Xu Xin, Chung Youngsoo, Brooks Ari D, Shih Wei-Heng, Shih Wan Y
School of Biomedical Engineering, Science and Health Systems, Drexel University, Philadelphia, Pennsylvania 19104, USA.
Department of Surgery, College of Medicine, Drexel University, Philadelphia, Pennsylvania 19104, USA.
Rev Sci Instrum. 2016 Dec;87(12):124301. doi: 10.1063/1.4971325.
We have investigated the development of a handheld 4 × 1 piezoelectric finger (PEF) array breast tumor detector system towards in vivo patient testing, particularly, on how the duration of the DC applied voltage, the depression depth of the handheld unit, and breast density affect the PEF detection sensitivity on 40 patients. The tests were blinded and carried out in four phases: with DC voltage durations 5, 3, 2, to 0.8 s corresponding to scanning a quadrant, a half, a whole breast, and both breasts within 30 min, respectively. The results showed that PEF detection sensitivity was unaffected by shortening the applied voltage duration from 5 to 0.8 s nor was it affected by increasing the depression depth from 2 to 6 mm. Over the 40 patients, PEF detected 46 of the 48 lesions (46/48)-with the smallest lesion detected being 5 mm in size. Of 28 patients (some have more than one lesion) with mammography records, PEF detected 31/33 of all lesions (94%) and 14/15 of malignant lesions (93%), while mammography detected 30/33 of all lesions (91%) and 12/15 of malignant lesions (80%), indicating that PEF could detect malignant lesions not detectable by mammography without significantly increasing false positives. PEF's detection sensitivity is also shown to be independent of breast density, suggesting that PEF could be a potential tool for detecting breast cancer in young women and women with dense breasts.
我们已经对一种手持式4×1压电手指(PEF)阵列乳腺肿瘤检测系统的开发进行了研究,旨在进行体内患者测试,特别是研究施加直流电压的持续时间、手持式装置的下压深度以及乳腺密度如何影响对40名患者的PEF检测灵敏度。测试是在盲态下分四个阶段进行的:直流电压持续时间分别为5、3、2和0.8秒,对应于在30分钟内扫描一个象限、半个乳房、整个乳房以及双侧乳房。结果表明,将施加电压持续时间从5秒缩短至0.8秒,以及将下压深度从2毫米增加至6毫米,均未影响PEF检测灵敏度。在这40名患者中,PEF检测出了48个病变中的46个(46/48),检测到的最小病变大小为5毫米。在有乳腺钼靶检查记录的28名患者(有些患者有不止一个病变)中,PEF检测出了所有病变中的31/33个(94%)以及恶性病变中的14/15个(93%),而乳腺钼靶检查检测出了所有病变中的30/33个(91%)以及恶性病变中的12/15个(80%),这表明PEF能够检测出乳腺钼靶检查无法检测到的恶性病变,且不会显著增加假阳性率。PEF的检测灵敏度还显示出与乳腺密度无关,这表明PEF可能是检测年轻女性和乳腺致密女性乳腺癌的一种潜在工具。