A Pivotal Study of Optoacoustic Imaging to Diagnose Benign and Malignant Breast Masses: A New Evaluation Tool for Radiologists
A Pivotal Study of Optoacoustic Imaging to Diagnose Benign and Malignant Breast Masses: A New Evaluation Tool for Radiologists
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DOI：
10.1148/radiol.2017172228
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发表时间：
2018-05-01
期刊：
影响因子：
19.7
通讯作者：
Dogan, Basak E.
中科院分区：
文献类型：
--
作者：
Neuschler, Erin I.;Butler, Reni;Dogan, Basak E.
目的：比较一种研究性光声成像设备（融合激光光学成像（OA）和灰阶超声（US））与单独灰阶超声在区分良性和恶性乳腺肿块方面的诊断效用。材料和方法：这项前瞻性研究，16个地点，2105名妇女（研究周期：2012年12月21日至2015年9月9日）比较了由7名设盲独立阅片人分配的乳腺成像报告和数据系统（BI-RADS）分类，使用OA/US与仅使用US进行良性和恶性乳腺肿块。诊断性超声评估的BI-RADS 3、4或5个肿块，活检证实的组织学结果，以及12个月时BI-RADS 3个肿块稳定，符合条件。独立阅片人审查了使用OA/US器械获得的US图像，分配了恶性肿瘤概率（POM）和BI-RADS类别，并锁定了结果。然后，相同的独立阅片人审查OA/US图像，对OA特征进行评分，并分配OA/US POM和BI-RADS类别。计算US和OA/US的特异性和灵敏度。良性和恶性肿块的升级和降级率，阳性和阴性预测值，阳性和阴性似然比进行了compared.Results：2105同意受试者2191群众，100名受试者（103群众）分别作为一个培训人口进行了分析，并排除。另外202例受试者（210个肿块）因技术故障或成像不完整而被排除，72例受试者（78个肿块）因方案偏离而被排除，41例受试者（43个肿块）因高风险组织学结果而被排除。1690例受试者，1757例肿块（1079例[61.4%]良性和678例[38.6%]恶性肿块），OA/US降级40.8%（3078/7535），特异性为43.0%（3242/7538，99%置信区间[CI]：40.4%，45.7%），而OA/US器械的内部US为28.1%（2120/7543，99% CI：25.8%，30.5%）。OA/US特异性高于US 14.9%（P
Purpose: To compare the diagnostic utility of an investigational optoacoustic imaging device that fuses laser optical imaging (OA) with grayscale ultrasonography (US) to grayscale US alone in differentiating benign and malignant breast masses.Materials and Methods: This prospective, 16-site study of 2105 women (study period: 12/21/2012 to 9/9/2015) compared Breast Imaging Reporting and Data System (BI-RADS) categories assigned by seven blinded independent readers to benign and malignant breast masses using OA/US versus US alone. BI-RADS 3, 4, or 5 masses assessed at diagnostic US with biopsy-proven histologic findings and BI-RADS 3 masses stable at 12 months were eligible. Independent readers reviewed US images obtained with the OA/US device, assigned a probability of malignancy (POM) and BI-RADS category, and locked results. The same independent readers then reviewed OA/US images, scored OA features, and assigned OA/US POM and a BI-RADS category. Specificity and sensitivity were calculated for US and OA/US. Benign and malignant mass upgrade and downgrade rates, positive and negative predictive values, and positive and negative likelihood ratios were compared.Results: Of 2105 consented subjects with 2191 masses, 100 subjects (103 masses) were analyzed separately as a training population and excluded. An additional 202 subjects (210 masses) were excluded due to technical failures or incomplete imaging, 72 subjects (78 masses) due to protocol deviations, and 41 subjects (43 masses) due to high-risk histologic results. Of 1690 subjects with 1757 masses (1079 [61.4%] benign and 678 [38.6%] malignant masses), OA/US downgraded 40.8% (3078/7535) of benign mass reads, with a specificity of 43.0% (3242/7538, 99% confidence interval [CI]: 40.4%, 45.7%) for OA/US versus 28.1% (2120/7543, 99% CI: 25.8%, 30.5%) for the internal US of the OA/US device. OA/US exceeded US in specificity by 14.9% (P