在基于数字乳腺断层合成的实践中对乳腺致密女性进行自动乳腺超声筛查的前瞻性研究。

A Prospective Study of Automated Breast Ultrasound Screening of Women with Dense Breasts in a Digital Breast Tomosynthesis-based Practice.

作者信息

Chough Denise M, Berg Wendie A, Bandos Andriy I, Rathfon Grace Y, Hakim Christiane M, Lu Amy H, Gizienski Terri-Ann, Ganott Marie A, Gur David

机构信息

University of Pittsburgh School of Medicine, Magee-Womens Hospital of UPMC, Department of Radiology, Pittsburgh, PA.

University of Pittsburgh, Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA.

出版信息

J Breast Imaging. 2020 Mar 25;2(2):125-133. doi: 10.1093/jbi/wbaa006.

DOI:10.1093/jbi/wbaa006

PMID:38424893

Abstract

OBJECTIVE

To assess prospectively the interpretative performance of automated breast ultrasound (ABUS) as a supplemental screening after digital breast tomosynthesis (DBT) or as a standalone screening of women with dense breast tissue.

METHODS

Under an IRB-approved protocol (written consent required), women with dense breasts prospectively underwent concurrent baseline DBT and ABUS screening. Examinations were independently evaluated, in opposite order, by two of seven Mammography Quality Standards Act-qualified radiologists, with the primary radiologist arbitrating disagreements and making clinical management recommendations. We report results for 1111 screening examinations (598 first year and 513 second year) for which all diagnostic workups are complete. Imaging was also retrospectively reviewed for all cancers. Statistical assessments used a 0.05 significance level and accounted for correlation between participants' examinations.

RESULTS

Of 1111 women screened, primary radiologists initially "recalled" based on DBT alone (6.6%, 73/1111, CI: 5.2%-8.2%), of which 20 were biopsied, yielding 6/8 total cancers. Automated breast ultrasound increased recalls overall to 14.4% (160/1111, CI: 12.4%-16.6%), with 27 total biopsies, yielding 1 additional cancer. Double reading of DBT alone increased the recall rate to 10.7% (119/1111), with 21 biopsies, with no improvement in cancer detection. Double reading ABUS increased the recall rate to 15.2% (169/1111, CI: 13.2%-17.5%) of women, of whom 22 were biopsied, yielding the detection of 7 cancers, including one seen only on double reading ABUS. Inter-radiologist agreement was similar for recall recommendations from DBT (κ = 0.24, CI: 0.14-0.34) and ABUS (κ = 0.23, CI: 0.15-0.32). Integrated assessments from both readers resulted in a recall rate of 15.1% (168/1111, CI: 13.1%-17.4%).

CONCLUSION

Supplemental or standalone ABUS screening detected cancers not seen on DBT, but substantially increased noncancer recall rates.

摘要

目的

前瞻性评估自动乳腺超声（ABUS）作为数字乳腺断层合成（DBT）后补充筛查或作为致密乳腺组织女性独立筛查的解读性能。

方法

在一项经机构审查委员会批准的方案（需要书面同意）下，致密乳腺女性前瞻性地同时接受基线DBT和ABUS筛查。由七名符合《乳腺摄影质量标准法案》的放射科医生中的两名以相反顺序独立评估检查结果，由首席放射科医生仲裁分歧并提出临床管理建议。我们报告了1111例筛查检查（第一年598例，第二年513例）的结果，所有诊断性检查均已完成。还对所有癌症进行了回顾性影像学检查。统计评估使用0.05的显著性水平，并考虑了参与者检查之间的相关性。

结果

在1111名接受筛查的女性中，首席放射科医生最初仅基于DBT“召回”（6.6%，73/1111，CI：5.2%-8.2%），其中20例接受活检，共检出6/8例癌症。自动乳腺超声总体上使召回率提高到14.4%（160/1111，CI：12.4%-16.6%），共27例活检，又检出1例癌症。仅对DBT进行双人读片使召回率提高到10.7%（119/1111），21例活检，癌症检出率无改善。对ABUS进行双人读片使召回率提高到15.2%（169/1111，CI：13.2%-17.5%），其中22例接受活检，共检出7例癌症，包括1例仅在对ABUS进行双人读片时发现的癌症。放射科医生之间对于DBT（κ = 0.24，CI：0.14-0.34）和ABUS（κ = 0.23，CI：0.15-0.32）召回建议的一致性相似。两位读者的综合评估导致召回率为15.1%（168/1111，CI：13.1%-17.4%）。