Diagnostic Utility of MRI in Female Patients With Nipple Discharge: A Prospective Trial

Plain-language summary

The purpose of the proposed prospective study is to determine the diagnostic value of MRI for the evaluation of patients with pathologic nipple discharge. Breast surgeons will identify clinic patients with pathologic nipple discharge (unilateral and bloody or unilateral and clear) and refer them for breast MRI. When the clinical team notifies the study team that an MRI has been ordered for that purpose, the study team will consent patients to document the results and follow-up. The study team will not be obtaining MRI's on patients for research purposes only. The following data will be collected and analyzed: patient age, characteristics of the discharge (laterality, spontaneous versus expressed, duration of time, color, presence of blood), imaging workup and findings, BI-RADS final assessment categories, pathology results from core biopsy and/or surgical excision, and clinical and radiologic follow-up data during the two years after presentation. Participation in this study poses minimal risk to patients. Risks to the subjects include loss of confidentiality and unnecessary breast biopsy. The risks associated with MRI are minimal; however, since a gadolinium-based contrast agent will be administered for the MRI, patients with compromised renal function and patients who are pregnant will be excluded from the study.

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Trial details