Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Mammography

Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Spectral Mammography: an Exploratory Study

The goal of the prospective, interventional, self-control, open, single-center clinical study: is to evaluate the value of the delayed ductal imaging of contrast enhanced Spectral Mammography acquired in 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography for the clinical diagnosis of patients with suspected pathologic nipple discharge.

The main questions aim to answer are:

1. Percentage of changes from baseline in imaging diagnosis caused by the results of delayed imaging.
2. The rate of reported examination-related adverse events occurred within 7 days of the delayed ductal imaging.
3. The average gland dose (AGD) of delayed ductal imaging.

After enrollment, subjects underwent CESM again within 4-6 hours post completing previous routine ductography to obtain a late-phase ductal image, which contains a low-energy image and a subtracted image obtained from the post processing.

Study Overview

• Status: Recruiting
• Conditions: Nipple Discharge
• Intervention / Treatment: Diagnostic test: contrast-enhanced spectral mammography

Detailed Description

As an exploratory study, the study plans to conduct another imaging using contrast-enhanced spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography, so as to explore the optimization of the ductography technique and attempt to make a systematic description of the mammary duct structure in the Chinese population of patients with pathological nipple discharge, and thus to assess the clinical value of this delayed imaging protocol, including the effectiveness of the diagnostic dimension of the disease and the safety of the radiation dose and the degree of patient tolerance.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fan Yang, Dr.; Phone Number: 008685726114; Email: fyang@vip.163.com
• Study Contact Backup: Name: Juan Tao, Dr.; Phone Number: 008685726114; Email: taojuan@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Juan Tao, Dr.; Phone Number: 008685726114; Email: taojuan@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Females aged 18-65 years old
• Completed routine iopromide 370 mgI/ml enhanced ductography for initial clinical diagnosis of suspected pathological nipple discharge, under the recommendation of the clinician
• Signed informed consent form for this study (signature and date)
• Committed to complying with study procedures and cooperating with the conducting of the full study process
• For women of childbearing age, should have taken contraceptive measures for at least one month prior to screening and must have a negative serum or urine pregnancy test, meanwhile committed to take contraceptive measures during the entire study and continue until a specified time after the end of the study

Exclusion Criteria:

• Pregnant or lactating women
• Experienced any episode of adverse events or discomfort after ductography with iopromide 370 mgI/ml
• Had any history of breast surgery, such as having undergone any invasive examination or surgical treatment due to the studied disease, including but not limited to breast duct micro-endoscopy, puncture biopsy, surgery, etc
• The ductal discharge symptom is more likely caused by other diagnosed/highly suspected diseases rather than a breast lesion, such as pituitary adenomas
• Other conditions are inappropriate for participation in this study judged by the investigator, such as the patient had difficulty to cooperate with ductography procedure, for example, loss of consciousness, communication impairment or nipple anomalies, and overly slender ducts

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contrast-enhanced spectral mammography arm; Subjects receiving contrast-enhanced spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography	Diagnostic test: contrast-enhanced spectral mammography; After enrollment, subjects should undergo contrast-enhanced spectral mammography again within 4-6 hours post completing previous routine ductography to obtain a late-phase ductal image, which contains a low-energy image and a subtracted image obtained from the post processing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging	Changes include any of the following: Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10); Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found; Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard	4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of delayed ductal imaging results for the nature of the lesion	Accuracy = (Number of true positive + Number of true negative) /total number x 100% with using pathological findings as reference standard	4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging in patients with dense breasts.	Changes include any of the following: Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10); Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found; Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard	4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging in patients with non-palpable breast mass/no abnormal findings on palpation	Changes include any of the following: Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10); Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found; Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard	4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Kappa values for the evaluation of diagnostic imaging results of delayed ductal imaging by different radiologists.	Evaluate the agreement on the diagnostic evaluation of delayed images by assessors using the Kappa test.	4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Scores for diagnostic confidence of radiologists before and after obtaining delayed ductal imaging result.	on a 5-point rating scale (1-5)	4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of reported examination-related adverse events occurred within 7 days of delayed ductal imaging.	Any discomfort and associated medical diagnoses post ductal imagine	7 days post delayed ductal imaging.
The average gland dose of delayed ductal imaging.	Total radiation of low-energy and subtracted images of delayed ductal imaging from the craniocaudal projection (CC) and the mediolateral projection (ML) of either mammary gland	During imaging procedure

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Fan Yang, Dr., Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pathologic nipple discharge; contrast-enhanced spectral mammography
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Lactation Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Galactorrhea
• Other Study ID Numbers: 0519-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: China Policy does not allow investigator to disclose individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No