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

March 26, 2024 updated by: Yue Hu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRD + HR-MRD
Diagnostic test: Magnetic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analyze the sensitivity and specificity of HR-MRD in detecting lesions that require surgical excision in patients with PND
Time Frame: 15 months
15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Analyze the PPV and NPV of HR-MRD in detecting lesions that require surgical excision in patients with PND
Time Frame: 15 months
15 months
The difference of detection sensitivity between HR-MRD and MRD in identifying lesions requiring surgical excision
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Yue Hu, MD., Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

April 1, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2023-122-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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