From the Department of Radiology, University of Washington, Seattle, Wash (M.B.L., S.C.P., H.R., D.L.L., C.I.L., K.P.L., I.L., D.B., M.L.B., J.M.L.); Department of Radiology (M.B.L., S.C.P., H.R., D.L.L., C.I.L., K.P.L., I.L., D.B., M.L.B., J.M.L.) and Clinical Research Division (D.S.H.), Fred Hutchinson Cancer Center, 825 Eastlake Eve E, LG-200, Seattle, WA 98109; Department of Radiology, Vanderbilt University, Nashville, Tenn (J.R.S.); and Department of Radiology, Kaiser Permanente, Seattle, Wash (S.P.).
Radiology. 2023 Aug;308(2):e230576. doi: 10.1148/radiol.230576.
Background Contrast-enhanced mammography (CEM) and abbreviated breast MRI (ABMRI) are emerging alternatives to standard MRI for supplemental breast cancer screening. Purpose To compare the diagnostic performance of CEM, ABMRI, and standard MRI. Materials and Methods This single-institution, prospective, blinded reader study included female participants referred for breast MRI from January 2018 to June 2021. CEM was performed within 14 days of standard MRI; ABMRI was produced from standard MRI images. Two readers independently interpreted each CEM and ABMRI after a washout period. Examination-level performance metrics calculated were recall rate, cancer detection, and false-positive biopsy recommendation rates per 1000 examinations and sensitivity, specificity, and positive predictive value of biopsy recommendation. Bootstrap and permutation tests were used to calculate 95% CIs and compare modalities. Results Evaluated were 492 paired CEM and ABMRI interpretations from 246 participants (median age, 51 years; IQR, 43-61 years). On 49 MRI scans with lesions recommended for biopsy, nine lesions showed malignant pathology. No differences in ABMRI and standard MRI performance were identified. Compared with standard MRI, CEM demonstrated significantly lower recall rate (14.0% vs 22.8%; difference, -8.7%; 95% CI: -14.0, -3.5), lower false-positive biopsy recommendation rate per 1000 examinations (65.0 vs 162.6; difference, -97.6; 95% CI: -146.3, -50.8), and higher specificity (87.8% vs 80.2%; difference, 7.6%; 95% CI: 2.3, 13.1). Compared with standard MRI, CEM had significantly lower cancer detection rate (22.4 vs 36.6; difference, -14.2; 95% CI: -28.5, -2.0) and sensitivity (61.1% vs 100%; difference, -38.9%; 95% CI: -66.7, -12.5). The performance differences between CEM and ABMRI were similar to those observed between CEM and standard MRI. Conclusion ABMRI had comparable performance to standard MRI and may support more efficient MRI screening. CEM had lower recall and higher specificity compared with standard MRI or ABMRI, offset by lower cancer detection rate and sensitivity compared with standard MRI. These trade-offs warrant further consideration of patient population characteristics before widespread screening with CEM. Clinical trial registration no. NCT03517813 © RSNA, 2023 See also the editorial by Chang in this issue.
背景 对比增强乳腺摄影(CEM)和简化乳腺 MRI(ABMRI)是标准 MRI 用于补充乳腺癌筛查的新兴替代方法。
目的 比较 CEM、ABMRI 和标准 MRI 的诊断性能。
材料与方法 这项单中心前瞻性盲法读者研究纳入了 2018 年 1 月至 2021 年 6 月因乳腺 MRI 检查而转诊的女性参与者。CEM 在标准 MRI 检查后 14 天内进行;ABMRI 由标准 MRI 图像生成。两名读者在洗脱期后分别独立解读每例 CEM 和 ABMRI。计算的检查水平性能指标包括每 1000 次检查的召回率、癌症检出率和假阳性活检推荐率,以及活检推荐的敏感性、特异性和阳性预测值。采用 bootstrap 和置换检验计算 95%CI 并比较模态。
结果 评估了 246 名参与者的 492 对 CEM 和 ABMRI 解读(中位年龄,51 岁;IQR:43-61 岁)。在 49 例有病变建议活检的 MRI 扫描中,9 例病变显示恶性病理。ABMRI 和标准 MRI 的性能没有差异。与标准 MRI 相比,CEM 显示出显著较低的召回率(14.0%比 22.8%;差异,-8.7%;95%CI:-14.0,-3.5)、较低的每 1000 次检查假阳性活检推荐率(65.0 比 162.6;差异,-97.6;95%CI:-146.3,-50.8)和较高的特异性(87.8%比 80.2%;差异,7.6%;95%CI:2.3,13.1)。与标准 MRI 相比,CEM 的癌症检出率(22.4%比 36.6%;差异,-14.2%;95%CI:-28.5,-2.0)和敏感性(61.1%比 100%;差异,-38.9%;95%CI:-66.7,-12.5)明显降低。CEM 与标准 MRI 之间的性能差异与 CEM 与 ABMRI 之间的差异相似。
结论 ABMRI 的性能与标准 MRI 相当,可能支持更有效的 MRI 筛查。与标准 MRI 或 ABMRI 相比,CEM 的召回率较低,特异性较高,但与标准 MRI 相比,癌症检出率和敏感性较低。在广泛使用 CEM 进行筛查之前,这些权衡需要进一步考虑患者人群特征。
临床试验注册号 NCT03517813 © RSNA,2023 请参阅本期 Chang 医生的社论。