Skip to main content
OpenTrials
Completed

NCT Number: NCT05812040

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Analyze the sensitivity and specificity of HR-MRD in detecting lesions that require surgical excision in patients with PND

    Time frame: 15 months

Secondary outcomes

  1. Analyze the PPV and NPV of HR-MRD in detecting lesions that require surgical excision in patients with PND

    Time frame: 15 months

  2. The difference of detection sensitivity between HR-MRD and MRD in identifying lesions requiring surgical excision

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2023
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.