Evaluation of the diagnostic value of a computed radiography system by comparison of digital hard copy images with screen-film mammography: results of a prospective clinical trial.

The purpose of the study was to determine prospectively the diagnostic value of a computed radiography (CR) system by comparing mammographic hard copy images with screen-film mammography (SFM). A series of 100 patients, who came for diagnostic investigation, underwent two-view SFM (Lorad M-IV Platinum) and digital mammography with a CR system (AGFA CR system). The images were obtained by double exposure, i.e. same view without removing compression of the corresponding breast. The CR images were processed with dedicated processing for mammography. Six radiologists read sets of SFM and CR images. The primary efficacy parameter was the overall diagnostic value. The secondary efficacy parameters were lesion conspicuity and lesion details (for masses and micro-calcifications), tissue visibility at chest wall and at skin line, axillary details, overall density and sharpness impression and the overall noise impression. These parameters were scored by a 7-point scoring system. "CR non-inferior to SFM" was concluded if the lower confidence interval bound exceeded 80%. The confidence interval for the overall diagnostic value was between 96.4% and 100%. Pooled analysis of the ten features for image quality comparison demonstrated for all but one feature (lesion details of the calcifications) CR non-inferiority to SFM.