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Article History

Received: 4 October 2022

Revised: 9 July 2023

Accepted: 30 July 2023

First Online: 2 October 2023

Declarations

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: The scientific guarantor of this publication is Zhaoxiang Ye.

: The authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.

: One of the authors (Marco Caballo) has significant statistical expertise.

: Data for this study was collected from two prospective clinical trials, named “Koning breast CT for breast imaging in China” and “The technical operations and standard clinical application protocol of cone-beam breast CT in diagnostic process of breast cancer”, in which written informed consent including permission to re-use the data for any further retrospective analysis was obtained from every patient at the time of enrollment.

: Institutional Review Board approval was obtained (E2012036, bc2016039, and A2011-030-01).

: The study subjects were collected from two prospective clinical trials (NCT01792999 and NCT03861221), aiming to assess the performance of new-generation breast imaging modality—CBBCT and explore the clinical application guideline of CBBCT, respectively. There have been several publications that share the same cohort with the current study regarding breast coverage and patient comfort comparison, diagnostic performance analysis, visual and quantitative breast density assessment, molecular subtyping, tumor size evaluation, and BI-RADS atlas exploration. In contrast, here we investigated axillary lymph node status and metastatic burden prediction that has not been evaluated previously.• Li H, Yin L, Ye Z et al (2015) Comparative study of breast tissue coverage in cone-beam breast CT versus digital mammography. Chin J Radiol 49:488-490 in Chinese• He N, Wu YP, Kong Y et al (2016) The utility of breast cone-beam computed tomography, ultrasound, and digital mammography for detecting malignant breast tumors: a prospective study with 212 patients. Eur J Radiol 85:392-403• Yin L, Ye Z (2016) New 3D X-ray modalities in breast imaging: digital breast tomosynthesis and cone-beam breast computed tomography. Chin Med Device Inform 22:17-20 in Chinese• Liu A, Ye Z, Ma Y, Cao Y (2018) Reliability of breast density estimation based on cone-beam breast CT. Chin J Clin Oncol 45:246-250 in Chinese• Liu A, Ma Y, Yin L, Han P, Li H, Ye Z (2018) Comparison of the diagnostic efficiency in breast malignancy between cone-beam breast CT and mammography in dense breast. Chin J Oncol 40:604-609 in Chinese• Liu A, Ma Y, Yin L, Han P, Li H, Ye Z (2018) Diagnostic value of contrast-enhanced cone-beam breast CT in dense breast lesions. Chin Oncol 28:807-812 in Chinese• Ma Y, Ye Z, Liu A, Yin L, Han P, Li H (2019) The accuracy of tumor size evaluation on invasive breast cancer based on cone-beam breast CT. Chin J Radiol 53:286-291 in Chinese• Ma Y, Cao Y, Liu A et al (2019) A reliability comparison of cone-beam breast computed tomography and mammography: breast density assessment referring to the fifth edition of the BI-RADS atlas. Acad Radiol 26:752-759• Li H, Yin L, He N et al (2019) Comparison of comfort between cone-beam breast computed tomography and digital mammography. Eur J Radiol 120:108674• Zhu Y, Zhang Y, Ma Y et al (2020) Cone-beam breast CT features associated with HER2/neu overexpression in patients with primary breast cancer. Eur Radiol 30:2731-2739• Ma Y, Liu A, O’Connell AM et al (2021) Contrast-enhanced cone-beam breast CT features of breast cancers: correlation with immunohistochemical receptors and molecular subtypes. Eur Radiol 31:2580-2589• Wang Y, Ma Y, Zhu Y et al (2021) Value of cone-beam breast CT in differentiating benign from malignant dense breast masses. Chin J Radiol 55:961-967 in Chinese• Zhang Y, Ma Y, Li Y et al (2021) Comparative study of cone-beam breast CT and breast MRI in diagnosis of BI-RADS 4 lesions on mammography or ultrasound. J Clin Radiol 40:1703-1708 in Chinese• Zhu Y, O'Connell AM, Ma Y et al (2022) Dedicated breast CT: state of the art-part I. historical evolution and technical aspects. Eur Radiol 32:1579-1589• Zhu Y, O'Connell AM, Ma Y et al (2022) Dedicated breast CT: state of the art-part II. clinical application and future outlook. Eur Radiol 32:2286-2300• Liu A, Yin L, Ma Y et al (2022) Quantitative breast density measurement based on three-dimensional images: a study on cone-beam breast computed tomography. Acta Radiol 63:1023-1031• Ma Y, Liu A, Zhang Y et al (2022) Comparison of background parenchymal enhancement (BPE) on contrast-enhanced cone-beam breast CT (CE-CBBCT) and breast MRI. Eur Radiol 32:5773-5782• Liu A, Ma Y, Yin L et al (2023) Comparison of malignant calcification identification between breast cone-beam computed tomography and digital mammography. Acta Radiol 64:962-970• Wang Y, Zhao M, Ma Y et al (2023) Accuracy of preoperative contrast-enhanced cone-beam breast CT in assessment of residual tumor after neoadjuvant chemotherapy: a comparative study with breast MRI. Acad Radiol 30:1805-1815

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