Jagiellonian University, Krakow, Poland.
University Hospital in Krakow, Poland.
Integr Cancer Ther. 2020 Jan-Dec;19:1534735420915778. doi: 10.1177/1534735420915778.
Breast cancer is the most common cancer in women. While mammography is the standard for early detection in women older than 50 years of age, there is no standard for younger women. The aim of this prospective pilot study was to assess liquid crystal contact thermography, using the Braster device, as a means for the early detection of breast cancer. The device is intended to be used as a complementary tool to standard of care (sonography, mammography, etc). A total of 274 consecutive women presenting at Polish breast centers for prophylactic breast examination were enrolled to receive thermography; 19 were excluded for errors in thermographic image acquisition. The women were divided according to age (n = 135, <50 years; n = 120, ≥50 years). A control population was included (n = 40, <50 years; n = 23, ≥50 years). The primary endpoint, stratified by age group, was the -statistic for discrimination between breast cancer and noncancer. In women with abnormal breast ultrasound (n = 95, <50 years; n = 87, ≥50 years), the -statistic was 0.85 and 0.75, respectively ( = .20), for discrimination between breast cancer and noncancer. Sensitivity did not differ ( = .79) between the younger (82%) and older women (78%), while specificity was lower in the older women (60% vs 87%, = .025). The false-positive rate was similar in women with normal and abnormal breast ultrasound. Positive thermographic result in women with Breast Imaging Reporting and Data System (BIRADS) 4A on ultrasound increased the probability of breast cancer by over 2-fold. Conversely, a negative thermographic result decreased the probability of cancer more than 3-fold. Breast size and structure did not affect the thermography performance. No adverse events were observed. Thermography performed well in women <50 years of age, while its specificity in women ≥50 years was inadequate. These promising findings suggest that the Braster device deserves further investigation as a supporting tool for the early detection of breast cancer in women younger than 50 years of age.
乳腺癌是女性最常见的癌症。虽然乳腺 X 线摄影是 50 岁以上女性早期检测的标准，但对于年轻女性则没有标准。本前瞻性试点研究的目的是评估使用 Braster 设备的液晶接触热成像作为早期发现乳腺癌的一种手段。该设备旨在作为标准护理（超声、乳腺 X 线摄影等）的补充工具。共有 274 名连续出现于波兰乳腺中心进行预防性乳腺检查的女性被纳入接受热成像检查；由于热成像图像采集错误，有 19 名被排除在外。这些女性根据年龄分为两组（n = 135，<50 岁；n = 120，≥50 岁）。还纳入了对照组（n = 40，<50 岁；n = 23，≥50 岁）。按年龄组分层的主要终点是区分乳腺癌和非癌的卡方统计量。在有异常乳腺超声的女性中（n = 95，<50 岁；n = 87，≥50 岁），乳腺癌和非癌之间的卡方统计量分别为 0.85 和 0.75（ =.20）。年轻女性（82%）和老年女性（78%）之间的敏感性无差异（ =.79），而老年女性的特异性较低（60%对 87%， =.025）。在乳腺超声正常和异常的女性中，假阳性率相似。在乳腺超声 BI-RADS 4A 的女性中，阳性热成像结果使乳腺癌的可能性增加了两倍以上。相反，阴性热成像结果使癌症的可能性降低了三倍以上。乳房大小和结构不影响热成像性能。未观察到不良事件。热成像在 50 岁以下女性中表现良好，而在 50 岁以上女性中的特异性不足。这些有希望的发现表明，Braster 设备值得进一步研究，作为 50 岁以下女性早期发现乳腺癌的辅助工具。
