Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge: A Prospective, Exploratory Diagnostic Study

Conditions
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Breast Neoplasms, Nipple Discharge

Intervention / Treatment
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* Diagnostic Test: Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD)


Participation Criteria
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Eligibility Criteria
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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. Patients who have obtained pathological histological diagnosis. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRD + HR-MRD<br> | Diagnostic Test: Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD)<br>* all participants will receive Magnetic Resonance Ductography (MRD) and High-Resolution Magnetic Resonance Ductography (HR-MRD) examination, using breast dedicated coil and microscopic coil, respectively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of detection sensitivity between HR-MRD and MRD in identifying lesions requiring surgical excision | Comparison of the detection sensitivity of HR-MRD and MRD in identifying lesions requiring surgical excision in patients PND using histopathology as the gold standard. Histopathology positivity was defined as a pathological diagnosis requiring surgical excision, including malignant and high-risk lesions such as any type of breast cancer, intraductal papilloma, atypical hyperplasia, and nipple adenomatosis. HR-MRD/MRD positivity was defined as the presence of an occupying lesion detected on duct imaging. The detection sensitivity of HR-MRD/MRD was calculated as follows: (number of cases in which the histopathology gold standard was positive and HR-MRD/MRD duct imaging was positive/total number of cases with a positive histopathology gold standard) x 100% | 15 months |