RecruitingNot ApplicableNCT05812040

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


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

88 participants

Start Date

Mar 2, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a high-resolution MRI technique for the breast ducts can better detect and locate the cause of abnormal nipple discharge compared to standard imaging methods. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have spontaneous nipple discharge that is abnormal — specifically unilateral (one breast), from a single duct, and the fluid is bloody or watery - You are being evaluated at Sun Yat-sen Memorial Hospital - You are willing to have both the experimental and standard MRI scans **You may NOT be eligible if...** - You have discharge from both breasts or multiple ducts - Your discharge is not spontaneous (only happens when squeezed) - You are not in the appropriate age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTMagnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD)

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


Locations(1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05812040


Related Trials