Background: 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). Patients and Methods: 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 C-statistic for discrimination between breast cancer and noncancer. Results: In women with abnormal breast ultrasound (n = 95, <50 years; n = 87, ≥50 years), the C-statistic was 0.85 and 0.75, respectively (P = .20), for discrimination between breast cancer and noncancer. Sensitivity did not differ (P = .79) between the younger (82%) and older women (78%), while specificity was lower in the older women (60% vs 87%, P = .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. Conclusions: 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.

中文翻译：

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使用液晶热成像技术检测早期乳腺癌的前瞻性先导研究。

背景：乳腺癌是女性中最常见的癌症。乳腺摄影是50岁以上女性早期发现的标准，而年轻女性则没有标准。这项前瞻性研究的目的是使用Braster装置评估液晶接触热成像技术，作为早期发现乳腺癌的一种手段。该设备旨在用作护理标准（超声检查，乳腺摄影等）的补充工具。患者和方法：共有274名在波兰乳腺中心接受预防性乳腺检查的女性接受了热像仪检查。排除了19个热像图图像获取错误。根据年龄对妇女进行划分（n = 135，<50岁； n = 120，≥50岁）。纳入对照人群（n = 40，<50岁； n = 23，≥50年）。按年龄组分层的主要终点指标是区分乳腺癌和非癌症的C统计量。结果：在乳腺超声异常的女性（n = 95，<50岁； n = 87，≥50岁）中，C统计学分别为0.85和0.75（P = .20），以区分乳腺癌和非癌。年龄较小的女性（82％）和年龄较大的女性（78％）之间的敏感性没有差异（P = .79），而年龄较大的女性的特异性较低（60％比87％，P = .025）。乳房超声检查正常和异常的女性假阳性率相似。乳房成像报告和数据系统（BIRADS）4A超声检查妇女的体温记录阳性结果使乳腺癌的可能性增加了2倍以上。相反，负热成像结果将癌症的可能性降低了3倍以上。乳房的大小和结构不影响热成像性能。没有观察到不良事件。结论：热成像在50岁以下女性中表现良好，而其在50岁以上女性中的特异性不足。这些令人鼓舞的发现表明，对于50岁以下的女性早期发现乳腺癌的支持工具，Braster装置值得进一步研究。