Clinical trial NCT01399710: Impact of Computer-Aided Detection (CAD) as Second Reader in CT Colonography
Official title: Measure of Performances of CT Colonography With Computer-Aided Detection (CAD) as Second Reader in Detecting Colorectal Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Individuals With Suspected Colorectal Disease
Keywords: colorectal cancer
CT colonography
CAD
Lead sponsor: im3D S.p.A.
Sponsor class: OTHER
Collaborators: name: Candiolo Cancer Institute - IRCCS
name: Bicocca Universiy of Milano, Milan, Italy
name: Fondazione Salvatore Maugeri
name: Catholic University, Italy
name: Valduce Hospital
name: University of Turin, Italy
name: University of Roma La Sapienza
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Nuovo Regina Margherita Hospital
name: University of Pisa
name: University of Florence
name: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
First posted: 2011-07-22
Enrollment: 651
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm
measure: Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions
Secondary outcomes:
measure: Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger
measure: Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger
Other outcomes:
Locations:
Study officials:
affiliation: Institute Institute for Cancer Research and Treatment, Candiolo, Italy
name: Daniele Regge
role: PRINCIPAL_INVESTIGATOR
References:
citation: Regge D, Della Monica P, Galatola G, Laudi C, Zambon A, Correale L, Asnaghi R, Barbaro B, Borghi C, Campanella D, Cassinis MC, Ferrari R, Ferraris A, Hassan C, Golfieri R, Iafrate F, Iussich G, Laghi A, Massara R, Neri E, Sali L, Venturini S, Gandini G. Efficacy of computer-aided detection as a second reader for 6-9-mm lesions at CT colonography: multicenter prospective trial. Radiology. 2013 Jan;266(1):168-76. doi: 10.1148/radiol.12120376. Epub 2012 Nov 14.