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

im3D

Status and phase: Completed; Phase 3

Conditions: Individuals With Suspected Colorectal Disease

Treatments: Device: CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy; Procedure: CT colonography; Procedure: colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01399710

CAD COLON 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 651 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)