Status:

COMPLETED

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

Lead Sponsor:

im3D S.p.A.

Collaborating Sponsors:

Candiolo Cancer Institute - IRCCS

Bicocca Universiy of Milano, Milan, Italy

Conditions:

Individuals With Suspected Colorectal Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 prom...

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 colo...

Eligibility Criteria

Inclusion

  • \- clinical indication to undergo colonoscopy either for symptoms, or participating a surveillance program or a CRC screening

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

651 Patients enrolled

Trial Details

Trial ID

NCT01399710

Start Date

July 1 2007

End Date

March 1 2010

Last Update

July 22 2011

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