From the Department of Radiology, Northeastern Ohio Medical University, Rootstown, Ohio (R.G.B.); Radiology Consultants Inc, 7623 Market St, Boardman, OH 44512 (R.G.B.); and Department of Biostatistics and Center for Statistical Sciences, Brown University, Providence, RI (Z.Z.).
Radiology. 2015 Apr;275(1):45-53. doi: 10.1148/radiol.14132404. Epub 2014 Nov 24.
To determine whether addition of quality measure (QM) of shear-wave (SW) velocity (Vs) estimation can increase SW elastography sensitivity for breast cancer.
With written informed consent, this institutional review board-approved, HIPAA-compliant study included 143 women (mean age, 48.5 years ± 8.7) scheduled for breast biopsy. Mean lesion size was 16.4 mm ± 11.8; 95 (66%) lesions were benign; 48 (34%), malignant. If more than one lesion was present, lesion with highest Breast Imaging Reporting and Data System (BI-RADS) category was chosen. If there were more than one with highest BI-RADS category, a lesion was randomly selected. Conventional ultrasonography (US), strain elastography, and SW elastography were performed with QM. QM assesses SW quality to provide accurate Vs. Lesions were evaluated for Vs and QM (high or low). Lesions with Vs of less than 4.5 m/sec were classified benign; lesions with Vs of 4.5 m/sec or greater, malignant. Results were correlated with pathologic findings. Vs data with or without incorporating QM were used to determine SW elastography diagnostic performance. Binomial proportions and exact 95% confidence intervals (CIs) were calculated.
In 95 benign lesions, 13 (14%) had no SW elastography signal; 77 (81%), Vs of less than 4.5 m/sec; and five (5%), Vs of 4.5 m/sec or greater. In 48 malignant lesions, eight (17%) had no SW elastography signal; 20 (42%), Vs of less than 4.5 m/sec; and 20 (42%), V of 4.5 m/sec or greater. QM was low in 17 of 20 (85%) malignant lesions with Vs of less than 4.5 m/sec. Without QM, using Vs of 4.5 m/sec or greater as test positive, SW elastography had lesion-level sensitivity of 50% (95% CI: 34%, 66%); specificity, 94% (95% CI: 86%, 98%); positive predictive value (PPV), 80% (95% CI: 59%, 93%); and negative predictive value (NPV), 79% (95% CI: 70%, 87%). Using QM where additional lesions with both low Vs and low QM were treated as test positive, SW elastography had lesion-level sensitivity of 93% (95% CI: 80%, 98%); specificity, 89% (95% CI: 80%, 95%); PPV, 80% (95% CI: 66%, 91%); and NPV, 96% (95% CI: 89%, 99%).
Addition of QM can improve SW elastography sensitivity, with no significant change in specificity.
确定在剪切波(SW)速度(Vs)估计的质量测量(QM)的基础上增加SW 弹性成像的灵敏度是否可以提高乳腺癌的诊断率。
本研究经机构审查委员会批准,符合 HIPAA 规定,入组了 143 名计划进行乳房活检的女性患者(平均年龄 48.5 岁±8.7 岁)。平均病灶大小为 16.4mm±11.8mm;95 个(66%)病灶为良性;48 个(34%)为恶性。如果存在多个病灶,则选择 BI-RADS 分类最高的病灶。如果有多个最高 BI-RADS 分类的病灶,则随机选择一个病灶。常规超声(US)、应变成像和 SW 弹性成像均进行了 QM 评估。QM 评估 SW 质量以提供准确的 Vs 值。评估病灶的 Vs 值和 QM(高或低)。Vs 值小于 4.5m/s 的病灶为良性;Vs 值为 4.5m/s 或更高的病灶为恶性。结果与病理发现相关。使用或不使用 QM 的 Vs 数据用于确定 SW 弹性成像的诊断性能。计算了二项式比例和 95%置信区间(CI)。
在 95 个良性病灶中,有 13 个(14%)没有 SW 弹性成像信号;77 个(81%)的 Vs 值小于 4.5m/s;5 个(5%)的 Vs 值为 4.5m/s 或更高。在 48 个恶性病灶中,有 8 个(17%)没有 SW 弹性成像信号;20 个(42%)的 Vs 值小于 4.5m/s;20 个(42%)的 Vs 值为 4.5m/s 或更高。在 20 个 Vs 值小于 4.5m/s 的恶性病灶中,有 17 个(85%)的 QM 较低。不使用 QM,将 Vs 值为 4.5m/s 或更高作为阳性测试,SW 弹性成像的病灶级敏感性为 50%(95%CI:34%,66%);特异性为 94%(95%CI:86%,98%);阳性预测值(PPV)为 80%(95%CI:59%,93%);阴性预测值(NPV)为 79%(95%CI:70%,87%)。如果将 QM 应用于具有低 Vs 和低 QM 的其他病灶,则将其视为阳性测试,SW 弹性成像的病灶级敏感性为 93%(95%CI:80%,98%);特异性为 89%(95%CI:80%,95%);PPV 为 80%(95%CI:66%,91%);NPV 为 96%(95%CI:89%,99%)。
添加 QM 可以提高 SW 弹性成像的灵敏度,而特异性没有显著变化。