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Completed

NCT Number: NCT01399710

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT colonography

Procedure

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.

colonoscopy

Procedure

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

CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy

Device

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.

Primary outcomes

  1. Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm

  2. Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions

Secondary outcomes

  1. Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger

  2. Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger

Sponsors and collaborators

Lead sponsor

im3D S.p.A.

Other

Collaborators

  • Bicocca Universiy of Milano, Milan, Italy
  • Candiolo Cancer Institute - IRCCS
  • Catholic University, Italy
  • Fondazione Salvatore Maugeri
  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Nuovo Regina Margherita Hospital
  • University of Florence
  • University of Pisa
  • University of Roma La Sapienza
  • University of Turin, Italy
  • Valduce Hospital

Registry information

Official study title

Measure of Performances of CT Colonography With Computer-Aided Detection (CAD) as Second Reader in Detecting Colorectal Lesion

Acronym: CAD-IMPACT

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jul 22, 2011
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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