Evaluation of breast lesions using a newly developed 3D breast ultrasound imaging device: a preliminary study on efficacy and validity

April 27, 2026Scientific ReportsOpen Access

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Key Points

This study aims to assess the image quality and diagnostic performance of a new 3D automated breast ultrasound system called MammouS-N.
Prospective evaluation involving 121 women with 139 breast lesions.
Image quality assessed across six parameters and lesion detectability compared with hand-held ultrasound.
Diagnostic performance analyzed using ROC analysis against pathology as the reference standard.
MammouS-N achieved acceptable image quality in over 90% of cases and visualized 94.2% of lesions.
The area under the ROC curve for malignancy detection was 0.893 for MammouS-N and 0.923 for hand-held ultrasound, without significant difference (p=0.207).
Moderate-to-substantial BI-RADS concordance (Cohen’s κ = 0.45; weighted κ = 0.65) with more downgrades noted in benign and malignant lesions.

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Prospective trial evaluates diagnostic performance of new ultrasound device in breast lesions, suggesting strong efficacy.

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Rho et al. (2026) studied this question.

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