Using high-resolution MRI to evaluate breast duct issues in patients with abnormal nipple discharge
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge: A Prospective, Exploratory Diagnostic Study
This study is testing a new MRI technique to see if it can better help women with abnormal nipple discharge find out if there are any issues in their breast ducts without needing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05812040 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of High-Resolution Magnetic Resonance Ductography (HR-MRD) in diagnosing pathological nipple discharge (PND) in female patients aged 18 to 75. The study aims to improve diagnostic accuracy for PND, which can sometimes indicate breast malignancy, by utilizing advanced MRI techniques that visualize ductal lesions without the need for invasive procedures. Participants will undergo HR-MRD and standard MRD examinations to assess the presence of abnormalities in the breast ducts. The trial is conducted at Sun Yat-sen Memorial Hospital, focusing on patients who meet specific criteria for PND.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 75 with unilateral pathological nipple discharge.
Not a fit: Patients who have had recent surgery on the nipple-areolar complex, have claustrophobia, or have metal implants unsuitable for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of breast conditions, potentially reducing unnecessary surgeries and improving patient outcomes.
How similar studies have performed: Previous studies have shown promise in using MRI techniques for breast imaging, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yue Hu, MD. — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Yue Hu, MD.
- Email: huyue57@mail.sysu.edu.cn
- Phone: +86 13760765813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.