Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge
- Conditions
- Nipple DischargeBreast Neoplasms
- Interventions
- Diagnostic Test: Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD)
- Registration Number
- NCT05812040
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 88
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MRD + HR-MRD Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD) -
- Primary Outcome Measures
Name Time Method Analyze the sensitivity and specificity of HR-MRD in detecting lesions that require surgical excision in patients with PND 15 months
- Secondary Outcome Measures
Name Time Method The difference of detection sensitivity between HR-MRD and MRD in identifying lesions requiring surgical excision 15 months Analyze the PPV and NPV of HR-MRD in detecting lesions that require surgical excision in patients with PND 15 months
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China