Clinical trial · Interventional
Diagnostic Utility of MRI in Female Patients With Nipple Discharge: A Prospective Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Disorder of Nipple | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRI
- description
- Patients who have undergone mammography, breast sonography, and planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge.
- interventionNames
- Device: MRI
Primary outcomes (4)
- measure
- Sensitivity
- timeFrame
- Day 1
- description
- Sensitivity of MRI in detecting breast cancer in women with pathologic nipple discharge. \[Number of patients with positive MRIs confirmed with biopsy / (Number of patients with positive MRIs confirmed with biopsy + Number of patients with negative MRIs who present within 1 year with breast cancer)\]
- measure
- Specificity
- timeFrame
- Day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * female patients with unilateral and bloody nipple discharge OR unilateral and clear nipple discharge * clinical decision to have contrast enhanced MRI Exclusion Criteria: * male gender * non-English speakers * age \< 21 years * lack of capacity to give legally effective consent
References
Publications (18)
- BACKGROUNDKooistra BW, Wauters C, van de Ven S, Strobbe L. The diagnostic value of nipple discharge cytology in 618 consecutive patients. Eur J Surg Oncol. 2009 Jun;35(6):573-7. doi: 10.1016/j.ejso.2008.09.009. Epub 2008 Nov 4. PMID 18986790
- BACKGROUNDLorenzon M, Zuiani C, Linda A, Londero V, Girometti R, Bazzocchi M. Magnetic resonance imaging in patients with nipple discharge: should we recommend it? Eur Radiol. 2011 May;21(5):899-907. doi: 10.1007/s00330-010-2009-y. Epub 2010 Nov 30. PMID 21116634
- BACKGROUNDFisher CS, Margenthaler JA. A look into the ductoscope: its role in pathologic nipple discharge. Ann Surg Oncol. 2011 Oct;18(11):3187-91. doi: 10.1245/s10434-011-1962-2. Epub 2011 Aug 23. PMID 21861230
- BACKGROUNDHussain AN, Policarpio C, Vincent MT. Evaluating nipple discharge. Obstet Gynecol Surv. 2006 Apr;61(4):278-83. doi: 10.1097/01.ogx.0000210242.44171.f6. PMID 16551379
- BACKGROUNDRissanen T, Reinikainen H, Apaja-Sarkkinen M. Breast sonography in localizing the cause of nipple discharge: comparison with galactography in 52 patients. J Ultrasound Med. 2007 Aug;26(8):1031-9. doi: 10.7863/jum.2007.26.8.1031. PMID 17646365
- BACKGROUNDSabel MS, Helvie MA, Breslin T, Curry A, Diehl KM, Cimmino VM, Chang AE, Newman LA. Is duct excision still necessary for all cases of suspicious nipple discharge? Breast J. 2012 Mar-Apr;18(2):157-62. doi: 10.1111/j.1524-4741.2011.01207.x. Epub 2011 Dec 30. PMID 22211878
- BACKGROUNDBahl M, Baker JA, Greenup RA, Ghate SV. Diagnostic Value of Ultrasound in Female Patients With Nipple Discharge. AJR Am J Roentgenol. 2015 Jul;205(1):203-8. doi: 10.2214/AJR.14.13354. PMID 26102400
- Gray RJ, Pockaj BA, Karstaedt PJ. Navigating murky waters: a modern treatment algorithm for nipple discharge. Am J Surg. 2007 Dec;194(6):850-4; discussion 854-5. doi: 10.1016/j.amjsurg.2007.08.027.