Schulz-Wendtland R, Dilbat G, Bani M, Fasching P A, Heusinger K, Lux M P, Loehberg C R, Brehm B, Hammon M, Saake M, Dankerl P, Jud S M, Rauh C, Bayer C M, Beckmann M W, Uder M, Meier-Meitinger M
Gynäkologische Radiologie, Radiologisches Institut, Universitätsklinikum Erlangen, Erlangen.
Radiologische Praxis Roth und Weißenburg, Roth.
Geburtshilfe Frauenheilkd. 2013 May;73(5):422-427. doi: 10.1055/s-0032-1328600.
This prospective clinical study aimed to evaluate whether it would be possible to reduce the rate of re-excisions using CMOS technology, a specimen radiography system (SRS) or digital breast tomosynthesis (DBT) compared to a conventional full field digital mammography (FFDM) system. Between 12/2012 and 2/2013 50 patients were diagnosed with invasive breast cancer (BI-RADS™ 5). After histological verification, all patients underwent breast-conserving therapy with intraoperative imaging using 4 different systems and differing magnifications: 1. Inspiration™ (Siemens, Erlangen, Germany), amorphous selenium, tungsten source, focus 0.1 mm, resolution 85 µm pixel pitch, 8 lp/mm; 2. BioVision™ (Bioptics, Tucson, AZ, USA), CMOS technology, photodiode array, flat panel, tungsten source, focus 0.05, resolution 50 µm pixel pitch, 12 lp/mm; 3. the Trident™ specimen radiography system (SRS) (Hologic, Bedford, MA, USA), amorphous selenium, tungsten source, focus 0.05, resolution 70 µm pixel pitch, 7.1 lp/mm; 4. tomosynthesis (Siemens, Erlangen, Germany), amorphous selenium, tungsten source, focus 0.1 mm, resolution 85 µm pixel pitch, 8 lp/mm, angular range 50 degrees, 25 projections, scan time > 20 s, geometry: uniform scanning, reconstruction: filtered back projection. The 600 radiographs were prospectively shown to 3 radiologists. Of the 50 patients with histologically proven breast cancer (BI-RADS™ 6), 39 patients required no further surgical therapy (re-excision) after breast-conserving surgery. A retrospective analysis (n = 11) showed a significant (p < 0.05) increase of sensitivity with the BioVision™, the Trident™ and tomosynthesis compared to the Inspiration™ at a magnification of 1.0 : 2.0 or 1.0 : 1.0 (tomosynthesis) (2.6, 3.3 or 3.6 %), i.e. re-excision would not have been necessary in 2, 3 or 4 patients, respectively, compared to findings obtained with a standard magnification of 1.0 : 1.0. The sensitivity of the BioVision™, the Trident™ and tomosynthesis was significantly (p < 0.05) higher and the rate of re-excisions was reduced compared to FFDM using a conventional detector at a magnification of 2.0 but without zooming.
这项前瞻性临床研究旨在评估与传统的全视野数字乳腺摄影(FFDM)系统相比,使用互补金属氧化物半导体(CMOS)技术、标本射线照相系统(SRS)或数字乳腺断层合成(DBT)是否有可能降低再次切除率。在2012年12月至2013年2月期间,50例患者被诊断为浸润性乳腺癌(BI-RADS™ 5)。经组织学验证后,所有患者均接受保乳治疗,并在术中使用4种不同系统及不同放大倍数进行成像:1. Inspiration™(西门子,德国埃尔朗根),非晶硒,钨靶,焦点0.1毫米,分辨率85微米像素间距,8线对/毫米;2. BioVision™(Bioptics,美国亚利桑那州图森),CMOS技术,光电二极管阵列,平板,钨靶,焦点0.05,分辨率50微米像素间距,12线对/毫米;3. Trident™标本射线照相系统(SRS)(Hologic,美国马萨诸塞州贝德福德),非晶硒,钨靶,焦点0.05,分辨率70微米像素间距,7.1线对/毫米;4. 断层合成(西门子,德国埃尔朗根),非晶硒,钨靶,焦点0.1毫米,分辨率85微米像素间距,8线对/毫米,角度范围50度,25个投影,扫描时间>20秒,几何结构:均匀扫描,重建:滤波反投影。600张射线照片被前瞻性地展示给3位放射科医生。在50例经组织学证实为乳腺癌(BI-RADS™ 6)的患者中,39例患者在保乳手术后无需进一步手术治疗(再次切除)。一项回顾性分析(n = 11)显示,与Inspiration™相比,在放大倍数为1.0:2.0或1.0:1.0(断层合成)时,BioVision™、Trident™和断层合成的敏感度显著提高(p < 0.05)(分别为2.6%、3.3%或3.6%),即与标准放大倍数1.0:1.0的结果相比,分别有2、3或4例患者无需再次切除。与使用传统探测器、放大倍数为2.0但无变焦功能的FFDM相比,BioVision™、Trident™和断层合成的敏感度显著更高(p < 0.05),再次切除率降低。