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

NCT06033573 | Unknown

• 1 other identifier: 0519-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nipple Discharge

Keywords

pathologic nipple discharge; contrast-enhanced spectral mammography

Outcome Measures

Primary Outcomes (1)

• Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging

  Changes include any of the following: 1. Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10) 2. Any changes in the number, location and\\or size (maximum and minimum diameters) of all lesions found 3. 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 Outcomes (5)

• Diagnostic accuracy of delayed ductal imaging results for the nature of the lesion

  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.

  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

  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.

  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.

  4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography

Other Outcomes (2)

• The rate of reported examination-related adverse events occurred within 7 days of delayed ductal imaging.

  7 days post delayed ductal imaging.

• The average gland dose of delayed ductal imaging.

  During imaging procedure

Study Arms (1)

Contrast-enhanced spectral mammography arm

EXPERIMENTAL

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

Interventions

contrast-enhanced spectral mammography DIAGNOSTIC_TEST

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

Contrast-enhanced spectral mammography arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Galactorrhea

Condition Hierarchy (Ancestors)

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

Study Officials

• Fan Yang, Dr.

  Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan Yang, Dr.

CONTACT

008685726114; fyang@vip.163.com

Juan Tao, Dr.

CONTACT

008685726114; taojuan@hust.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: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)