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一种多阅读者多病例(MRMC)的接收器操作特性(ROC)研究,评估定量传输(QT)超声对数字乳腺断层合成术(DBT)在乳腺病变检测和召回中的非劣效性。

A Multireader Multicase (MRMC) Receiver Operating Characteristic (ROC) Study Evaluating Noninferiority of Quantitative Transmission (QT) Ultrasound to Digital Breast Tomosynthesis (DBT) on Detection and Recall of Breast Lesions.

机构信息

Department of Radiology, the University of Chicago, 5841 South Maryland Ave, MC2026, Chicago, IL 60637.

QT Imaging Inc, Novato, California.

出版信息

Acad Radiol. 2024 Jun;31(6):2248-2258. doi: 10.1016/j.acra.2023.12.038. Epub 2024 Jan 29.

DOI:10.1016/j.acra.2023.12.038
PMID:38290888
Abstract

RATIONALE AND OBJECTIVES

Quantitative transmission (QT) imaging is an emerging volumetric ultrasound modality for women too young for mammography. QT images tissue without overlap seen in mammography, thereby can potentially improve breast mass detection and characterization and noncancer recall. We compared radiologists' interpretation of QT vs digital breast tomosynthesis (DBT) with a multireader multicase observer performance study.

MATERIALS AND METHODS

Study subjects received screening DBT and QT scans in HIPAA-compliant, institutional review board-approved prospective case-collection studies at four clinical sites. Twenty-four Mammography Quality Standards Act-qualified radiologists interpreted 177 cases (66 with cancer, atypia, or solid mass and 111 normal or with nonsolid benign abnormality), first QT, then 2 weeks later DBT synthesized 2D-views. Readers reported up to three findings per case and for each finding a recall or no recall decision and confidence of that decision. The study hypothesis was area under receiver operating characteristic curve (AUC) of QT was noninferior to DBT. Sensitivity and specificity were also compared.

RESULTS

AUC of QT (0.746 ± 0.028, mean ± SD) was noninferior to DBT (0.700 ± 0.028) for AUC difference margin of -0.05 (P < .05). AUC difference was 0.046 ± 0.028 (95% CI: [-0.008, 0.101]). Sensitivity was 70.6 ± 7.2% for QT and 85.2 ± 6.4% for DBT, specificity was 60.1 ± 12.3% vs 37.2 ± 11.0%, and both differences were statistically significant. Of a total of 21 cases of cysts, readers recommended recall, on average, in 1.1 ± 1.4 cases with QT, but not with DBT, and 10.6 ± 2.2 cases with DBT, but not with QT.

CONCLUSION

QT can be a potential alternative to mammography for breast cancer screening of women too young to undergo mammography.

摘要

原理和目的

定量传输(QT)成像技术是一种新兴的超声容积成像方式,适用于年龄太小而无法进行乳房 X 光检查的女性。QT 图像无重叠,可显示乳房 X 光摄影术所见的组织,从而有可能提高乳房肿块的检测和特征描述,减少非癌症召回。我们通过多读者多病例观察者性能研究比较了 QT 与数字乳腺断层合成术(DBT)的放射科医生解释。

材料和方法

在 HIPAA 合规性、机构审查委员会批准的前瞻性病例收集研究中,研究对象接受了筛查 DBT 和 QT 扫描,在四个临床站点进行。24 名符合 Mammography Quality Standards Act 标准的放射科医生解释了 177 例病例(66 例有癌症、非典型或实性肿块,111 例正常或有非实性良性异常),首先是 QT,然后在 2 周后合成 2D 视图。每位读者对每个病例最多报告三个发现,并对每个发现做出召回或不召回的决定,并对该决定的置信度进行报告。研究假设是 QT 的接收者操作特征曲线(AUC)下面积(AUC)不低于 DBT。还比较了灵敏度和特异性。

结果

QT 的 AUC(0.746±0.028,平均值±标准差)不低于 DBT 的 AUC(0.700±0.028),AUC 差值的边界为-0.05(P<0.05)。AUC 差值为 0.046±0.028(95%CI:[-0.008,0.101])。QT 的灵敏度为 70.6±7.2%,DBT 的灵敏度为 85.2±6.4%,特异性为 60.1±12.3%比 37.2±11.0%,差异均有统计学意义。在总共 21 例囊肿中,读者平均推荐在 1.1±1.4 例 QT 病例中召回,而不是 DBT,在 10.6±2.2 例 DBT 病例中召回,而不是 QT。

结论

QT 可为年龄太小而无法进行乳房 X 光检查的女性进行乳腺癌筛查提供一种替代乳房 X 光检查的潜在方法。

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