Clinical trial · Interventional
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge: A Prospective, Exploratory Diagnostic Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
Nipple discharge is one of the common symptoms of breast disease patients. Nipple discharge can be divided into physiological and pathological nipple discharge (PND). Among patients with PND symptoms who undergo biopsy, 5%-21% of them are malignant, and the risk of malignancy increases with age. The primary diagnostic imaging methods for PND patients include mammography and breast ultrasound. Nearly half of PND patients who undergo traditional mammography and ultrasound examination have negative findings, but this does not rule out the presence of malignant lesions. Central duct excision is the gold standard for PND diagnosis, but invasive surgery without imaging guidance can lead to some complications. Magnetic Resonance Ductography (MRD), which uses water imaging technology to visualize the inside of the duct without contrast injection, can show imaging features of ductal lesions such as filling defects, irregularities of duct walls, and ductal obstruction. However, previous studies have shown that the signal-to-noise ratio of MRD images needs to be improved. Microscopy coil has the characteristics of small voxels and high spatial resolution, making it suitable for high signal-to-noise ratio imaging of small superficial structures. This provides a hardware foundation for improving the quality of MRD images. Therefore, in this study, the investigators aim to use the 3T MR instrument and microscopy coil to perform non-invasive high-resolution Magnetic Resonance Ductography (HR-MRD) on PND patients to evaluate the ability of HR-MRD to detect PND causes and the imaging features of duct-related lesions on HR-MRD, to assist in the accurate diagnosis and treatment of PND.
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 |
| Nipple Discharge | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRD + HR-MRD
- interventionNames
- Diagnostic Test: Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD)
Primary outcomes (1)
- measure
- Analyze the sensitivity and specificity of HR-MRD in detecting lesions that require surgical excision in patients with PND
- timeFrame
- 15 months
Secondary outcomes (2)
- measure
- Analyze the PPV and NPV of HR-MRD in detecting lesions that require surgical excision in patients with PND
- timeFrame
- 15 months
- measure
- The difference of detection sensitivity between HR-MRD and MRD in identifying lesions requiring surgical excision
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged between 18 and 75 years old. * Pathological nipple discharge patients who received treatment at Sun Yat-sen Memorial Hospital. The diagnostic criteria for pathological nipple discharge include unilateral, single duct orifice, and spontaneous discharge of serous or bloody fluid. Patients who meet any of the above criteria are considered as pathological discharge. * Willing to sign an informed consent form for clinical research and undergo HR-MRD and MRD examination. Exclusion Criteria: * Patients who have undergone surgery on the nipple-areolar complex of the PND breast side within the past year. * Patients who have claustrophobia or metal implants in their body, which are not suitable for MRI scans. * Patients who are pregnant or breastfeeding.
References
Publications (14)
- BACKGROUNDSeltzer MH, Perloff LJ, Kelley RI, Fitts WT Jr. The significance of age in patients with nipple discharge. Surg Gynecol Obstet. 1970 Sep;131(3):519-22. No abstract available. PMID 5454537
- BACKGROUNDOrel SG, Dougherty CS, Reynolds C, Czerniecki BJ, Siegelman ES, Schnall MD. MR imaging in patients with nipple discharge: initial experience. Radiology. 2000 Jul;216(1):248-54. doi: 10.1148/radiology.216.1.r00jn28248. PMID 10887256
- BACKGROUNDKanemaki Y, Kurihara Y, Itoh D, Kamijo K, Nakajima Y, Fukuda M, Van Cauteren M. MR mammary ductography using a microscopy coil for assessment of intraductal lesions. AJR Am J Roentgenol. 2004 May;182(5):1340-2. doi: 10.2214/ajr.182.5.1821340. No abstract available. PMID 15100142
- BACKGROUNDBhattarai N, Kanemaki Y, Kurihara Y, Nakajima Y, Fukuda M, Maeda I. Intraductal papilloma: features on MR ductography using a microscopic coil. AJR Am J Roentgenol. 2006 Jan;186(1):44-7. doi: 10.2214/AJR.04.1600. PMID 16357375
- BACKGROUNDFu P, Kurihara Y, Kanemaki Y, Okamoto K, Nakajima Y, Fukuda M, Maeda I. High-resolution MRI in detecting subareolar breast abscess. AJR Am J Roentgenol. 2007 Jun;188(6):1568-72. doi: 10.2214/AJR.06.0099. PMID 17515378
- BACKGROUNDHirose M, Nobusawa H, Gokan T. MR ductography: comparison with conventional ductography as a diagnostic method in patients with nipple discharge. Radiographics. 2007 Oct;27 Suppl 1:S183-96. doi: 10.1148/rg.27si075501. PMID 18180226
- BACKGROUNDKanemaki Y, Kurihara Y, Okamoto K, Nakajima Y, Fukuda M, Maeda I, Akiyama F. Ductal carcinoma in situ: correlations between high-resolution magnetic resonance imaging and histopathology. Radiat Med. 2007 Jan;25(1):1-7. doi: 10.1007/s11604-006-0091-5. Epub 2007 Jan 25. PMID 17225046