Abstract
Objectives
To evaluate the diagnostic accuracy of breast MRI in identifying lesions requiring excision for patients with suspicious nipple discharge but normal mammograms and ultrasounds.
Methods
Between September 2013 and May 2019, 106 female participants (mean age 57.9 years) were consecutively included in this prospective multicenter study; 102 were retained for analysis. MRI was considered negative in the absence of suspicious enhancement and positive in cases of ipsilateral abnormal enhancement (BI-RADS 3 to 5). Final diagnoses were based on histological findings of surgical or percutaneous biopsies or at 1-year follow-up. We considered all lesions requiring excision found on pathology (papilloma, atypia, nipple adenomatosis, or cancer) as positive results. We considered spontaneous resolution of the discharge at 1 year as a negative result.
Results
MRI showed ipsilateral abnormal enhancement in 54 patients (53%) revealing 46 lesions requiring excision (31 benign papillomas, 5 papillomas with atypia, 2 nipple adenomatosis, and 8 cancers) and 8 benign lesions not requiring excision. No suspicious enhancement was found in the remaining 48 participants (47%). Forty-two were followed up at 1 year with spontaneous resolution of the discharge and six underwent surgery (revealing 2 benign papillomas). MRI diagnostic accuracy for the detection of a lesion requiring excision was as follows: sensitivity 96%, specificity 85%, positive predictive value 85%, and negative predictive value 96%.
Conclusion
In patients with suspicious nipple discharge and normal mammogram and ultrasound, MRI demonstrates excellent performance to identify lesions for which excision is required. Normal MRI indicates it is safe to propose follow-up only management, thus avoiding unnecessary duct excision.
Trial registration
ClinicalTrials.gov NCT02819362
Key Points
• Breast MRI can be useful for the management of patients with suspicious nipple discharge and negative mammogram and ultrasound.
• MRI detected a lesion requiring excision in 46 participants (45%) with unexplained discharge.
• If breast MRI is negative, follow-up is a safe alternative for these patients.
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Abbreviations
- ACR:
-
American College of Radiology
- DCIS:
-
Ductal carcinoma in situ
- IDC:
-
Invasive ductal carcinoma
- NME:
-
Non-mass enhancement
- NPV:
-
Negative predictive value
- PPV:
-
Positive predictive value
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Acknowledgements
The authors thank Pippa McKelvie-Sebileau for medical editing in English.
Funding
This study has received funding from the French Society of Women’s Imaging (SIFEM).
The Funder has no role in the design and conduct of the study: collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript and decision to submit the manuscript for publication.
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The scientific guarantor of this publication is Dr M Boisserie-Lacroix
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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.
Statistics and biometry
Professor Simone Mathoulin-Pélissier and Doctor Stéphanie Hoppe (Clinical and Epidemiological Research Unit) kindly provided statistical advice for this manuscript.
One of the authors has significant statistical expertise (Véronique Brouste).
No complex statistical methods were necessary for this paper.
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Written informed consent was obtained from all subjects (patients) in this study.
Written informed consent was waived by the Institutional Review Board.
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Approved as National Clinical Trial.
Institutional Review Board approval was obtained.
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• prospective
• diagnostic/observational
• multicenter study
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Dr. Stéphanie Hoppe is deceased.
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Boisserie-Lacroix, M., Doutriaux-Dumoulin, I., Chopier, J. et al. Diagnostic accuracy of breast MRI for patients with suspicious nipple discharge and negative mammography and ultrasound: a prospective study. Eur Radiol 31, 7783–7791 (2021). https://doi.org/10.1007/s00330-021-07790-4
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DOI: https://doi.org/10.1007/s00330-021-07790-4