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

Primary Purpose

Breast Neoplasms, Nipple Discharge

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD)
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. Patients who have obtained pathological histological diagnosis. 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.

Sites / Locations

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRD + HR-MRD

Arm Description

Outcomes

Primary Outcome Measures

The difference of detection sensitivity between HR-MRD and MRD in identifying lesions requiring surgical excision
Comparison of the detection sensitivity of HR-MRD and MRD in identifying lesions requiring surgical excision in patients PND using histopathology as the gold standard. Histopathology positivity was defined as a pathological diagnosis requiring surgical excision, including malignant and high-risk lesions such as any type of breast cancer, intraductal papilloma, atypical hyperplasia, and nipple adenomatosis. HR-MRD/MRD positivity was defined as the presence of an occupying lesion detected on duct imaging. The detection sensitivity of HR-MRD/MRD was calculated as follows: (number of cases in which the histopathology gold standard was positive and HR-MRD/MRD duct imaging was positive/total number of cases with a positive histopathology gold standard) x 100%

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
September 14, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05812040
Brief Title
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge
Official Title
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge: A Prospective, Exploratory Diagnostic Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Nipple Discharge

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRD + HR-MRD
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD)
Intervention Description
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 Outcome Measure Information:
Title
The difference of detection sensitivity between HR-MRD and MRD in identifying lesions requiring surgical excision
Description
Comparison of the detection sensitivity of HR-MRD and MRD in identifying lesions requiring surgical excision in patients PND using histopathology as the gold standard. Histopathology positivity was defined as a pathological diagnosis requiring surgical excision, including malignant and high-risk lesions such as any type of breast cancer, intraductal papilloma, atypical hyperplasia, and nipple adenomatosis. HR-MRD/MRD positivity was defined as the presence of an occupying lesion detected on duct imaging. The detection sensitivity of HR-MRD/MRD was calculated as follows: (number of cases in which the histopathology gold standard was positive and HR-MRD/MRD duct imaging was positive/total number of cases with a positive histopathology gold standard) x 100%
Time Frame
15 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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. Patients who have obtained pathological histological diagnosis. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Hu, MD.
Phone
+86 13760765813
Email
huyue57@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Hu, MD.
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Hu, MD.
Phone
+86 13760765813
Email
huyue57@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge

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