Clinical trial NCT05812040: Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge
Official title: Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge: A Prospective, Exploratory Diagnostic Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Nipple Discharge
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
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:
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
timeFrame: 15 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yue Hu, MD.
role: PRINCIPAL_INVESTIGATOR
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