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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01399710
Acronym
CAD-IMPACT
Enrollment
651
Registered
2011-07-22
Start date
2007-07-31
Completion date
2010-03-31
Last updated
2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuals With Suspected Colorectal Disease

Keywords

colorectal cancer, CT colonography, CAD

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 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.

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.

Interventions

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.

PROCEDUREcolonoscopy

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

DEVICECT 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

Candiolo Cancer Institute - IRCCS
CollaboratorOTHER
Bicocca Universiy of Milano, Milan, Italy
CollaboratorUNKNOWN
Fondazione Salvatore Maugeri
CollaboratorOTHER
Catholic University, Italy
CollaboratorOTHER
Valduce Hospital
CollaboratorOTHER
University of Turin, Italy
CollaboratorOTHER
University of Roma La Sapienza
CollaboratorOTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
CollaboratorOTHER
Nuovo Regina Margherita Hospital
CollaboratorOTHER
University of Pisa
CollaboratorOTHER
University of Florence
CollaboratorOTHER
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
CollaboratorOTHER
im3D S.p.A.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm
Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions

Secondary

MeasureTime frame
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026