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目的应用功能性3D红外成像系统(3DIRI)联合多参数计算机分析对乳腺癌进行风险评估。基于临床已知实验数据的自动参数,该技术可提供恶性肿瘤的客观风险评估。方法经机构审查委员会批准,共收集434名妇女用于此项前瞻性多中心试验,其中包括256名常规筛查乳腺X线摄影结果为BI-RADS-1的健康妇女和178例最近被诊断为乳腺癌的妇女。研究分为两期:最初的培训和校准阶段,随后是双盲评估阶段(52例健康的和66例乳腺癌妇女)。应用非接触式、无放射系统获取3DIRI数据集。结果功能性红外成像对乳腺癌进行正确风险评估的敏感度与特异度分别为90.0%和72.5%。ROC曲线下面积为86%。系统正确分类为可疑的病人中,60个病灶中的42个(70%)直径<20mm。结论这种新技术的最初双盲结果显示,功能性红外成像对乳腺癌的风险评估足以保证进一步的临床研究。要点①3DIRI可提供乳腺病变新的代谢特征。②3DIRI对乳腺癌的风险评估具有高度敏感性。③它也具有适中的特异性。④初步经验可保证进一步大宗临床试验研究。
Objective To evaluate the risk of breast cancer using functional 3D infrared imaging system (3DIRI) combined with multi-parameter computer analysis. Based on the automated parameters of clinically known experimental data, this technique provides an objective risk assessment of malignancy. Methods Approved by the Institutional Review Board, a total of 434 women were enrolled in this prospective, multicenter trial including 256 healthy women with routine screening for mammography BI-RADS-1 and 178 recently diagnosed Women with breast cancer. The study was divided into two phases: the initial training and calibration phase, followed by a double-blind evaluation phase (52 healthy and 66 breast cancer women). Get 3DIRI datasets using a non-contact, non-radiological system. Results The sensitivity and specificity of functional infrared imaging for the correct risk assessment of breast cancer were 90.0% and 72.5%, respectively. The area under the ROC curve was 86%. Of the 60 patients correctly classified as suspicious, 42 (70%) of the 60 lesions had a diameter of <20 mm. Conclusions The initial double-blind results of this new technique show that the assessment of risk for functional breast cancer by functional infrared imaging is sufficient to warrant further clinical studies. Points ① 3DIRI can provide new metabolic features of breast lesions. 3DIRI breast cancer risk assessment is highly sensitive. ③ It also has moderate specificity. ④ Preliminary experience can guarantee further bulk clinical trial research.