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

This study has been completed.
Sponsor:
Collaborators:
Institute for Cancer Research and Treatment, Candiolo, Italy
Bicocca Universiy of Milano, Milan, Italy
Fondazione Salvatore Maugeri
Catholic University, Italy
Valduce Hospital
University of Turin, Italy
University of Roma La Sapienza
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Nuovo Regina Margherita Hospital
University of Pisa
University of Florence
National Cancer Institute, Aviano, Italy
Information provided by:
im3D S.p.A.
ClinicalTrials.gov Identifier:
NCT01399710
First received: July 15, 2011
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Individuals With Suspected Colorectal Disease
Procedure: CT colonography
Procedure: colonoscopy
Device: CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Measure of Performances of CT Colonography With Computer-Aided Detection (CAD) as Second Reader in Detecting Colorectal Lesion

Resource links provided by NLM:


Further study details as provided by im3D S.p.A.:

Primary Outcome Measures:
  • Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm [ Designated as safety issue: No ]
  • Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger [ Designated as safety issue: No ]
  • Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger [ Designated as safety issue: No ]

Enrollment: 651
Study Start Date: July 2007
Study Completion Date: March 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399710

Sponsors and Collaborators
im3D S.p.A.
Institute for Cancer Research and Treatment, Candiolo, Italy
Bicocca Universiy of Milano, Milan, Italy
Fondazione Salvatore Maugeri
Catholic University, Italy
Valduce Hospital
University of Turin, Italy
University of Roma La Sapienza
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Nuovo Regina Margherita Hospital
University of Pisa
University of Florence
National Cancer Institute, Aviano, Italy
Investigators
Principal Investigator: Daniele Regge Institute Institute for Cancer Research and Treatment, Candiolo, Italy
  More Information

No publications provided by im3D S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniele Regge, Institute of Cancer Research and Treatment, Candiolo - Italy
ClinicalTrials.gov Identifier: NCT01399710     History of Changes
Other Study ID Numbers: CAD COLON 001
Study First Received: July 15, 2011
Last Updated: July 21, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by im3D S.p.A.:
colorectal cancer
CT colonography
CAD

ClinicalTrials.gov processed this record on August 28, 2014