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

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.

Conditions

• Individuals With Suspected Colorectal Disease

Interventions

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.

Sponsors & Collaborators

• Candiolo Cancer Institute - IRCCS

  collaborator OTHER

• Bicocca Universiy of Milano, Milan, Italy

  collaborator UNKNOWN

• Fondazione Salvatore Maugeri

  collaborator OTHER

• Catholic University, Italy

  collaborator OTHER

• Valduce Hospital

  collaborator OTHER

• University of Turin, Italy

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• Nuovo Regina Margherita Hospital

  collaborator OTHER

• University of Pisa

  collaborator OTHER

• University of Florence

  collaborator OTHER

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

  collaborator OTHER

• im3D S.p.A.

  lead OTHER

Principal Investigators

• Daniele Regge · Institute Institute for Cancer Research and Treatment, Candiolo, Italy

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2009-05-31

Completion

2010-03-31