Ocasio-Villa Fernando, Morales-Torres Luisa, Velez-Medina Norma, Cubano Luis A, Orengo Juan C, Suarez Martinez Edu B
CEM: Corporación Especial Municipal para el Desarrollo de Investigaciones en Ciencias y Tecnologia de Ponce, Ponce, Puerto Rico.
Public Health Program, Ponce Health Sciences University, Ponce, Puerto Rico.
Front Med (Lausanne). 2022 Feb 10;8:805182. doi: 10.3389/fmed.2021.805182. eCollection 2021.
Breast cancer is the leading cause of sex-specific female cancer deaths in the United States. Detection at earlier stages contributes to decreasing the mortality rate. The mammogram is the "Gold Standard" for breast cancer screening with an estimated sensitivity of 86.9% and a specificity of 88.9%. However, these values are negatively affected by the breast density considered a risk factor for developing breast cancer. Herein, we validate the novel LED-based medical device Pink Luminous Breast (PLB) by comparison with the mammogram using a double blinded approach. The PLB works by emitting a LED red light with a harmless spectrum of 640-800 nanometers. This allows the observation of abnormalities represented by dark or shadow areas. In this study, we evaluated the sensitivity and specificity of the PLB device as a screening tool for the early detection of breast abnormalities. Our results show that the PLB device has a high sensitivity (89.6%) and specificity (96.4%) for detecting breast abnormalities comparable to the adjusted mammogram values: 86.3 and 68.9%, respectively. The percentage of presence of breast density was 78.2% using PLB vs. 72.9% with the mammogram. Even with higher findings of breast density, the PLB is still capable of detecting 9.4% of calcifications compared to 6.2% in mammogram results and the reported findings for cysts, masses, or tumor-like abnormalities was higher using the PLB (6.5%) than the mammogram (5.6%). A 100% of the participants felt comfortable using the device without feeling pain or discomfort during the examination with 100% acceptability. The PLB positive validation shows its potential for routine breast screening at non-clinical settings. The PLB provides a rapid, non-invasive, portable, and easy-to-use tool for breast screening that can complement the home-based breast self-examination technique or the clinical breast examination. In addition, the PLB can be conveniently used for screening breasts with surgical implants. PLB provides an accessible and painless breast cancer screening tool. The PLB use is not intended to replace the mammogram for breast screening but rather to use it as an adjunct or complemental tool as part of more efficient earlier detection strategies contributing to decrease mortality rates.
乳腺癌是美国女性特定性别癌症死亡的主要原因。早期检测有助于降低死亡率。乳房X光检查是乳腺癌筛查的“金标准”，估计敏感度为86.9%，特异度为88.9%。然而，这些数值会受到乳房密度的负面影响，乳房密度被认为是患乳腺癌的一个风险因素。在此，我们采用双盲法将基于新型发光二极管（LED）的医疗设备粉红发光乳腺仪（PLB）与乳房X光检查进行比较，以验证其有效性。PLB通过发出波长为640 - 800纳米的无害光谱的LED红光来工作。这使得能够观察到由暗区或阴影区域所代表的异常情况。在本研究中，我们评估了PLB设备作为早期检测乳房异常的筛查工具的敏感度和特异度。我们的结果表明，PLB设备检测乳房异常的敏感度（89.6%）和特异度（96.4%）较高，与调整后的乳房X光检查值相当，分别为86.3%和68.9%。使用PLB时乳房密度出现的百分比为78.2%，而使用乳房X光检查时为72.9%。即使乳房密度的检出率更高，PLB仍能够检测出9.4%的钙化，而乳房X光检查结果为6.2%，并且使用PLB检测囊肿、肿块或肿瘤样异常的报告结果（6.5%）高于乳房X光检查（5.6%）。100%的参与者在使用该设备时感觉舒适，检查过程中没有感到疼痛或不适，接受度为100%。PLB的阳性验证表明其在非临床环境中进行常规乳房筛查的潜力。PLB提供了一种快速、无创、便携且易于使用的乳房筛查工具，可补充家庭乳房自我检查技术或临床乳房检查。此外，PLB可方便地用于筛查有手术植入物的乳房。PLB提供了一种可及且无痛的乳腺癌筛查工具。PLB的使用并非旨在取代乳房X光检查进行乳房筛查，而是将其作为更有效的早期检测策略的一部分，作为辅助或补充工具，以降低死亡率。
