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

NCT05812040 | Recruiting

• 1 other identifier: SYSKY-2023-122-02
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Nipple Discharge

Outcome Measures

Primary Outcomes (1)

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

  15 months

Secondary Outcomes (2)

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

  15 months

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

  15 months

Study Arms (1)

MRD + HR-MRD

OTHER

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

Interventions

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

MRD + HR-MRD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Breast Neoplasms; Galactorrhea

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lactation Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Yue Hu, MD.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Hu, MD.

CONTACT

+86 13760765813; huyue57@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 13, 2023
• Study Start: March 2, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)