Abstract
Purpose
To determine the reproducibility, accuracy, and quantitative values of the auto strain ratio system (ASRS)—a newly developed strain elastography-based program.
Materials and methods
First, the accuracy of ASRS was verified using a breast phantom. A prospective clinical study was then performed in patients. Two hundred and one women (mean age 52.4 years ± SD 14.5) with 232 breast lesions (177 benign and 55 malignant) were enrolled in this study. We assessed the correlation between ASRS and manual strain ratio (MSR), calculating the diagnostic performance to determine the cut-off. The area under the receiver operating characteristic curve (AUC) was calculated.
Results
ASRS was strongly correlated with the subtle differences in phantom stiffness (R = 0.87). In the clinical study, there was a significant correlation between MSR and ASRS with R = 0.79 (P < 0.001). ASRS (cut-off = 3.9) had a sensitivity of 81.8%, specificity of 88.7%, accuracy of 87.1%, positive predictive value of 69.2%, and negative predictive value of 94%. The AUC of ASRS was 0.89.
Conclusion
The findings from this study have demonstrated that it is possible to quantify strain elastography and control its accuracy. ASRS is expected to contribute to the standardization of breast elastography.
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Acknowledgements
We thank the following employees of Hitachi, Ltd. for contributing to the development of ASRS technology in this study: Koji Waki and Naoyuki Murayama.
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Conflict of interest
Kazutaka Nakashima has received research grants from Hitachi, Ltd. Akiko Mizutou and Sayaka Sakurai declare that they have no conflict of interest.
Funding
Funding was provided by Grants-in-aid for Scientific Research; scientific research fund (Grant no. 25461855).
Informed consent
Informed consent was obtained from all individual participants included in the study.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Nakashima, K., Mizutou, A. & Sakurai, S. Auto strain ratio system for the quality control of breast strain elastography. J Med Ultrasonics 45, 261–268 (2018). https://doi.org/10.1007/s10396-017-0830-5
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DOI: https://doi.org/10.1007/s10396-017-0830-5