Abstract
Objectives
To assess the diagnostic performance of a new device for in situ label-free fluorescence spectral analysis of breast masses in freshly removed surgical specimens, in preparation for its clinical development.
Methods
Sixty-four breast masses from consenting patients who had undergone either a lumpectomy or a mastectomy were included. Label-free fluorescence spectral acquisitions were obtained with a 25G fibre-containing needle inserted into the mass. Data from benign and malignant masses were compared to establish the most discriminating thresholds and measurement algorithms. Accuracy was verified using the bootstrap method.
Results
The final histological examination revealed 44 invasive carcinomas and 20 benign lesions. The maximum intensity of fluorescence signal was discriminant between benign and malignant masses (p < .0001) whatever their sizes. Statistical analysis indicated that choosing five random measurements per mass was the best compromise to obtain high sensitivity and high negative predictive value with the fewest measurements. Thus, malignant tumours were identified with a mean sensitivity, specificity, negative and positive predictive value of 98.8%, 85.4%, 97.2% and 93.5%, respectively.
Conclusion
This new in situ tissue autofluorescence evaluation device allows accurate discrimination between benign and malignant breast masses and deserves clinical development.
Key Points
• A new device allows in situ label-free fluorescence analysis of ex vivo breast masses
• Maximum fluorescence intensity discriminates benign from malignant masses (p < .0001)
• Five random measurements allow a high negative predictive value (97.2%)
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Acknowledgements
We would like to thank the various biological resource centres for providing the paraffin blocks required for a centralized histological review.
We would also like to thank Lionel Auffray from the Fluids, Automatic and Thermal Systems Laboratory for his engineering expertise, particularly in high-quality 3D printing and Yuki Takahashi for editing this manuscript.
Funding
This study has received funding by Nodea Medical.
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The scientific guarantor of this publication is MC Mathieu, MD
Conflict of interest
The authors of this manuscript declare relationships with the following companies: Nodea Medical.
Statistics and biometry
MedPass International (France) kindly provided statistical analysis for this manuscript.
Informed consent
Written informed consent was obtained from all subjects (patients) in this study.
Ethical approval
Institutional review board approval was obtained.
Methodology
• prospective
• observational
• multicentre study
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Mathieu, MC., Toullec, A., Benoit, C. et al. Preclinical ex vivo evaluation of the diagnostic performance of a new device for in situ label-free fluorescence spectral analysis of breast masses. Eur Radiol 28, 2507–2515 (2018). https://doi.org/10.1007/s00330-017-5228-7
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DOI: https://doi.org/10.1007/s00330-017-5228-7