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

Phase 3

Completed

• Conditions: Individuals With Suspected Colorectal Disease

• Registration Number: NCT01399710
• Lead Sponsor: im3D S.p.A.

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.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2009-05
• Study Completion: 2010-03
• Status Verified: 2011-07
• Study First Submitted: 2011-07-15
• Study First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Study First Posted: 2011-07-22
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 651

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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