Comparing CT colonography and flexible sigmoidoscopy: a randomised trial within a population-based screening programme.

IMPORTANCE AND AIMS: The role of CT colonography (CTC) as a colorectal cancer (CRC) screening test is uncertain. The aim of our trial was to compare participation and detection rate (DR) with sigmoidoscopy (flexible sigmoidoscopy (FS)) and CTC in a screening setting. DESIGN SETTING AND PARTICIPANTS: We conducted two randomised clinical trials (RCTs). (1) Participation RCT: individuals, aged 58 years, living in Turin (Italy), were randomly assigned to be invited to FS or CTC screening; (2) detection RCT: residents in northern Italy, aged 58-60, giving their consent to recruitment, were randomly allocated to CTC or FS. Polyps ≥6 mm at CTC, or 'high-risk' distal lesions at FS, were referred for colonoscopy (TC). MAIN OUTCOME MEASURES: Participation rate (proportion of invitees examined); DR of advanced adenomas or CRC (advanced neoplasia (AN)). RESULTS: Participation was 30.4% (298/980) for CTC and 27.4% (267/976) for FS (relative risk (RR) 1.1; 95% CI 0.98 to 1.29). Among men, participation was higher with CTC than with FS (34.1% vs 26.5%, p=0.011). In the detection RCT, 2673 subjects had FS and 2595 had CTC: the AN DR was 4.8% (127/2673, including 9 CRCs) with FS and 5.1% (133/2595, including 10 CRCs) with CTC (RR 1.08; 95% CI 0.85 to 1.37). Distal AN DR was 3.9% (109/2673) with FS and 2.9% (76/2595) with CTC (RR 0.72; 95% CI 0.54 to 0.96); proximal AN DR was 1.2% (34/2595) for FS vs 2.7% (69/2595) for CTC (RR 2.06; 95% CI 1.37 to 3.10). CONCLUSIONS AND RELEVANCE: Participation and DR for FS and CTC were comparable. AN DR was twice as high in the proximal colon and lower in the distal colon with CTC than with FS. Men were more likely to participate in CTC screening. TRIAL REGISTRATION NUMBER: NCT01739608; Pre-results.

Diagnostic accuracy of commercial system for computer-assisted detection (CADx) as an adjunct to interpretation of mammograms.

PURPOSE: To evaluate the diagnostic accuracy of the commercial computer-aided detection CADx system for the reading of mammograms. MATERIALS AND METHODS: The study assessed the Second Look system developed and marketed by CADx Medical Systems, Montreal, Canada. The diagnostic sensitivity was evaluated by means of a retrospective study on 98 consecutive cancers detected at screening by double independent reading. The specificity and the positive predictive value (PPV) for cancer of the CADx system were prospectively evaluated on a second group of 560 consecutive mammograms of asymptomatic women not included in screening program. The radiologist who was present during the test assessed the abnormal mammographic findings by one or more of the following diagnostic procedures: physical examination, additional mammographic detail views with or without magnification, ultrasonography, ultrasound- or mammography-guided fine needle aspiration cytology, and core-biopsy. The exams first underwent conventional reading and then a second reading carried out with the aid of the CADx system. RESULTS: The overall diagnostic sensitivity of the CADx system on the 98 screening cancers was 81.6%; in particular it was 89.3% for calcifications, 83.9% for masses and only 37.5% for architectural distortion. The CADx markings for each mammography were 4.7 on average. Identification of invasive carcinoma was independent from tumour size. In the second group of 560 mammograms, the CADx system marked all cases identified as positive by conventional reading and confirmed by biopsy (7/7), but did not permit the detection of any additional cancer. The CADx markings per exam were 4.2 on average, the specificity was 13.7% and the PPV was 0.55% versus 13.7% recall rate of conventional reading. CADx reading led to a 1.96% (11/560) increase of the women necessitating further diagnostic investigation. CONCLUSIONS: The results of our study show that the diagnostic sensitivity of the CADx system is lower than that obtained by double independent reading at screening. Used in association with conventional reading of mammograms of asymptomatic women the CADx system did not increase diagnostic sensitivity.