Van Ongeval C, Bosmans H, Van Steen A, Joossens K, Celis V, Van Goethem M, Verslegers I, Nijs K, Rogge F, Marchal G
Department of Radiology, UZ Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium.
Eur Radiol. 2006 Jun;16(6):1360-6. doi: 10.1007/s00330-005-0134-9. Epub 2006 Mar 2.
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.
本研究的目的是通过比较乳腺钼靶硬拷贝图像与屏-片乳腺摄影（SFM），前瞻性地确定计算机X线摄影（CR）系统的诊断价值。100例前来进行诊断检查的患者接受了双视角SFM（Lorad M-IV Platinum）和使用CR系统（AGFA CR系统）的数字化乳腺摄影。图像通过双重曝光获得，即不解除对相应乳房的压迫进行相同视角的拍摄。CR图像采用专门的乳腺摄影处理方法进行处理。六位放射科医生阅读了SFM和CR图像组。主要疗效参数是总体诊断价值。次要疗效参数包括病变的可见度和病变细节（针对肿块和微钙化）、胸壁和皮肤线处的组织可见度、腋窝细节、总体密度和锐度印象以及总体噪声印象。这些参数采用7分评分系统进行评分。如果下限置信区间超过80%，则得出“CR不劣于SFM”的结论。总体诊断价值的置信区间在96.4%至100%之间。对用于图像质量比较的十个特征进行汇总分析表明，除了一个特征（钙化的病变细节）外，CR在所有特征上均不劣于SFM。
