功能生物学数据和成像外观的结合有可能增加诊断信息，帮助放射科医生以高效、有效和具有成本意识的方式评估乳腺肿块。这是对 Gen 2（型号 9100、8101）Imagio® 系统的首次临床评估，用于评估独立内部超声 (IUS)、纯超声换能器和光声/超声 (OA/US) 的图像质量双工探针 (1,2)。这项研究评估了被转诊进行诊断性乳房超声检查的患者的可触及和不可触及的乳房异常。本研究旨在确认 Imagio® Gen 1 版本上市前批准 (PMA) 后对 Imagio® 系统超声组件进行的修改的临床可接受性。这项前瞻性、单臂、非随机研究纳入了 38 名患有以下症状的患者：在单个研究部位检测到可触及的肿块和/或影像学异常。每位患者均使用 Gen 2 Imagio® 系统对乳房和腋窝淋巴结（如果有指示）进行成像。对于具有 SenoGram® 预测的恶性肿瘤可能性 (LOM) 和可用病理学的患者 (N = 23)，观察到的敏感性为 100.0% (9/9)，置信区间为 (66.4%, 100.0%)，使用 SenoGram® 预测的假阴性率 (FNR) 截止值 ≤ 2%。使用 SenoGram® 预测的 FNR 截止值 ≤ 2%，观察到的特异性为 64.3% (9/14)（置信区间：35.1%、87.2%）。在 98% 固定灵敏度下，OA/US SG 的特异性 (fSp) 为 100.0%，而 IUS 的特异性 (fSp) 为 0.0%。 fSp 的绝对增益为 100.0%。将结构与形态相结合可以提高特异性，而不会降低现实环境中的灵敏度。版权所有 © 2024 大学放射科医生协会。由爱思唯尔公司出版。保留所有权利。

The combination of functional biologic data and imaging appearance has the potential to add diagnostic information to help the radiologist evaluate breast masses in an efficient, effective, and cost-conscious manner. This is the first clinical evaluation of the Gen 2(Model 9100, 8101) Imagio® System to assess image quality with both the stand-alone internal ultrasound (IUS), ultrasound-only transducer, and the Optoacoustic/Ultrasound (OA/US) duplex probe (1,2). This study assesses palpable and non-palpable breast abnormalities in patients who are referred for diagnostic breast ultrasound work-up. This study is intended to confirm the clinical acceptability of modifications made to the Imagio® System ultrasound component following Premarket Approval (PMA) of the Imagio® Gen 1 version.This prospective, single-arm, non-randomized study included 38 patients presenting with a palpable lump and/or imaging abnormality detected at a single investigational site. Each patient had the breast, and if indicated, the axillary lymph nodes imaged with the Gen 2 Imagio® system.For patients with SenoGram®-predicted Likelihood of Malignancy (LOM) and pathology available (N = 23), observed sensitivity was 100.0% (9/9) with a confidence interval of (66.4%, 100.0%), using a SenoGram®-predicted False Negative Rate (FNR) cut-off of ≤ 2%. Observed specificity was 64.3% (9/14) (Confidence Interval: 35.1%, 87.2%), using a SenoGram®-predicted FNR cut-off of ≤ 2%. At 98% fixed sensitivity, the specificity (fSp) for OA/US + SG was 100.0% while it was 0.0% for IUS. The absolute gain in fSp was 100.0%.Combining structure with morphology can increase specificity without decreasing sensitivity in a real-world setting.Copyright © 2024 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.