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Diagnostic performance of automated breast ultrasound and handheld ultrasound in women with dense breasts

  • Clinical trial
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Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

Purpose

As an adjunct to mammography, ultrasound can improve the detection of breast cancer in women with dense breasts. We aimed to evaluate the diagnostic performance of automated breast ultrasound system (ABUS) and handheld ultrasound (HHUS) in Chinese women with dense breasts, both in combination with mammography and separately.

Methods

This is a cross-sectional multicenter clinical research study. Nine hundred and thirty-seven women with dense breasts underwent ABUS, HHUS, and mammography at one of five tertiary-care hospitals. The diagnostic performance of ABUS and HHUS was evaluated in combination with mammography, or separately in women with mammography-negative dense breasts. The agreement between ABUS and HHUS in breast cancer detection was also assessed.

Results

The sensitivity of the combination of ABUS or HHUS with mammography was 99.1% (219/221), and the specificities were 86.9% (622/716) and 84.9% (608/716), respectively. The area under the curve was 0.93 for ABUS combined with mammography and 0.92 for that of HHUS combined with mammography. Statistically significant agreement between ABUS and HHUS in breast cancer detection was observed (percent agreement = 0.94, κ = 0.85). The incremental cancer detection rate in mammography-negative dense breasts was 42.8 per 1000 ultrasound examinations.

Conclusions

Both ABUS and HHUS as adjuncts to mammography can significantly improve the breast cancer detection rate in women with dense breasts, and there is a strong correlation between them. Given the high prevalence of dense breasts and the multiple advantages of ABUS over HHUS, such as less operator dependence and reproducibility, ABUS showed great potential for use in breast cancer early detection, especially in resource-limited areas.

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Data availability

The datasets during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

ABUS:

Automated breast ultrasound system

AUC ROC:

The area under the receiver operating characteristic curve

BI-RADS:

Breast Imaging Reporting and Data System

CIs:

Confidence intervals

DCIS:

Ductal carcinoma in situ

FPR:

False-positive rate

HHUS:

Handheld ultrasound

MG:

Mammography

MRI:

Magnetic resonance imaging

NPV:

Negative predictive value

PPV:

Positive predictive value

SD:

Standard deviation

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Funding

This study was funded by GE Healthcare (No. CH-EPI-027) and Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (CIFMS 2017-I2M-B&R-03).

Author information

Authors and Affiliations

  1. National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China

    Mengmeng Jia, Xiang Zhou, Huijiao Yan & Youlin Qiao

  2. State Key Laboratory of Oncology in Southern China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, China

    Xi Lin & Anhua Li

  3. Xin Hua Hospital, Affiliated To Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China

    Yaqing Chen

  4. Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, 300060, China

    Peifang Liu

  5. The First People’s Hospital of Hangzhou, Affiliated Hangzhou Hospital of Nanjing Medical University, Hangzhou, 310006, China

    Lingyun Bao

  6. Screening Group, Early Detection and Prevention Section, International Agency for Research On Cancer, WHO, 150 Cours Albert ThomasCedex 08, 69372, Lyon, France

    Partha Basu

  7. Research Triangle Institute, International-India, Commercial Tower, Pullman Hotel Aerocity, New Delhi, 100037, India

    Rengaswamy Sankaranarayanan

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  1. Mengmeng Jia
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  2. Xi Lin
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Contributions

All co-authors contributed significantly to this study: Material preparation and data collection were performed by MJ, XL, XZ, HY, YC, PL, LB, and AL. Data analysis was performed by MJ. The first draft of the manuscript was written by MJ and XL. PB, YQ, and RS aided in the interpretation of the results and provided critical revisions. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Youlin Qiao.

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Conflict of interest

Author Mengmeng Jia is the 2018 GE Healthcare Call for proposal Awardee. Other authors declare that they have no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional Review Board of Cancer Hospital, Chinese Academy of Medical Sciences, all participant hospitals, and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Written informed consent was obtained from all participants included in this study.

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Jia, M., Lin, X., Zhou, X. et al. Diagnostic performance of automated breast ultrasound and handheld ultrasound in women with dense breasts. Breast Cancer Res Treat 181, 589–597 (2020). https://doi.org/10.1007/s10549-020-05625-2

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