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

PHASE3CompletedINTERVENTIONAL
Enrollment

651

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

May 31, 2009

Study Completion Date

March 31, 2010

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.

All Listed Sponsors
collaborator

Candiolo Cancer Institute - IRCCS

OTHER

collaborator

Bicocca Universiy of Milano, Milan, Italy

UNKNOWN

collaborator

Fondazione Salvatore Maugeri

OTHER

collaborator

Catholic University, Italy

OTHER

collaborator

Valduce Hospital

OTHER

collaborator

University of Turin, Italy

OTHER

collaborator

University of Roma La Sapienza

OTHER

collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

collaborator

Nuovo Regina Margherita Hospital

OTHER

collaborator

University of Pisa

OTHER

collaborator

University of Florence

OTHER

collaborator

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

OTHER

lead

im3D S.p.A.

OTHER

NCT01399710 - Impact of Computer-Aided Detection (CAD) as Second Reader in CT Colonography | Biotech Hunter | Biotech Hunter