonoscopy or CT Colonography

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: CT colonography|Participants were placed on a CT table and a small flexible rectal catheter was positioned. N-butyl-scopolamine was administered intravenously if this was common practice in the participating center. Immediately before scanning, pneumocolon was obtained through insufflation of room air or carbon dioxide, either manually by means of a balloon pump or with an automatic device, until maximum tolerance was reached. CT colonography was performed with the participant in supine and prone positions with the following scanning protocol: 120 kilovolt peak (kVp), 50 or fewer effective mA per second, and a section thickness not greater than 1.25 mm.|
|Procedure: colonoscopy|Colonoscopy was performed at least 3 hours after CT colonography. The endoscope was advanced to the cecum and the entire length of the bowel was examined during endoscope withdrawal. The endoscopist was initially blinded to the result of CT colonography; at the end of each bowel segment evaluation, CT colonography results for that segment were disclosed (segmental unblinding). If a lesion measuring 6 mm or larger was detected at CT colonography but not at colonoscopy, the segment was reexamined to resolve the discrepancy|
|Device: CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy|Each CT colonography study was read in two phases. In the first phase the radiologist interpreted the examination without activating the CAD algorithm. This phase of reporting was defined as unassisted reading. Then the radiologist activated the CAD algorithm which pinpointed a series of colorectal lesion-like structures (i.e. lesion candidates) on both the prone and supine acquisition. All lesion candidates were examined. The second phase of reporting was defined as CAD-assisted reading.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm |  |  | 
| Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger |  |  | 
| Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, CT colonography, CAD